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Trial registered on ANZCTR
Registration number
ACTRN12625000774426
Ethics application status
Approved
Date submitted
26/05/2025
Date registered
22/07/2025
Date last updated
22/07/2025
Date data sharing statement initially provided
22/07/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparison of an online and centre-based group exercise program to improve balance for people with Parkinson's Disease
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Scientific title
Group telerehabilitation multimodal balance exercise by video conferencing for patients with Parkinson’s disease (PD): a pilot randomised study
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Secondary ID [1]
314272
0
Nil known
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Universal Trial Number (UTN)
U1111-1319-2171
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
parkinson's disease
336737
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Condition category
Condition code
Neurological
333235
333235
0
0
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Parkinson's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Up to 10 participants will complete 16 one-hour synchronous group telerehabilitation sessions of a multimodal balance exercise program conducted twice weekly over 8 weeks at each participant’s home. The sessions will be remotely instructed by a movement disorder physiotherapist with 17 years of clinical experience and 5 years of experience delivering telerehabilitation. All telerehabilitation sessions will be also assisted by an allied health assistant remotely.
Participants will be provided with a pair of 1-kilogram dumbbells to be used during the program. The type of exercises will remain the same over 8 weeks, and the level of difficulty, intensity, speed, or complexity will be progressively titrated upwards depending on the mastery of exercise as a whole group. The physiotherapist leading the group will assess their level of mastery and confidence from visual observation of participants’ reaction to the physical movements and their verbal feedback. They will be encouraged to exercise with a large amplitude of movement and at a moderate to vigorous intensity level (rated 4 to 8) as measured by the Borg Rating of Perceived Exertion (scale of 1 to 10). Participants will be advised on safety procedures such as having the support base within reach of arms and a water bottle for hydration.
The physiotherapist will instruct participants in the group to perform a wide range of exercises in both sitting and standing positions. Participants will be asked to continue each exercise for up to 1 minute before transitioning to the next. The exercises will be structured using the “FASTC” principle — an acronym for Functional training, Amplitude training, Strategy training, Timing, and Cognitive training—which are key components in prescribing physiotherapy exercises for people with PD.
The types of exercises include walking, sit-to-stand transitions, martial arts movements, stepping, balance, strength, and flexibility exercises.
All participants will perform the same exercise demonstrated by the physiotherapist. However, the level of balance challenge may be tailored to each individual’s ability and confidence using upper limbs to anchor to the support base (back of the chair). Participants will be initially asked to decide the level of balance challenge by themselves, with some guidance on their options. For example, single leg standing exercises can be completed anchoring on the back of the chair in one of three ways: with one hand on the support base, or one fingertip or no hands at all. Similarly, forward lunge stepping exercises can be completed with one hand on the support base, no hands or extending both arms sideways while stepping forward. The physiotherapist will monitor their performance and advise on altering the level of difficulty or suggesting any modifications.
The level of difficulty, intensity, speed and complexity will be tailored and progress for the group throughout the course of this program. These parameters will also be adjusted individually in a self-directed manner by participants or modified by the physiotherapist through observation of participants’ physical reactions to each exercise. Complexity will be introduced by adding a dual cognitive or manual task component to the exercise movement. For example, participants will be asked to name European cities while executing forward lunge stepping exercises, or to count down from 50 by 3s while executing squats with both arms extending forward.
The actual time spent performing exercises will be recorded in minutes for each session. The allied health assistant will also record duration of any interruptions due to internet connectivity issues and any periods of non-participation for each participant. Intervention fidelity will be assessed using a checklist completed by the allied health assistant during each session. The physiotherapist will review the checklist after each session. Participant adherence will be defined as the attendance rate over the 16 sessions.
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Intervention code [1]
330885
0
Treatment: Other
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Comparator / control treatment
Up to 10 participants will complete 16 one-hour group sessions of a multimodal balance exercise program conducted twice weekly over 8 weeks at the community rehabilitation centre. The sessions will be instructed by a movement disorder physiotherapist with 17 years of clinical experience. All 16 sessions will be also assisted by an allied health assistant.
Participants will be provided with a pair of 1-kilogram dumbbells to be used during the program. The type of exercises will remain the same over 8 weeks, and the level of difficulty, intensity, speed, or complexity will be progressively titrated upwards depending on the mastery of exercise as a whole group. The physiotherapist leading the group will assess their level of mastery and confidence from visual observation of participants’ reaction to the physical movements and their verbal feedback. They will be encouraged to exercise with a large amplitude of movement and at a moderate to vigorous intensity level (rated 4 to 8) as measured by the Borg Rating of Perceived Exertion (scale of 1 to 10). Participants will be advised on safety procedures such as having the support base within reach of arms and a water bottle for hydration.
The physiotherapist will instruct participants in the group to perform a wide range of exercises in both sitting and standing positions. Participants will be asked to continue each exercise for up to 1 minute before transitioning to the next. The exercises will be structured using the “FASTC” principle — an acronym for Functional training, Amplitude training, Strategy training, Timing, and Cognitive training—which are key components in prescribing physiotherapy exercises for people with PD.
The types of exercises include walking, sit-to-stand transitions, martial arts movements, stepping, balance, strength, and flexibility exercises.
All participants will perform the same exercise demonstrated by the physiotherapist. However, the level of balance challenge may be tailored to each individual’s ability and confidence using upper limbs to anchor to the support base (back of the chair). Participants will be initially asked to decide the level of balance challenge by themselves, with some guidance on their options. For example, single leg standing exercises can be completed anchoring on the back of the chair in one of three ways: with one hand on the support base, or one fingertip or no hands at all. Similarly, forward lunge stepping exercises can be completed with one hand on the support base, no hands or extending both arms sideways while stepping forward. The physiotherapist will monitor their performance and advise on altering the level of difficulty or suggesting any modifications.
The level of difficulty, intensity, speed and complexity will be tailored and progress for the group throughout the course of this program. These parameters will also be adjusted individually in a self-directed manner by participants or modified by the physiotherapist through observation of participants’ physical reactions to each exercise. Complexity will be introduced by adding a dual cognitive or manual task component to the exercise movement. For example, participants will be asked to name European cities while executing forward lunge stepping exercises, or to count down from 50 by 3s while executing squats with both arms extending forward.
The actual time spent performing exercises will be recorded in minutes for each session. The allied health assistant will also record duration of any interruptions such as having a toilet break or needing to rest longer while others are exercising, in minutes, for each participant. Intervention fidelity will be assessed using a checklist completed by the allied health assistant during each session. The physiotherapist will review the checklist after each session. Participant adherence will be defined as the attendance rate over the 16 sessions.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome measure is feasibility.
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Assessment method [1]
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This will be assessed using the recruitment rate (a number of patients enrolled per month) by auditing study enrolment logs, and the retention rate (treatment specific retention rate) by assessing attendance rate and follow up assessment completion rate and the withdrawal logs.
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Timepoint [1]
341198
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At 12 weeks from the completion of intervention (week 20)
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Primary outcome [2]
341469
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The primary outcome measure is acceptability.
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Assessment method [2]
341469
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This will be assessed with an online self-directed satisfaction survey using a 5-point Likert scale type questions.
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Timepoint [2]
341469
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At 12 weeks from the completion of intervention (week 20)
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Secondary outcome [1]
446746
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Evaluate non-motor experience of daily living
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Assessment method [1]
446746
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The Movement Disorders Society sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part I (0-52)
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Timepoint [1]
446746
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [2]
447631
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Evaluate motor experience of daily living
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Assessment method [2]
447631
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The Movement Disorders Society sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II (0-52)
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Timepoint [2]
447631
0
At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [3]
447636
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Evaluate overall motor function
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Assessment method [3]
447636
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The Movement Disorders Society sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III (0-132)
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Timepoint [3]
447636
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [4]
447701
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Evaluate PD specific health related quality of life
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Assessment method [4]
447701
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Parkinson's Disease Questionnaire (PDQ-39) (0-100)
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Timepoint [4]
447701
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [5]
447702
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Evaluate functioning of balance control system.
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Assessment method [5]
447702
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Mini Balance Evaluation Systems Test (MiniBESTest) (0 - 32)
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Timepoint [5]
447702
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [6]
447703
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Evaluate walking ability.
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Assessment method [6]
447703
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Timed-up-and-go test
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Timepoint [6]
447703
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [7]
447717
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Evaluate falls risk while completing cognitive dual task
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Assessment method [7]
447717
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Timed-up-and-go test cognitive dual task
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Timepoint [7]
447717
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [8]
447718
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Evaluate preferred walking speed in metres per second over a short duration.
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Assessment method [8]
447718
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10-meter-walk-test - preferred
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Timepoint [8]
447718
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [9]
447719
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Evaluate dynamic balance.
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Assessment method [9]
447719
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Four square step test
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Timepoint [9]
447719
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [10]
447722
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Evaluate falls risk.
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Assessment method [10]
447722
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The L test
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Timepoint [10]
447722
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [11]
447723
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Evaluate balance confidence in performing activities of daily living.
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Assessment method [11]
447723
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Activities-specific balance confidence scale
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Timepoint [11]
447723
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [12]
450115
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To evaluate falls risk
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Assessment method [12]
450115
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Timed-up-and-go test
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Timepoint [12]
450115
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [13]
450124
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Evaluate falls risk.
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Assessment method [13]
450124
0
Four square step test
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Timepoint [13]
450124
0
At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [14]
450125
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To evaluate walking ability.
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Assessment method [14]
450125
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The L test
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Timepoint [14]
450125
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [15]
450126
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To evaluate walking ability while completing cognitive dual task.
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Assessment method [15]
450126
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Timed-up-and-go test cognitive dual task
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Timepoint [15]
450126
0
At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [16]
450127
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To evaluate dynamic coordination
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Assessment method [16]
450127
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Four square step test
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Timepoint [16]
450127
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At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [17]
450128
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Evaluate fast walking speed in metres per second over a short duration.
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Assessment method [17]
450128
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10-meter-walk-test - fast
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Timepoint [17]
450128
0
At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [18]
450129
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To evaluate anticipatory postural control
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Assessment method [18]
450129
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Sub score of MiniBESTest
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Timepoint [18]
450129
0
At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [19]
450130
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To evaluate reactive postural control
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Assessment method [19]
450130
0
Sub score of MiniBESTest
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Timepoint [19]
450130
0
At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [20]
450131
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To evaluate sensory orientation
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Assessment method [20]
450131
0
Sub score of MiniBESTest
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Timepoint [20]
450131
0
At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Secondary outcome [21]
450132
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To evaluate dynamic gait
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Assessment method [21]
450132
0
Sub score of MiniBESTest
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Timepoint [21]
450132
0
At baseline (week 0), at immediately post-intervention (week 8), and at 12 weeks from the completion of intervention (week 20).
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Eligibility
Key inclusion criteria
Participants are eligible if they present with:
(1) a diagnosis of idiopathic PD from a movement disorders specialist and are deemed in need of a rehabilitation programme for balance and/or gait problems.
(2) mild to moderate disease (the Hoehn and Yahr Scale II – III),
(3) aged above 18 years,
(4) the ability to participate in an assessment and exercise group as determined by a movement disorders specialist,
(5) agreement to participate in 16 sessions of the intervention,
(6) have access to a high-speed internet connection at home and have information technology literacy to use the video conferencing telerehabilitation platform.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants will be excluded for the following reasons:
(1) untreated orthostatic hypotension that could cause falls,
(2) presence of another significant disorder that would additionally impact on gait/balance,
(3) presence of a medical condition that contraindicates exercise,
(4) already meeting 150 minutes per week of moderate to vigorous intensity physical activities,
(5) has a significant cognitive impairment as assessed with Montreal Cognitive Assessment score less than or equal to 19, or prior diagnosis of dementia,
(6) presence of moderate to severe hearing or visual impairment that makes it impossible to participate in group exercise.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants will be randomly assigned to either the intervention or the control group using a computer-generated randomization sequence to reduce selection bias. The allocation will be concealed from investigators enrolling the participants and access to the allocation will be blocked from the enrolling investigators. An independent investigator not involved in the recruitment will be responsible for generating the randomised sequence and will provide the group allocation to the enrolling investigator after the participant is enrolled.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation sequence. The study will utilise the Monash Health version of the Research Electronic Data Capture (REDCap) database packaging for generating randomisation sequence.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
28/07/2025
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Actual
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Date of last participant enrolment
Anticipated
27/10/2025
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Actual
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Date of last data collection
Anticipated
27/04/2026
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
27815
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Kingston Centre - Cheltenham
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Recruitment postcode(s) [1]
44009
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3192 - Cheltenham
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Funding & Sponsors
Funding source category [1]
318512
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Charities/Societies/Foundations
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Name [1]
318512
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Lions John Cockayne Memorial Fellowship Trust Fund
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Address [1]
318512
0
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Country [1]
318512
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Australia
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Primary sponsor type
Individual
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Name
Kantaro Ito - Kingston Centre/Monash Health
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Address
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Country
Australia
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Secondary sponsor category [1]
321237
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Hospital
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Name [1]
321237
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Monash Health
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Address [1]
321237
0
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Country [1]
321237
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317117
0
Monash Health Human Research Ethics Committee A
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Ethics committee address [1]
317117
0
https://monashhealth.org/research/resources/resource-library/
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Ethics committee country [1]
317117
0
Australia
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Date submitted for ethics approval [1]
317117
0
19/02/2025
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Approval date [1]
317117
0
23/05/2025
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Ethics approval number [1]
317117
0
REC-25-0000-041A
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Summary
Brief summary
Exercise improves wellbeing of people living with Parkinson’s disease (PD). However, travelling to and participating in exercise classes at a community centre may be difficult. This study will investigate whether an online PD targeted exercise program is acceptable and feasible for people living with PD. We will recruit up to 20 people with PD and allocate them randomly into two groups. Both groups will participate in a 1-hour exercise class twice a week for 8 weeks. Group 1 will participate in the online class and Group 2 in the face-to-face class. We will also investigate how this program can improve mobility and balance in people with PD.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
140050
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Mr Kantaro Ito
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Address
140050
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Monash Health - Kingston Centre, 400 Warrigal Road Cheltenham Victoria 3192
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Country
140050
0
Australia
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Phone
140050
0
+61 3 9265 1411
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Fax
140050
0
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Email
140050
0
[email protected]
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Contact person for public queries
Name
140051
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Kantaro Ito
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Address
140051
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Monash Health - Kingston Centre, 400 Warrigal Road Cheltenham Victoria 3192
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Country
140051
0
Australia
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Phone
140051
0
+61 3 9265 1411
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Fax
140051
0
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Email
140051
0
[email protected]
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Contact person for scientific queries
Name
140052
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Kantaro Ito
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Address
140052
0
Monash Health - Kingston Centre, 400 Warrigal Road Cheltenham Victoria 3192
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Country
140052
0
Australia
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Phone
140052
0
+61 3 9265 1411
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Fax
140052
0
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Email
140052
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
•
Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
•
Requires a scientifically sound proposal or protocol
•
Requires approval by an ethics committee
•
Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
•
All de-identified individual participant data
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
•
Systematic reviews and meta-analyses
•
Studies exploring new research questions
•
Health economic analyses
•
Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of:
15
years
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
Kantaro Ito, Principal investigator,
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Informed consent form
2025
[email protected]
Group Tele-EX pilot study Participant information Sheet Version 2.0.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF