Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000954628p
Ethics application status
Submitted, not yet approved
Date submitted
14/08/2023
Date registered
4/09/2023
Date last updated
4/09/2023
Date data sharing statement initially provided
4/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Motorized Movement Therapy in Non-ambulant Adults with Cerebral Palsy: A pilot study investigating Cardiometabolic Biomarkers, Health and Wellbeing Outcomes.
Scientific title
Motorized Movement Therapy in Non-ambulant Adults with Cerebral Palsy: A pilot study investigating Cardiometabolic Biomarkers, Health and Wellbeing Outcomes.
Secondary ID [1] 310033 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 330574 0
Non-ambulant 330575 0
Condition category
Condition code
Neurological 327410 327410 0 0
Other neurological disorders
Musculoskeletal 327411 327411 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 327412 327412 0 0
Physiotherapy
Cardiovascular 327413 327413 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will take part in a 10-minute trial of the MOTOmed to ensure no adverse responses (pain or behavioural) preventing ongoing participation and to ensure compatibility of their wheelchair with the device.

Eligible participants will take part in a 12-week home motorised cycling intervention.

Participants will be required to use the cycling device a minimum of four times per week. A minimum of 10 minutes per session is the recomended starting duration.

The device is set on the passive mode at 20 revolutions per minute. For participants who are able to engage the cycling device independently the passive mode will be automtically over ridden for the duration of time they are able to cycle independently. The device will convert back to passive mode automatically if they are unable to maintain the independent cycling. It is expected that the majority of participants will remain in the passive mode due to the significant level of disability.

Due to the level of disability of participants, all sessions will be facilitated and supervised by a family member or support worker who will also complete the written diary at the end of each session.

The written diary will include session date and duration (minutes). Muscle spasms will be recorded weekly.

Participants will undergo a series of blood test pre and post intervention and will fill in a series of surveys relating to pain, sleep, fatigue, leg activity and satisfaction.

In addition, a member of the research team will call the participant / legal guardian fortnightly to troubleshoot any concerns and provide additional guidance on progression as required. The primary investigator can be contacted during working hours if an issue arises.
Intervention code [1] 326453 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335275 0
Blood tests
Composite primary outcome
Fasting glucose, insulin, total cholesterol, triglycerides, High Density Lipoproteins-cholesterol (HDL), and calculated Low Density Lipoproteins -cholesterol (LDL), plus high-sensitivity C-reactive protein (hsCRP) will be obtained using a standardized study pathology request form.
Timepoint [1] 335275 0
Baseline and within 7 days of completing the trial (within week 13)
Primary outcome [2] 335276 0
Motomed Data
The Motomed cycling device collects and stores data pertaining to each episode of use.
The relevant data for each session includes date, time, active and passive duration (seconds), active and passive speed (revolutions per minute).
The motomed data is a composite primary outcome
Timepoint [2] 335276 0
This information will be downloaded from the device within one week of completion of the 12-week cycling intervention
Secondary outcome [1] 423695 0
Penn Spasm Frequency Scale (PSFS)
Timepoint [1] 423695 0
Spasms will be rated weekly for 12 weeks using the PSFS by participants or by carers if the participants are unable to self rate. The weekly spasms rating will take less than 5 minutes to complete.
Secondary outcome [2] 423696 0
Fatigue Assessment Scale (FAS).
Timepoint [2] 423696 0
Baseline and within 7 days of completing the trial (within week 13)
Secondary outcome [3] 423697 0
Leg Activity Measure (LegA).
Timepoint [3] 423697 0
Baseline and within 7 days of completing the trial (within week 13)
Secondary outcome [4] 423698 0
Non Communicating Adult Pain Checklist (NCAPC) will be used for proxy reporting of pain
Timepoint [4] 423698 0
Baseline and within 7 days of completing the trial (within week 13)
Secondary outcome [5] 423699 0
PROMIS SF 8 Pain Interference scale will be used for participants able to self-report pain
Timepoint [5] 423699 0
Baseline and within 7 days of completing the trial (within week 13)
Secondary outcome [6] 423700 0
PROMIS sleep disturbance SF- parent proxy
Timepoint [6] 423700 0
Baseline and within 7 days of completing the trial (within week 13)
Secondary outcome [7] 423701 0
PROMIS sleep disturbance SF- self report
Timepoint [7] 423701 0
Baseline and within 7 days of completing the trial (within week 13)
Secondary outcome [8] 423702 0
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
Timepoint [8] 423702 0
Within 7 days of completing the trial (within week 13)

Eligibility
Key inclusion criteria
• CP GMFCS Level IV & V
Current patient of YACDS or ITB Clinic
Age 18 years and older
Interested in increasing physical activity
Not currently using a cycling machine
Availability of carers to assist with MOTOmed use on a regular basis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Uncontrolled epilepsy
Uncontrolled pain
Presence of contractures preventing a lower limb cycling motion
Significant dystonia preventing placement and maintenance of lower limbs in position
Modified Ashworth Scale (MAS) score of 4 (affected parts rigid in flexion or extension)
History of non-traumatic lower limb fracture or low trauma fracture
Surgery or serial casting scheduled during the trial
Surgery within the prior 6 months unless medically cleared
Living greater than 60 minutes travel to SVHM
Wheelchair and device are incompatible

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analysis will be conducted for all data.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25069 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 40732 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 314211 0
Hospital
Name [1] 314211 0
St Vincent's Hospital Melbourne
Country [1] 314211 0
Australia
Funding source category [2] 314213 0
Other
Name [2] 314213 0
Murdoch Children's Research Institute
Country [2] 314213 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital Melbourne
Address
41 Victoria Parade
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 316138 0
Other
Name [1] 316138 0
Murdoch Children's Research Institute
Address [1] 316138 0
Royal Children's Hospital
50 Flemington Road
Parkville
VIC 3052
Country [1] 316138 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313336 0
St. Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 313336 0
41 Victoria Parade Fitzroy VIC 3065
Ethics committee country [1] 313336 0
Australia
Date submitted for ethics approval [1] 313336 0
14/08/2023
Approval date [1] 313336 0
Ethics approval number [1] 313336 0

Summary
Brief summary
Individuals with Cerebral Palsy who are reliant on wheelchairs for mobility have significantly reduced options for participating in physical activity and movement. For those with significant disabilities encompassing not only the musculoskeletal system but also cognition, behaviour and communication face a unique set of challenges requiring new and novel treatment options. In addition to the barriers of access and transport consideration also needs to be given to the timing of medications and feeds.
The MOTOmed is a motorised movement (cycling) device, accessed from a person’s wheelchair that provides an option to move for non-ambulant adults with CP. The passive rhythmical cycling motion provides movement at the hip, knee and ankle joints that is otherwise not possible for those with a lack of independent and functional active movement. This movement opportunity may be beneficial given that adults with CP are otherwise in static postures for the majority of their day and night.
The primary study aim is to investigate the effects of physical activity on cardiometabolic biomarkers in non-ambulant adults with CP. Commonly used measures of increased physical activity such as strength, walking speed and distance are not able to be used in this group of adults. Blood markers offer a way to measure the effects of physical activity with change possible within 1 to 3 months of moderate intensity exercise training in able-bodied individuals. Changes are anticipated to occur in the proposed population as participants are beginning from an extreme low or non-existent level of activity.
The secondary study aim is to explore the experience of MMT including any perceived benefits and burdens.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127782 0
Dr Carlee Holmes
Address 127782 0
St. Vincent's Hospital Melbourne41 Victoria ParadeFitzroy VIC 3065Murdoch Children's Research InstituteRoyal Children's Hospital50 Flemington RoadParkvilleVIC 3052
Country 127782 0
Australia
Phone 127782 0
+61 3 9288 4672
Fax 127782 0
Email 127782 0
carlee.holmes@mcri.edu.au
Contact person for public queries
Name 127783 0
Dr Carlee Holmes
Address 127783 0
St. Vincent's Hospital Melbourne41 Victoria ParadeFitzroy VIC 3065Murdoch Children's Research InstituteRoyal Children's Hospital50 Flemington RoadParkvilleVIC 3052
Country 127783 0
Australia
Phone 127783 0
+61 3 9288 4672
Fax 127783 0
Email 127783 0
carlee.holmes@mcri.edu.au
Contact person for scientific queries
Name 127784 0
Dr Carlee Holmes
Address 127784 0
St. Vincent's Hospital Melbourne41 Victoria ParadeFitzroy VIC 3065Murdoch Children's Research InstituteRoyal Children's Hospital50 Flemington RoadParkvilleVIC 3052
Country 127784 0
Australia
Phone 127784 0
+61 3 9288 4672
Fax 127784 0
Email 127784 0
carlee.holmes@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.