Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001016325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
8/04/2026
Date registered
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18/08/2026
Date last updated
Help: Date last updated
16/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
18/08/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Gait Training in Dementia
Scientific title
Evaluating of Gait Characteristic following The Rehabilitation of Gait in Dementia (ReGait-DEM)
Additional trial identifiers [1] 316988 0
None
Universal Trial Number (UTN)
Trial acronym
ReGait-DEM
Related trial records

Health condition
Health condition(s) studied:
Moderate Dementia 341450 0
Condition category
Condition code
Physical Medicine / Rehabilitation 337510 337510 0 0
Physiotherapy
Physical Medicine / Rehabilitation 337511 337511 0 0
Occupational therapy
Neurological 337512 337512 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
A pilot study will be conducted involving 24 older adults with moderate dementia recruited from Hospital Canselor Tuanku Muhriz (HCTM), Universiti Kebangsaan Malaysia. Participants will be approached face-to-face at the Occupational Therapy Unit of HCTM. The Rehabilitation on Gait in Dementia (ReGait-DEM) Training Program will be implemented monitoring by certified physiotherapist and occupational therapist. This structured 12-week intervention is designed to improve gait, balance, and cognitive function among older adults with moderate dementia. The program integrates motor and cognitive components through progressive dual-task and multitasking exercises targeting executive function and attentional processes (Keeffe et al., 2020). Upon confirmation of eligibility, caregivers will receive a one-to-one briefing, including a one-hour demonstration of the program within one week prior to commencement. The intervention consists of 3 level home-based rehabilitation sessions delivered twice weekly (total of 24 session in 12-week intervention). The duration and progression of the intervention may be adjusted according to the clinical needs of each participant. Participants will be provided with a training manual and a session Daily Training Log to support adherence. Monthly follow-up sessions will be conducted either face-to-face at the hospital or through home visits to review progress, address challenges, and modify the program as needed. The training protocol includes stretching, dual-task activities, gait and balance exercises and cognitive tasks, with an intended duration of at least 30 minutes per session at mild-to-moderate intensity. Outcome assessments will be conducted at baseline (0 exercise session), Week 6 (after 12 sessions of exercise), and Week 12 (after 24 sessions of exercise).

The ReGait-DEM Training Program will be administered as a caregiver-assisted home-based rehabilitation program. Caregivers will be trained by a certified physiotherapist and occupational therapist prior to the intervention and will guide the participants during each session at home using the provided training manual and Daily Training Log. The exercises will include progressive motor-cognitive and dual-task activities such as walking while counting, walking while repeating words, taking and placing a cup while turning, identifying colours while stepping, simple balance activities, gait practice, stretching, and functional movement tasks. These exercises will be performed according to the participant’s ability and progressed across three levels throughout the 12-week intervention.
Intervention code [1] 333732 0
Treatment: Other
Description of the comparator or control
The control group will continue to receive all usual care from their health care providers. They will be advised at the beginning of the study that those randomised to the control group will be on a waiting list to receive the experimental program at the end of 12-weeks. .
Control group
Active

Outcomes
Primary outcome [1] 345025 0
Gait Parameters such as Stride Length, Stride Velocity, Cadence, Gait Cycle, Double support time, Stance phase time, Swing phase time, Duration of Turning, Turning step no. and Turning Peak Velocity. This gait parameters will be assessed as a composite outcomes.
Timepoint [1] 345025 0
Outcome assessments will be conducted at baseline (0 exercise session), Week 6 (after 12 sessions of exercise), and Week 12 (after 24 sessions of exercise; primary timepoint)
Secondary outcome [1] 460201 0
Neuropsychiatric symptoms
Timepoint [1] 460201 0
Outcome assessments will be conducted at baseline (0 exercise session), Week 6 (after 12 sessions of exercise), and Week 12 (after 24 sessions of exercise)
Secondary outcome [2] 460202 0
Quality of Life
Timepoint [2] 460202 0
Outcome assessments will be conducted at baseline (0 exercise session), Week 6 (after 12 sessions of exercise), and Week 12 (after 24 sessions of exercise)
Secondary outcome [3] 460204 0
Functional independence
Timepoint [3] 460204 0
Outcome assessments will be conducted at baseline (0 exercise session), Week 6 (after 12 sessions of exercise), and Week 12 (after 24 sessions of exercise)

Eligibility
Key inclusion criteria
Each Program will be composed of one Caregiver and one participant with moderate dementia.

The participant moderate dementia must:
- Older adults aged greater than or equal to 60 years
- Moderate Dementia (Clinical Dementia Rating (CDR) Scale: 2, Montreal Cognitive Assessment (MoCA): 10-17)
- Participants must be ambulatory, either independently without assistive devices or with the use of walking aids (e.g., cane or walker), and capable of following simple one- to two-step commands
- Medically stable; with no acute illness that limits mobility.
- Have a primary caregiver willing and able to participate in training sessions.
- Low to moderate risk of fall person (Able to sustain more than 10 second in Single-Leg Stance Test)
- No significant eyes problem
- Provide informed consent

The Caregiver in this program must:
1)Live with the participant with dementia and/or providing some portion of their daily care including Activities of Daily Living in an informal capacity.
2) Be able to speak and understand English/Bahasa Malaysia
3) Residence within 30 km of the hospital sites.
4) Adequate vision, hearing, cognition and manual dexterity sufficient to understand the training given.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1) Older adults with mild and severe dementia
2) Cognitively healthy older adults without dementia.
3) Have an unstable cardiovascular condition, rheumatic disease that caused limitation of range of motion or pain.
4) Presence of musculoskeletal, orthopaedic and neurological impairments that would affect their gait
5) History of stroke and psychiatric disorders.
6) High Risk of falls
7) Unable to understand instructions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation using concealed, sequentially numbered envelopes opened by the participant after baseline assessment completed. Sequencing and randomization will be done by an external staff member not involved with the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be generated by computer software ( computerised sequence)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation will be conducted using G-Power version 3.1.9.4 software to ensure sufficient power to evaluate the significant differences between groups over time in gait of dementia for the pilot study. A minimum sample size of 10 participants is proposed for this pilot study, consistent with methodological guidance suggesting that 10–12 participants per group is sufficient to assess feasibility and gather preliminary effect estimates in early-phase trials (Julious, 2005). The sample size was calculated based on a two-tailed f-test with pre- and post-intervention.

Statistical test: ANOVA: Repeated measures, within-between interaction
Effect size: 0.45 (Fritz et al., 2013)
a err prob: 0.05
Power (1-ß err prob): 0.95
Sample size: 20; 10 participant per group

Given the vulnerability of individuals with moderate dementia, clinical trials in this population are often associated with higher attrition rates due to progressive cognitive decline, medical comorbidities, caregiver burden, hospitalization, and institutionalization. Previous reviews of dementia clinical trials have reported dropout rates ranging between 10-20% within three months, with longer studies often experiencing even higher attrition (Gauthier et al., 2016; Grill & Karlawish, 2010). Therefore, in the present trial, we conservatively estimate a 20% dropout rate for sample size calculations to ensure sufficient statistical power despite expected losses to follow-up. Inclusion of 20% potential dropouts as suggested in the latest study, the potential number of participants, n = 24, with 12 participants in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/04/2026
Date of last participant enrolment
Anticipated
Actual
22/05/2026
Date of last data collection
Anticipated
Actual
30/07/2026
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 28017 0
Malaysia
State/province [1] 28017 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 321585 0
University
Name [1] 321585 0
Universiti Kebangsaan Malaysia (UKM)
Country [1] 321585 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia (UKM)
Address
Country
Malaysia
Secondary sponsor category [1] 324386 0
None
Name [1] 324386 0
Address [1] 324386 0
Country [1] 324386 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320112 0
UKM RESEARCH ETHICS COMMITTEE (RECUKM)
Ethics committee address [1] 320112 0
Ethics committee country [1] 320112 0
Malaysia
Date submitted for ethics approval [1] 320112 0
24/04/2025
Approval date [1] 320112 0
28/11/2025
Ethics approval number [1] 320112 0
JEP-2024-202

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 149474 0
Dr Deepashini Harithasan
Address 149474 0
Faculty of Healthy Sciences, UKM, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia
Country 149474 0
Malaysia
Phone 149474 0
+60173078934
Fax 149474 0
Email 149474 0
[email protected]
Contact person for public queries
Name 149475 0
Firdaus bin Mohamad Tahir
Address 149475 0
Faculty of Healthy Sciences, UKM, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia
Country 149475 0
Malaysia
Phone 149475 0
+60143703907
Fax 149475 0
Email 149475 0
[email protected]
Contact person for scientific queries
Name 149476 0
Firdaus bin Mohamad Tahir
Address 149476 0
Faculty of Healthy Sciences, UKM, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia
Country 149476 0
Malaysia
Phone 149476 0
+60143703907
Fax 149476 0
Email 149476 0
[email protected]

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
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Can email the corresponding person at [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


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.