Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001203347
Ethics application status
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Approved
Date submitted
Help: Date submitted
1/11/2025
Date registered
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29/09/2026
Date last updated
Help: Date last updated
29/09/2026
Date data sharing statement initially provided
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29/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Robotic Gait and Balance Training for Children with Motor Movement Disorders: Evaluating Safety, Comfort, and Effectiveness
Scientific title
Evaluation of a Pediatric Gait Exoskeleton Assisted Rehabilitation (P-GEAR) systems for Balance and Gait Training respectively: A Randomized Controlled Trial in Children with Motor Movement Disorders.
Additional trial identifiers [1] 315226 0
Nil known
Universal Trial Number (UTN)
Trial acronym
REGAIN_CP
Related trial records

Health condition
Health condition(s) studied:
Motor Movement Disorders (Cerebral Palsy) in Children 338679 0
Condition category
Condition code
Neurological 334967 334967 0 0
Other neurological disorders
Musculoskeletal 336960 336960 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure

P.GEAR stands for Pediatric Gait Exoskeleton Assisted Rehabilitation. The system consists of three major subsystems: a treadmill, a body weight support (BWS) system, and a lower-limb exoskeleton with two robotic legs powered by motors that actuate the hip and knee joints. The mechanism supporting the exoskeleton also allows pelvic motion through two passive degrees of freedom.

During the intervention, participants will be assisted onto the treadmill and supported in standing using the BWS system. The exoskeleton legs will then be attached to the participant’s lower limbs using adjustable supportive braces. The P.GEAR controller, which is the controller panel, will provide assistance from P.GERA robot during treadmill walking based on the participant’s estimated range of motion and torque-generating capacity. The level of assistance will be adjusted so that support is provided as needed during the walking task.

Children with motor movement disorders, classified as Gross Motor Function Classification System (GMFCS) levels I–III, will participate in a structured P.GEAR robot-assisted treadmill training program. The intervention will be delivered by trained rehabilitation specialists. Each session will last approximately 30–40 minutes, including rest periods as required. Sessions will be provided three times per week over a period of 6–8 weeks.

The intervention intensity will be maintained at a low level, considering the age of the participants and the presence of motor impairments such as spasticity, reduced voluntary motor control, and limited walking tolerance. Treadmill speed will be set at approximately 0.2–0.5 km/h, depending on participant tolerance and therapist assessment. Intensity will be monitored using the Borg Rating of Perceived Exertion (RPE) scale, together with therapist observation of fatigue, discomfort, walking tolerance, and the need for rest breaks. The intervention will be paused, modified, or discontinued if the participant shows signs of excessive fatigue, discomfort, or inability to continue safely.

Adherence to the intervention will be assessed using session attendance records, including the number of sessions attended, completed, missed, or discontinued. Intervention fidelity will be monitored through direct observation by rehabilitation specialists and review of session records. These records will include session duration, treadmill speed, BWS level, exoskeleton assistance settings, rest breaks, Borg RPE scores, adverse events, and any reasons for modifying or discontinuing a session.

Outcome measures will include change in gait parameters, change in balance performance measured using the Pediatric Berg Balance Scale, and changes in neuromechanical measures associated with walking function.

The gait robot intervention is a parallel-group study. Participants in the intervention group will not be crossed over to the control treatment. Therefore, no crossover washout period is applicable.
Intervention code [1] 331853 0
Rehabilitation
Intervention code [2] 331854 0
Treatment: Devices
Description of the comparator or control
In this pilot parallel-group study, participants allocated to the comparator/control group will receive standard rehabilitation care only and will not receive P.GEAR-assisted robotic treadmill gait training.

The comparator/control intervention will consist of routine physiotherapy and rehabilitation activities provided by trained rehabilitation specialists according to the participant’s clinical needs and tolerance. These may include therapist-guided mobility exercises, stretching, strengthening, balance activities, postural control exercises, and conventional gait-related training where appropriate. No robotic exoskeleton or robot-assisted treadmill training will be used in the control group.

The duration and frequency of comparator/control sessions will be recorded during the pilot study. Where feasible, the frequency of contact will be maintained similar to the intervention group, with sessions delivered approximately three times per week over 6–8 weeks, depending on participant availability, clinical tolerance, and routine rehabilitation scheduling.

The intensity of comparator/control rehabilitation will be maintained at a low to moderate level, depending on the participant’s functional ability, clinical condition, fatigue, and therapist assessment. Intensity will be monitored through therapist observation of fatigue, discomfort, walking tolerance, and need for rest breaks. Where feasible, perceived exertion will also be recorded using an age-appropriate Borg Rating of Perceived Exertion scale.

Adherence to the comparator/control intervention will be monitored using attendance records, including the number of sessions attended, completed, missed, or discontinued. Fidelity will be monitored through direct observation by rehabilitation specialists and review of session records, including session duration, type of activities performed, rest breaks, any modifications made, and any adverse events or reasons for discontinuation.

This is a pilot parallel-group study, and participants will not be crossed over between the intervention and control groups. Therefore, a washout period is not applicable. The washout duration is 0 weeks, as no crossover treatment will be provided.
Control group
Active

Outcomes
Primary outcome [1] 342614 0
Change in Gait Recovery Index (GRI) following the P.GEAR-assisted intervention. This will be assessed as a composite primary outcome. The GRI is calculated from five gait-related domains: symmetry, stability, support/balance, efficiency/propulsion, and joint strength. These domains are derived from sensor-based measurements collected through the P.GEAR gait robot system during walking assessments. The overall GRI score will be used to assess change in gait performance from baseline to follow-up.
Timepoint [1] 342614 0
The Gait Recovery Index (GRI) will be assessed at the following timepoints relative to the P.GEAR-assisted intervention: Pre-intervention: baseline assessment before commencement of the intervention. Mid-intervention: interim assessment at week 3 of the intervention period. Post-intervention: assessment at week 6, following completion of the pilot intervention period.
Primary outcome [2] 342615 0
Change in Balance Recovery Index (BRI) following the P.GEAR-assisted intervention. This will be assessed as a composite primary outcome. The BRI is calculated from five balance-related domains: Weight Distribution Symmetry (WDS), Postural Stability (PST) based on mediolateral centre of pressure variability, Single-Limb Support Quality (SLS), Joint Torque Balance (JTB), and Dynamic Range of Motion Balance (DRB). These domains are derived from sensor-based measurements collected through the P.GEAR gait robot system during walking and balance-related assessments. The overall BRI score will be used to assess change in balance performance from baseline to follow-up.
Timepoint [2] 342615 0
The Balance Recovery Index (BRI) will be assessed at the following timepoints relative to the P.GEAR-assisted intervention: Pre-intervention: baseline assessment before commencement of the intervention. Mid-intervention: interim assessment at week 3 of the intervention period. Post-intervention: assessment at week 6, following completion of the pilot intervention period.
Primary outcome [3] 342616 0
Safety and comfort will be assessed as a composite outcome during P.GEAR-based interventions (record adverse events such as falls, pain, dizziness, discomfort)
Timepoint [3] 342616 0
Safety and comfort will be assessed throughout the P.GEAR-assisted intervention period. Adverse events, including falls, pain, dizziness, discomfort, excessive fatigue, or any other safety-related events, will be recorded during each intervention session and immediately after each session where applicable. Participant-reported fatigue, comfort, disability/functional status, and quality-of-life measures will be assessed at the following timepoints relative to the intervention: Pre-intervention: baseline assessment before commencement of the P.GEAR-assisted intervention. Mid-intervention: interim assessment at week 2 of the intervention period. Post-intervention: assessment at week 4, following completion of the pilot intervention period.
Secondary outcome [1] 451545 0
Static and Dynamic Balance will be assessed as a composite outcome using a Composite Balance Index
Timepoint [1] 451545 0
Pre, mid (week 2), and post interventions (week 4)
Secondary outcome [2] 451546 0
Usability and comfort of device will be assessed as a composite secondary outcome
Timepoint [2] 451546 0
Pre, mid (week 2), and post interventions (week 4)

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they meet all of the following criteria:

• Aged 13–18 years
• Clinical diagnosis of a motor movement disorder, including cerebral palsy, brain injury, spinal cord injury, paraplegia, muscular dystrophy, Rett syndrome, or a related condition affecting motor function
• Classified as Gross Motor Function Classification System (GMFCS) levels I–III, where applicable
• Able to follow simple verbal instructions, with or without caregiver assistance
• Medically stable and cleared by a clinician to participate in physical rehabilitation activities
• Able to participate in treadmill-based gait training with body weight support and P.GEAR assistance, as determined by the rehabilitation specialist
• Written informed consent provided by a parent or legal guardian, with participant assent obtained where appropriate
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants will be excluded if they meet any of the following criteria:

• Severe musculoskeletal deformity or joint contracture that prevents safe positioning or use of the P.GEAR system
• Uncontrolled epilepsy or seizure disorder
• Severe visual or auditory impairment that prevents the participant from following instructions safely, even with caregiver assistance
• Recent orthopaedic surgery within the previous 6 months
• Botulinum toxin injection within the previous 3 months
• Medical instability or any condition that, in the opinion of the treating clinician or rehabilitation specialist, makes participation in treadmill-based robotic gait training unsafe
• Cognitive or behavioural condition that prevents safe participation in the intervention

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 involves contacting the holder of the allocation schedule who is at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/10/2026
Actual
Date of last participant enrolment
Anticipated
23/12/2026
Actual
Date of last data collection
Anticipated
30/01/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 27324 0
Kazakhstan
State/province [1] 27324 0

Funding & Sponsors
Funding source category [1] 319792 0
Government body
Name [1] 319792 0
Ministry of Higher Education and Science
Country [1] 319792 0
Kazakhstan
Primary sponsor type
Government body
Name
Ministry of Higher Education and Science
Address
Country
Kazakhstan
Secondary sponsor category [1] 324134 0
None
Name [1] 324134 0
Address [1] 324134 0
Country [1] 324134 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318351 0
Institutional Research Ethics Committee, Nazarbayev University
Ethics committee address [1] 318351 0
Ethics committee country [1] 318351 0
Kazakhstan
Date submitted for ethics approval [1] 318351 0
21/05/2025
Approval date [1] 318351 0
30/06/2025
Ethics approval number [1] 318351 0
1081/21052025
Ethics committee name [2] 318929 0
Ethics Commission of the National Children's Rehabilitation Center, Astana, Kazakhstan
Ethics committee address [2] 318929 0
Ethics committee country [2] 318929 0
Kazakhstan
Date submitted for ethics approval [2] 318929 0
08/05/2024
Approval date [2] 318929 0
06/06/2024
Ethics approval number [2] 318929 0
IORG0012044

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

Contacts
Principal investigator
Name 143902 0
Prof Dr. Prashant Kumar Jamwal
Address 143902 0
53 Kabanbay Batyr Ave, Nazarbayev University, Astana city, Republic of Kazakhstan, 010000
Country 143902 0
Kazakhstan
Phone 143902 0
+77754586956
Fax 143902 0
Email 143902 0
[email protected]
Contact person for public queries
Name 143903 0
Dr. Prashant Kumar Jamwal
Address 143903 0
53 Kabanbay Batyr Ave, Nazarbayev University, Astana city, Republic of Kazakhstan, 010000
Country 143903 0
Kazakhstan
Phone 143903 0
+77754586956
Fax 143903 0
Email 143903 0
[email protected]
Contact person for scientific queries
Name 143904 0
Dr. Prashant Kumar Jamwal
Address 143904 0
53 Kabanbay Batyr Ave, Nazarbayev University, Astana city, Republic of Kazakhstan, 010000
Country 143904 0
Kazakhstan
Phone 143904 0
+77754586956
Fax 143904 0
Email 143904 0
[email protected]

Data sharing statement
Will the study consider sharing 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.