| CTRI Number |
CTRI/2026/03/105297 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A New Powered Brace to Improve Walking in Children with Cerebral Palsy. |
|
Scientific Title of Study
|
Efficacy of a novel powered ankle foot orthosis for spastic hemiplegic Cerebral Palsy: A feasibility study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abdul Raheel |
| Designation |
Post graduate |
| Affiliation |
RV College of Physiotherapy |
| Address |
Department of pediatric physiotherapy, ground floor-G7, 9th Main Rd, 4th T Block East, 4th Block, Jayanagar, Bengaluru, Karnataka
Bangalore
KARNATAKA
560011
India |
| Phone |
9742028529 |
| Fax |
|
| Email |
abdulraheelpt1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pallavi B Wajapey |
| Designation |
Associate Professor |
| Affiliation |
RV College of Physiotherapy |
| Address |
Department of pediatric physiotherapy, ground floor-G7, 9th Main Rd, 4th T Block East, 4th Block, Jayanagar, Bengaluru, Karnataka
Bangalore
KARNATAKA
560011
India |
| Phone |
9902351697 |
| Fax |
|
| Email |
pallaviwajapey.rvcp@rvei.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Abdul Raheel |
| Designation |
Post graduate |
| Affiliation |
RV College of Physiotherapy |
| Address |
Department of pediatric physiotherapy, ground floor-G7, 9th Main Rd, 4th T Block East, 4th Block, Jayanagar, Bengaluru, Karnataka
Bangalore
KARNATAKA
560011
India |
| Phone |
9742028529 |
| Fax |
|
| Email |
abdulraheelpt1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RV College of Physiotherpy |
| Address |
No.CA 2, 83-3, 9th Main Rd, 4th T Block East, 4th Block, Jayanagar, Bengaluru, Karnataka 560011 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pallavi B Wajapey |
RV College of Physiotherapy |
No.CA 2, 83-3, 9th Main Rd, 4th T Block East, 4th Block, Jayanagar, Bengaluru, Karnataka 560011
Bangalore
KARNATAKA |
9902351697
pallaviwajapey.rvcp@rvei.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RV College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Powered Ankle Foot orthosis |
A powered Ankle Foot Orthosis will be worn by the child to check the gait parameters |
| Comparator Agent |
rigid ankle foot orthosis |
child make to wear rigid ankle foot orthosis and check the gait parameters |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed case of spastic hemiplegic CP
2. Winters classification type 1 and 2
3. Able to understand and follow commands
4. Passive dorsiflexion ROM of ankle at 90degrees
5. Parents willing to give consent for the study |
|
| ExclusionCriteria |
| Details |
1. Cognitively impaired child
2. Vision impairement
3. Other neurological involvement
4. Severe mediolateral instability/deformity at the ankle
5. Botolinum toxin or surgical intervention in the past 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Spatial and temporal parameters of gait
2. Foot Pressure distribution |
at baseline and at one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post Study System Usabilityb Questionnaire |
at one week |
|
|
Target Sample Size
|
Total Sample Size="1"
Sample Size from India="1"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ankle Foot Orthoses (AFOs) are essential assistive devices for managing spasticity and improving mobility in individuals with cerebral palsy (CP). These orthoses provide stability and support to the foot and ankle, assisting with proper foot positioning to enhance gait mechanics, reduce fall risk, and prevent complications such as contractures.Passive AFOs, in particular, limit ankle motion, which may contribute to muscle disuse atrophy and adverse neural adaptations, ultimately reducing overall mobility and muscle strength. Their restrictive nature also inhibits sensory feedback, which is crucial for motor learning and control, thereby complicating rehabilitation efforts. Additionally, the rigidity of passive AFOs limits their adaptability to individual gait patterns and foot deformities, reducing their effectiveness in personalized rehabilitation strategies.With advancements in technology, powered and sensor-integrated AFOs have emerged as a promising solution. These modern AFOs incorporate actuators, sensors, and adaptive control systems to provide real-time assistance, allowing for controlled dorsiflexion and plantarflexion that aligns with natural gait patterns. By dynamically adjusting to the user’s movement, these advanced AFOs can reduce muscle atrophy, improve neuromuscular adaptations, and enhance functional mobility compared to rigid passive orthoses. Additionally, powered AFOs improve sensory feedback and proprioception, essential for motor control and rehabilitation, thereby offering a more personalized and effective approach to mobility assistance. The integration of artificial intelligence and robotics in AFO design further enhances adaptability, making these devices more responsive to the unique needs of patients. |