| CTRI Number |
CTRI/2025/11/098171 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Added effect of robotic assisted mobility trainer on range of motion of knee joint and strength of knee muscles in cerebral palsy children |
|
Scientific Title of Study
|
Added effect of robotic assisted mobility trainer on range of motion of knee joint and strength of knee muscles in cerebral palsy children: An Experimental 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 |
Dr. Dipti Patil (PT) |
| Designation |
Senior consultant and Founder |
| Affiliation |
Aarrosh Aquatherapy, Physiotherapy, Rehabilitation and Research Centre |
| Address |
268/285, Mhada Layout, Gorai-1, Gorai road, RSC 1/A, Near Ganesh temple, Borivali (W), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400092
India |
| Phone |
9892500123 |
| Fax |
|
| Email |
kh.deepti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shreya Satam (PT) |
| Designation |
Senior consultant |
| Affiliation |
Aarrosh Aquatherapy, Physiotherapy, Rehabilitation and Research Centre |
| Address |
268/285, Mhada Layout, Gorai-1, Gorai road, RSC 1/A, Near Ganesh temple, Borivali (W), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400092
India |
| Phone |
9892500123 |
| Fax |
|
| Email |
shreyasatam7676@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shreya Satam (PT) |
| Designation |
Senior consultant |
| Affiliation |
Aarrosh Aquatherapy, Physiotherapy, Rehabilitation and Research Centre |
| Address |
268/285, Mhada Layout, Gorai-1, Gorai road, RSC 1/A, Near Ganesh temple, Borivali (W), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400092
India |
| Phone |
9892500123 |
| Fax |
|
| Email |
shreyasatam7676@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Dipti Patil PT |
| Address |
268/285, Mhada Layout, Gorai-1, Gorai road, RSC 1/A, Near Ganesh temple, Borivali (W), Mumbai-400092 |
| Type of Sponsor |
Other [Self] |
|
|
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 Dipti Patil PT |
Aarrosh |
Aarrosh OPD, 268/285, Mhada Layout, Gorai-1, Gorai road, RSC 1/A, Near Ganesh temple, Borivali (W), Mumbai-400092
Mumbai (Suburban)
MAHARASHTRA |
09892500123
kh.deepti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Aarrosh Aquatherapy, Physiotherapy, Rehabilitation and Research centre |
No Objection Certificate |
| K J Somaiya College of Physiotherapy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G80||Cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
Conventional physiotherapy for 45 mins will be provide during the 2 months period. |
| Intervention |
Robotic assisted mobility training |
The passive mode of the Robotic assisted mobility trainer will be used for the first 5 sessions and the active-assisted
mode will be used for 6-10 sessions, one session will be of approximately 30 mins. The flexion- extension movement of the knee joint of both
the legs will be performed using the device. 3 sets of 10 repetitions with 1 min rest
between each set will be performed. The range and strength will be set and progressed
according to individual assessment.
The duration of intervention will be for 2 months (1-2 sessions per week). |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with cerebral palsy
GMFCS level 1-3
Having enough cognitive ability to participate in the training protocol |
|
| ExclusionCriteria |
| Details |
Uncontrolled seizures
Recent orthopaedic surgeries
Any cardio-respiratory complications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Range of motion of knee joint
Strength of knee joint muscles |
At baseline, 1 month and 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
10/01/2026 |
| 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="1"
Months="0"
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
|
In children with CP, it is challenging to elicit cooperation and motivate them to exercise the
impaired joints enthusiastically. The intensity of the therapy should be considered so as to
challenge the children but at the same time not to frustrate them. Very few protocols and
available devices take these issues into consideration. Furthermore, there is insufficient study
regarding effectiveness of robotic assisted mobility trainers in cerebral palsy children.
Therefore, this study aims to investigate the effect of robotic assisted mobility trainer on
strength and range of motion of knee joint in cerebral palsy children. Its a pre-post interventional type of study with a control group, where the interventional group will receive a robotic assisted mobility training along with conventional physiotherapy while the control group will receive only conventional physiotherapy. The intervention will be provided for 10 sessions across 2 months period. The children will be assessed for their knee joint ranges and their knee joint muscle strength, at baseline, post 5 weeks and post 10 weeks. |