| CTRI Number |
CTRI/2025/06/089350 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Boosting the stronger leg: A new approach to improve walking and balance in children with hemiplegic Cerebral Palsy |
|
Scientific Title of Study
|
Effect of strengthening of unaffected lower extremity on gait and balance in ambulatory hemiplegic Cerebral Palsy –Randomized Control Trial |
| 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 Hiral Lodhiya |
| Designation |
PG Student |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no 5, MGM School of
physiotherapy Gate No. 3 N6 cidco Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8830570982 |
| Fax |
|
| Email |
hiral.lodhiya07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Palaskar |
| Designation |
Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no 5, MGM School of
physiotherapy Gate No. 3 N6 cidco Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9604487807 |
| Fax |
|
| Email |
pallavi.palaskar@mgmsop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Palaskar |
| Designation |
Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
Department of Neuro Physiotherapy no 5, MGM School of
physiotherapy Gate No. 3 N6 cidco Chh Sambhajinagar 431001,
Maharashtra, India
Aurangabad
MAHARASHTRA
431001
India
MAHARASHTRA
431001
India |
| Phone |
9604487807 |
| Fax |
|
| Email |
pallavi.palaskar@mgmsop.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of neuro physiotherapy no. 5 MGM School of Physiotherapy,N6 Cidco Aurangabad
431001, maharashtra, India |
|
|
Primary Sponsor
|
| Name |
MGM School of Physiotherapy |
| Address |
Department of neuro physiotherapy no. 5 MGM School of
Physiotherapy,N6 Cidco Aurangabad 431001, maharashtra, India |
| Type of Sponsor |
Private medical college |
|
|
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 Hiral Lodhiya |
MGM School of Physiotherapy |
MGM School of
physiotherapy, Neuro
OPD room number 5,C
building N6 Cidco
Chhatrapati
Sambhajinagar
Maharashtra 431001,
India
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA |
8830570982
hiral.lodhiya07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics committee for Research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standardized physiotherapy for affected side
|
Standardized physiotherapy for affected side
1. Strengthening Exercises
Upper Limb:
Sets/Reps: 3 sets of 10 repetitions. 5 sessions per week for 4 weeks.
Shoulder Flexion/Extension: Seated row or TheraBand exercises.
Elbow Flexion/Extension: Bicep curls and triceps extensions.
Wrist Flexion/Extension: Wrist curls.
Lower Limb:
Hip Flexion/Extension: Straight leg raises with weight cuffs
Knee Flexion/Extension: Squats.
Ankle Dorsi flexion/Plantar flexion: Ankle exercises like dorsiflexion-plantarflexion.
2. Core Stability:
Sets/Reps: 3 sets of 10 repetitions. 5 sessions per week for 4 weeks.
Bridging: Strengthening core muscles and improving pelvic stability.
3. Neuromuscular Re-education and Functional Training
Functional Task Training:
Sets/Reps: 3 sets of 10 repetitions, 5 sessions per week for 4 weeks. Engage in activities like reaching for objects and walking, focusing on symmetry and movement quality.
Gait Training: Practice walking with a focus on improving the affected side’s function and gait pattern. |
| Intervention |
Strengthening for unaffected lower extremity with conventional physiotherapy exercises |
Strengthening for unaffected lower extremity :
Sets/Reps: 3 sets of 10 repetitions. 5 sessions per week for 4 weeks.
1.Progressive Resistance Training with TheraBand
Hip Abduction: Pushing the leg outwards in standing position
Hip Extension: Pushing the leg backwards in standing position
Hip Flexion: Straight leg raises in supine position.
Knee Extension/Flexion Exercise: Dynamic quads.
Plantar flexion and Dorsi flexion: Ankle joint exercises like dorsiflexion-plantarflexion.
2. Body weight exercise:
Sets/Reps: 3 sets of 10 repetitions with 10 second hold. 5 sessions per week for 4 weeks.
Single leg weight stance on unaffected lower extremity.
3. Functional training:
Side walking towards the unaffected lower extremity.
1 set of 10 repetitions.
Step up and step down on a raised platform with unaffected leg stepping up.
1 set of 10 repetitions. 5 sessions per week for 4 weeks.
Standardized physiotherapy for affected side :
Strengthening Exercises
Core Stability
Neuromuscular Re-education and Functional Training
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children of both the genders with confirmed diagnosis of hemiplegic cerebral palsy
With ability to follow simple instructions
Able to ambulate independently without walking aid
|
|
| ExclusionCriteria |
| Details |
Previous surgical procedures to the lower extremities
Visual problems and hearing problems
Mental retardation interfering in understanding and performing the task in the exercise protocol regime and seizure disorder during activity
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pediatric Balance scale
Timed Up and Go test |
at baseline and at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gait Parameters which include stride length ,step length , cadence & walking speed |
at baseline & at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
04/07/2025 |
| 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 Yet Recruiting |
| 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
|
Aim of the study is to assess the effectiveness of strengthening of unaffected lower extremity on gait and balance in children with ambulatory Hemiplegic Cerebral Palsy. Objectives of this study are to :1.To evaluate the effect of
strengthening of unaffected lower extremity on gait performance in children
with ambulatory hemiplegic cerebral palsy.
2.To evaluate the effect of
strengthening of unaffected lower extremity on balance in children with
ambulatory hemiplegic cerebral palsy. |