| CTRI Number |
CTRI/2026/02/104050 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| 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
|
Improving Balance and Walking Ability in Muscular Dystrophy: Stretching vs. Myofascial Release |
|
Scientific Title of Study
|
COMPARATIVE EFFECTS OF MYOFASCIAL RELEASE VS STRETCHING OF PLANTAR FASCIA ON BALANCE AND SPATIAL PARAMETERS OF GAIT IN AMBULATORY MUSCULAR DYSTROPHY INDIVIDUALS: A 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 |
Devjeet Mukherjee |
| Designation |
Principal investigator , PG scholar |
| Affiliation |
Manav Rachna International Institute of research and studies |
| Address |
QG-08, Q block, Outpatient Department, Department of Physiotherapy, School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies, Faridabad
Faridabad
HARYANA
121010
India |
| Phone |
9818937164 |
| Fax |
|
| Email |
devjeetmukherjee9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita kumari |
| Designation |
Assistant professor |
| Affiliation |
Manav Rachna International Institute of research and studies |
| Address |
QG-08, Q block, Outpatient Department, Department of Physiotherapy, School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies, Faridabad
Faridabad
HARYANA
121010
India |
| Phone |
8800125047 |
| Fax |
|
| Email |
sunita.fas@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Devjeet Mukherjee |
| Designation |
Principal investigator , PG scholar |
| Affiliation |
Manav Rachna International Institute of research and studies |
| Address |
QG-08, Q block, Outpatient Department, Department of Physiotherapy, School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies, Faridabad
Faridabad
HARYANA
121010
India |
| Phone |
9818937164 |
| Fax |
|
| Email |
devjeetmukherjee9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute of research and studies,Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121010 |
|
|
Primary Sponsor
|
| Name |
Devjeet Mukherjee |
| Address |
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121010 |
| 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 Devjeet Mukherjee |
Manav Rachna International Institute of Research and Studies |
QG-08, Q block, Outpatient Department, Department of Physiotherapy, School of Allied Health Sciences,Manav Rachna International Institute of research and studies , Faridabad
Faridabad
HARYANA |
9818937164
devjeetmukherjee9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Ethical Committee (DEC), Department of Physiotherapy, School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies (MRIIRS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G710||Muscular dystrophy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Myofascial release group |
Myofascial release group
Patient position: Prone, with feet hanging off the edge of the table to allow for easy dorsiflexion.
Therapist position: Sitting on a stool at the end of the table.
Technique used: The therapist used the knuckles to engage the soft tissue just anterior to the calcaneus, applying a line of tension in an anterior direction. The technique was progressed toward the ball of the foot with combined toe flexion and extension movements from the patient’s side.
(TOTAL DURATION OF INTERVENTION: 5 minutes 1 set each 2 session in a week, for 4 weeks in total.)
Along with regular physiotherapy |
| Intervention |
Stretching group |
Stretching of plantar fascia
Patient position: Sitting comfortably while performing the plantar fascia stretching with the treating leg crossed over the opposite leg.
Therapist position: Sitting on a stool at the end of the table.
Technique used: The therapist placed the fingers across the base of the toes on the plantar aspect of the foot and gently pulled the toes back toward the shin until a stretch was felt in the arch of the foot.
(TOTAL DURATION OF INTERVENTION : 20 seconds hold 8 repetition 2 sets / 2 session in a week, for 4 weeks in total.) regular physiotherapy |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed diagnosis of Muscular dystrophy.
Both male and female
AGE GROUP ( 9 to 35 years)
Able to ambulate by using VIGNOS scale up to grade 4.
Individuals with Foot Posture Index (FPI) scores ranging from (–4 to +5). |
|
| ExclusionCriteria |
| Details |
No recent lower limb surgery.
No foot or skin issues that contradicting manual therapy.
Allergy and intolerance to gels that used during therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg balance scale
Spatial parameters (stride length, Normalized stride length, step width ,Ratio of Step Width to Normalized Stride Length) |
Baseline (pre intervention) to end of post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
23/02/2026 |
| 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 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
|
This study is a randomized controlled trial designed to compare the effects of myofascial release and stretching of the plantar fascia on balance and spatial parameters of gait in ambulatory individuals with muscular dystrophy. A total of 38 participants will be recruited and randomly allocated into two groups. One group will receive stretching of the plantar fascia and the other group will receive myofascial release of the plantar fascia. Both interventions will be administered for a duration of four weeks. Balance will be assessed using the Berg Balance Scale and spatial parameters of gait such as stride length and normalized stride length will be evaluated at baseline and at the end of the intervention period. The results of the study will help in determining the more effective intervention for improving balance and gait parameters in ambulatory muscular dystrophy individuals. |