| CTRI Number |
CTRI/2026/02/103630 [Registered on: 11/02/2026] 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
|
Effect of Task-Oriented Functional Training with Balance Training Compared to Conventional Physiotherapy on Balance, Mobility, and Motor Function in Patients with Muscular Dystrophy |
|
Scientific Title of Study
|
Comparative Effects of Task- Oriented Functional Training Combined with Balance Training Versus Conventional Physiotherapy on Balance, Mobility and Gross Motor Function in Patients with Muscular Dystrophy: A Randomized Controlled 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 |
Anugrah Lal |
| Designation |
Postgraduate Student |
| 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
121004
India |
| Phone |
8447568515 |
| Fax |
|
| Email |
anugrahprince2@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
121004
India |
| Phone |
8800125047 |
| Fax |
|
| Email |
Sunita.fas@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anugrah Lal |
| Designation |
Postgraduate Student |
| 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
121004
India |
| Phone |
8447568515 |
| Fax |
|
| Email |
anugrahprince2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute of Research and Studies Manav Rachna International Institute of Research and Studies, Sector-43, Aravalli Hills, Faridabad-121004, Haryana, India |
|
|
Primary Sponsor
|
| Name |
Anugrah Lal |
| Address |
Manav Rachna International Institute of Research and Studies, Sector-43, Aravalli Hills, Faridabad-121004, Haryana, India |
| 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 Anugrah Lal |
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 |
8447568515
anugrahprince2@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 |
Controlled Group (Conventional Physiotherapy) |
This group will receive the regular conventional physiotherapy for 4 weeks. Including gentle stretching of calf muscles, hamstring muscles, and quadriceps muscle groups along with active assisted range of motion exercises for all the joints of the upper limbs and lower limbs.
( TOTAL DURATION OF INTERVENTION: 4 sessions/ week for 4 Weeks.
Each session timing : 40-50 mins ) |
| Intervention |
Experimental group (task-oriented functional training combined with Balance Training) |
The TOFT and BT intervention program was planned progressively over four weeks, focusing on balance, mobility, proprioception, and gross motor function. In week 1, TOFT included functional training such as seated and standing reaching for objects at varying heights (2 sets of 8–10 repetitions, approximately 12 minutes) to improve balance, along with stepping over low cones or lines (2 sets of 8–10 repetitions, around 13 minutes) to enhance mobility and gross motor skills. The BT component during week 1 consisted of balancing exercises on a foam pad or wobble board with eyes open for 10 minutes, followed by proprioceptive training through textured surface walking for 5 minutes. In week 2, functional training was progressed by adding dynamic elements such as reaching while shifting weight (2 sets of 8–10 repetitions, about 12 minutes), and obstacle height was slightly increased during stepping exercises (2 sets of 8–10 repetitions, around 13 minutes). Balance training continued with foam pad or wobble board exercises with eyes open for 10 minutes, and proprioceptive training again included textured surface walking for 5 minutes. In week 3, TOFT emphasized timed walking tasks involving walking to a target with turns and stops (3 sets of 5–6 minutes, approximately 12 minutes) and transfer practice through sit-to-stand exercises with support (3 sets of 8–10 repetitions, around 13 minutes). The BT component in week 3 included balancing on a foam pad or wobble board with eyes closed for 10 minutes and proprioceptive training through textured surface walking while carrying weighted objects for 5 minutes. In week 4, timed walking tasks were progressed by incorporating dual-task activities such as carrying objects (3 sets of 6 minutes, approximately 13 minutes), and transfers practice involved unsupported sit-to-stand variations to improve gross motor endurance (3 sets of 10 repetitions, around 12 minutes). Balance training continued with eyes-closed exercises on a foam pad or wobble board for 10 minutes, along with proprioceptive training using textured surface walking while carrying weighted objects for 5 minutes.
( TOTAL DURATION OF INTERVENTION: 4 sessions/ week for 4 Weeks.
Each session timing : 40-50 mins ) |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both the genders with confirmed diagnosis of muscular dystrophy
Ambulatory or partially ambulatory status, defined by Vignos scale scores of 3-5.
Able to understand simple instructions and can be followed.
Age group (6-30) |
|
| ExclusionCriteria |
| Details |
Severe cognitive impairment.
Recent surgery (which is done within 6 months) or ongoing acute medical conditions (e.g., fractures, infections).
Severe contractures or advanced disease stage (FSHD type) limiting functional training. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1- Berg Balance Scale
2- Vignos functional Rating Scale
3- Gross Motor Function Measurement-88 scale (Domain-E) |
All primary outcomes are assessed at baseline (pre-intervention) and after 4 weeks (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)
|
24/02/2026 |
| 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 intervention program involved a structured four-week rehabilitation approach combining task-oriented functional training with balance training to improve balance mobility and gross motor function in individuals with muscular dystrophy. The program progressed gradually from basic functional activities such as reaching and stepping over low obstacles to more challenging tasks, including dynamic weight shifting, timed walking, dual-task activities, and unsupported transfers. Balance and proprioceptive training were integrated throughout using foam surfaces, wobble boards, textured walking surfaces, and controlled sensory challenges with eyes open and closed. The overall focus was on practicing meaningful functional movements in a safe and progressive manner to enhance postural control, movement efficiency, and functional independence while minimizing fatigue and risk of injury. |