| CTRI Number |
CTRI/2024/04/065906 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Playing instruments can help in improving hand strength in muscular dystrophy patients |
|
Scientific Title of Study
|
Music supported therapy intervention in non ambulatory Muscular Dystrophy on Hand Grip Strength, Hand Dexterity and Cognition.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Rawat |
| Designation |
Research scholar |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies
Physiotherapy department division Q block room no. QG 07 Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
8512024794 |
| Fax |
|
| Email |
anjalirawat0278@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Aggarwal |
| Designation |
Assistant professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies
Physiotherapy department division Q block room no. QT 05 Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9999597755 |
| Fax |
|
| Email |
divyaaggarwal.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Aggarwal |
| Designation |
Assistant professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies
Physiotherapy department division Q block room no. QT 05 Faridabad
HARYANA
121004
India |
| Phone |
9999597755 |
| Fax |
|
| Email |
divyaaggarwal.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute of Research and Studies manav rachna campus Rd, Gadakhor Basti Village, sector 43,faridabad,haryana,pincode-121004 india |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
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 Divya Aggarwal |
Manav Rachna International Institute of Research and Studies |
Department of physiotherapy neurology physiotherapy lab Q - block room number-QG 07 , MRIIRS sector 43 Aravalli Hills Surajkund road Faridabad
Faridabad
HARYANA |
8512024794
anjalirawat0278@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee , school of allied health sciences, Manav Rachna International Institute of research and studies, faridabad , haryana india |
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 |
control group |
1 Exercise based on Thera putty 30 minutes
- Mass wrist and finger movements 1-3 sets 10 repetitions,
- Isolated thumb and finger movements 1-3 sets 3 repetitions
Complexity can increase by further increase in repetitions and sets.
2 General mobility and strengthening exercises of upper limb and lower limb 30 min
- Stretching of calf and hamstring muscles
- Passive and active assisted movements of upper limb and lower limb 1-3 sets 10 repetitions
- Strengthening exercises of upper limb, lower limb, neck and trunk muscles 1-2 sets 10 repetitions
|
| Intervention |
music supported hand training |
1 Music supported training-group received 30 minutes 15 min of piano and 15 min of drum stick of instrumented training with stepwise increase of complexity.
2 General mobility and strengthening exercises of upper limb and lower limb 30 min
-Stretching of calf and hamstring muscles
- Passive and active assisted movements of upper limb and lower limb 1-3 sets 10 repetitions
- Strengthening exercises of upper limb, lower limb, neck and trunk muscles 1-2 sets 10 repetitions
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Both male and female diagnosed with muscular
dystrophy .
2 Non ambulatory patients .
3 Wrist and hand strength of grade 3 (MMT).
4 Able to perform simple motor commands . |
|
| ExclusionCriteria |
| Details |
1 Strength in wrist and hand less than MMT grade 3.
2 Received any music supported training before .
3 Any hearing and visual defect .
4 Unable to communicate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
- hand grip strength
- cognition
- manual dexterity |
Pre interventional assessment and post interventional assessment will be taken of the outcomes measures between the time period of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| -functional independence measures |
Pre interventional assessment and post interventional assessment will be taken of the outcomes measures between the time period of 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/04/2024 |
| 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="3"
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
|
-To check the effect of music supported hand training on muscular dystrophy in hand grip strength, manual dexterity& cognition.
- subjects will be evaluated for the inclusion and exclusion criteria and randomly divided into two groups. Music supported group and control group. -Both groups received rehabilitation program that consisted of 1-hour sessions of physiotherapy a day (5 days per week, 5 hours in total per week). -Music supported training group received 30 minutes (15 min of piano & 15 min of drum stick) of instrumented training , General mobility and strengthening exercises of upper limb and lower limb (30 min) . -control group performed exercises based on Thera putty (30 minutes) and General mobility and strengthening exercises of upper limb and lower limb (30 min)
|