| CTRI Number |
CTRI/2024/05/066910 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effect of soft tissue release of upper limb muscles in abnormal movement pattern on upper limb movement and function in persons with paralysis |
|
Scientific Title of Study
|
The effect of myofascial release of muscles in abnormal synergy in upper limb on range of motion and upper extremity functioning in stroke survivors |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya Surti |
| Designation |
Postgraduate Resident |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation college of physiotherapy |
| Address |
1st floor ,Department of physiotherapy, Sancheti Institute for Orthopedics and Rehabilitation college of physiotherapy.11/12 Thube Park, Shivajinagar,
Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9326841387 |
| Fax |
|
| Email |
riyasurti111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetali Paliwal |
| Designation |
Associate Professor of neurophysiotherapy |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation college of physiotherapy |
| Address |
1st floor,Department of neurophysiotherapy ,Sancheti Institute for Orthopedics and Rehabilitation college of physiotherapy.11/12 Thube Park, Shivajinagar,
Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
8766996948 |
| Fax |
|
| Email |
chetalipaliwal07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetali Paliwal |
| Designation |
Associate Professor of neurophysiotherapy |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation college of physiotherapy |
| Address |
1st floor,Department of neurophysiotherapy, Sancheti Institute for Orthopedics and Rehabilitation college of physiotherapy.11/12 Thube Park, Shivajinagar,
Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
8766996948 |
| Fax |
|
| Email |
chetalipaliwal07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for orthopaedics and rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar,Pune 411005,Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for orthopaedics and rehabilitation college of physiotherapy |
| Address |
11/12 Thube Park, Shivajinagar,
Pune, Maharashtra – 411 005 |
| 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 |
| Riya Surti |
Sancheti Institute for orthopedics and Rehabilitation |
1st floor,
Department of Neurophysiotherapy, Sancheti Institute for Orthopedics and Rehabilitation college of physiotherapy. 11/12 Thube Park,Shivajinagar, Pune 411005.
Pune
MAHARASHTRA |
9326841387
riyasurti111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and rehabilitation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Myofascial release along with conventional therapy |
This study includes Myofascial release of muscles in abnormal synergy in upper limb along with conventional therapy for 1 hour per session, 5 days a week for 4 weeks. Pre and post assessment will include goniometric range of motion assessment and wolf motor function test |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Voluntary control of grade 3 or 4 for upper extremity and voluntary control of grade 3 or 4 for hand.
2.Subacute /Chronic stroke survivors with middle cerebral artery affection. |
|
| ExclusionCriteria |
| Details |
1.Reflex sympathetic dystrophy of affected upper extremity
2.Shoulder dislocation /subluxation of affected upper extremity
3.Recent shoulder pathology of affected upper extremity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Range of motion assessment by goniometer
2.Wolf motor function test |
Before intervention at baseline (0 weeks) and after intervention (4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2.Wolf motor function test |
Before intervention at baseline (0 weeks) and after intervention (4 weeks) |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
14/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Stroke survivors often experience impaired upper limb functioning due to presence of abnormal muscle synergies, which can limit their range of motion and daily activities. They show movements in synergy patterns that reduce upper limb range of motion which causes issues with activities of daily living like reaching activities, dressing activities, activities which require change in position from pronation to supination, like opening jars or cans, turning door knob, combing hair, feeding activities. Focusing on outcomes that directly impact stroke survivors’ lives, such as range of motion and upper extremity functioning, ensures that the research addresses issues that are important to the individuals undergoing rehabilitation thus, allowing them to regain independence in daily activities. A lot of studies have been done on improving upper extremity function, but very few studies have focused on the use of myofascial release technique to improve range of motion and upper extremity function in stroke survivors. Myofascial release is a holistic approach that considers the interconnectedness of muscles and fascia. Understanding how this technique influences abnormal synergies can provide a more comprehensive understanding of the factors influencing post-stroke recovery. |