| CTRI Number |
CTRI/2025/05/086975 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| 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
|
Comparison between Nerve Gliding and Muscle Release Technique to improve leg Flexiblity and Balance in Stroke patients. |
|
Scientific Title of Study
|
Comparison between Neural Mobilization and Myofascial Release Technique on lower limb Flexibility and Balance in Stroke patients: A Randomized Clinical 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 |
Rishita Dey |
| Designation |
Post Graduate Resident |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation,College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation,College of Physiotherapy,Department of Neuro Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
8369270751 |
| Fax |
|
| Email |
rish.d02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadhana Mukhi |
| Designation |
Associate Professor, Neuro Physiotherapy Department |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation,College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation,College of Physiotherapy, Department of Neuro Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
8007011772 |
| Fax |
|
| Email |
sadhananimbhore123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadhana Mukhi |
| Designation |
Associate Professor, Neuro Physiotherapy Department |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation,College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation,College of Physiotherapy, Department of Neuro Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
8007011772 |
| Fax |
|
| Email |
sadhananimbhore123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy,Shivajinagar,Pune-411005 |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy, 11/12 Thube Park, Shvajinagar, Pune- 411005 |
| 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 |
| Rishita Dey |
Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy |
1st floor, Sancheti Institute for Orthopaedics and Rehabilitation,College of Physiotherapy, 11/12 Thube Park, Shivajinagar, Pune
Pune
MAHARASHTRA |
8369270751
rish.d02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation, College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Myofascial Release Technique |
Total intervention duration- 4 weeks, Frequency- 3 sessions per week.
Targetted muscles- Hamstring, Quadriceps, Gastrocnemius and Plantarfascia
Each targeted muscle group will receive approximately 5 minutes of application time per session. The therapy will focus on the hamstrings, gastrocnemius, quadriceps, and plantar fascia. For the hamstrings, the patient will be positioned prone with a small pillow under the ankles, and the therapist will apply deep pressure and longitudinal strokes from the ischial tuberosity to the knee. For the gastrocnemius, the patient will lie prone with feet hanging off the table to allow ankle mobility, while deep strokes and sustained pressure are applied along the calf muscles. For the quadriceps, the patient will be supine with a towel roll under the knee, and the therapist will use gliding strokes and deep sustained pressure along the anterior thigh from the hip to the knee. For the plantar fascia, the patient will be either in a long sitting position with the foot supported or prone with slight ankle dorsiflexion, while deep thumb pressure is applied along the sole, focusing on the medial arch and heel.
|
| Intervention |
Neural Mobilization |
Total intervention duration- 4 weeks, Frequency- 3 sessions per week.
Techniques Used:
Sciatic Nerve Mobilization:
Supine position with neck and trunk neutral; unaffected limb stabilized.
Straight Leg Raise combined with ankle dorsiflexion, hip adduction/internal rotation, and cervical flexion.
10 sequences per set, 3 sets per session, with 1-minute rest between sets.
Femoral Nerve Mobilization:
Side-lying position with neck and trunk neutral; unaffected limb stabilized.
Hip extension, knee flexion with ankle plantarflexion, combined with oscillatory knee and hip movements and cervical flexion.
10 sequences per set, 3 sets per session, with 1-minute rest between sets. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with CVA more than 3 months
2.Mini Mental State Examination (MMSE)score of 24 and above
3.Spasticity grade 2 or lower according to modified Ashworth scale
4.Lower limb voluntary control grade between 3-5
5.Self ambulatory patients ambulating with or without cane
|
|
| ExclusionCriteria |
| Details |
1.Unstable cardiovascular conditions like uncontrolled hypertension, peripheral vascular disease, recent MI.
2.Other neurological disorders.
3.Any musculoskeletal disorders affecting gait such as total knee or total hip arthroplasty in affected side, fracture in affected lower extremity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance (BBS)- Static and Dynamic balance |
At baseline (0 week)
Post intervention (4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Balance (TUG) |
At baseline (0 week)
Post intervention (4 weeks) |
| Flexibility ( using Goniometer) |
At baseline (0 week)
Post intervention (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)
|
30/05/2025 |
| 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 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
|
Stroke often leads to lower limb spasticity, reduced range of motion, and increased stiffness in muscles and fascia, along with altered neural mechanics due to compromised nerve mobility and blood supply. These structural changes contribute to motor impairments, decreased flexibility, poor balance, and limited mobility, especially in sub-acute and chronic stroke patients. Neural Mobilization (NM) and Myofascial Release (MFR) are therapeutic techniques aimed at improving flexibility, reducing spasticity, and enhancing balance. Although both techniques have shown positive effects individually, their comparative effectiveness in stroke rehabilitation is still unclear. This study aims to compare the effects of NM and MFR on lower limb flexibility and balance to identify the more effective intervention, ultimately aiming to improve functional outcomes and quality of life in stroke survivors. Null Hypothesis (H0):- There will be comparable effect of neural mobilization and myofascial release on lower limb flexibility and balance in sub-acute and chronic stroke patients. Alternate Hypothesis:- (H1) - Neural mobilization will be more effective on lower limb flexibility and balance as compared to Myofascial release in sub-acute and chronic stroke patients. (H2) - Myofascial release technique will be more effective than neural mobilization on lower limb flexibility and balance in sub-acute and chronic stroke patients. |