| CTRI Number |
CTRI/2024/07/070123 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| 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
|
A clinical trial to study the effects of scapular PNF and scapular stabilization exercises in stroke patients having problem in scapular orientation and functions |
|
Scientific Title of Study
|
Comparative efficacy between Scapular Proprioceptive Neuromuscular Facilitation and Scapular Stabilization exercises on scapular dyskinesia of hemiplegic shoulder: 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 |
Sourav Jana |
| Designation |
Post Graduate Student |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room Number 117, Department of Physiotherapy National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India
North Twentyfour Parganas WEST BENGAL 700090 India |
| Phone |
9002423312 |
| Fax |
|
| Email |
janasourav141@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sourov Saha |
| Designation |
Senior Physiotherapist cum Junior Lecturer |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room Number 117, Department of Physiotherapy National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India
North Twentyfour Parganas WEST BENGAL 700090 India |
| Phone |
9433845886 |
| Fax |
|
| Email |
sourov.saha.pht@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sourov Saha |
| Designation |
Senior Physiotherapist cum Junior Lecturer |
| Affiliation |
National Institute for Locomotor Disabilities (Divyangjan) |
| Address |
Room Number 117, Department of Physiotherapy National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata
North Twentyfour Parganas
WEST BENGAL
700090
India
WEST BENGAL 700090 India |
| Phone |
9433845886 |
| Fax |
|
| Email |
sourov.saha.pht@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata North Twentyfour Parganas WEST BENGAL 700090 India |
|
|
Primary Sponsor
|
| Name |
Sourav Jana |
| Address |
National Institute for Locomotor Disabilities (Divyangjan) BT Road, Bonhooghly, Kolkata, West Bengal, Pin - 700090 |
| 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 |
| Sourav Jana |
National Institute for Locomotor Disabilities (Divyangjan) |
Room Number 117, Department of Physiotherapy, National Institute for Locomotor Disabilities (Divyangjan), BT Road, Bonhooghly, Kolkata West Bengal Pin Code - 700090
North Twentyfour Parganas
WEST BENGAL North Twentyfour Parganas WEST BENGAL |
9002423312
janasourav141@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, NATIONAL INSTITUTE FOR LOCOMOTOR DISABILITIES (DIVYANGJAN) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Scapular Proprioceptive Neuromuscular Facilitation |
This group will receive scapular proprioceptive neuromuscular facilitation exercises for 30 minutes. Rhythmic Initiation will be applied for 10 repetitions for each diagonal pattern and then Repeated Contraction for 10 repetitions for each diagonal pattern and rest for 2 minutes in between the two exercises. Supervised exercise program will be continued for 30 minutes per session for 16 sessions. |
| Comparator Agent |
Scapular Stabilization Exercises |
This group will receive scapular stabilization exercises for 30 minutes (2 set of 10 repetitions for each exercise and rest for 2minutes in between 2 sets) and supervised exercise program for 30 minutes per session for 16 sessions. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Both male and female patients aged between 40 – 70 years.
2. Presence of scapular dyskinesia according to Kibler’s Lateral Scapular Slide Test.
3. Diagnosed as first ever stroke.
4. Duration of 3 months to 2 years after stroke.
5. According to Modified Ashworth Scale, spasticity grade-1 to grade- 2 in upper extremity.
6. Brunnstorm upper limb recovery stage 3 to 5.
7. Patients with Mini Mental State examination (MMSE) Score ≥ 24.
8. Patient is able to sit independently without support.
|
|
| ExclusionCriteria |
| Details |
1. Patient having shoulder pathology (supraspinatus or biceps tendinitis, frozen shoulder, fibromyalgia, and shoulder joint arthritis etc.).
2. Shoulder subluxation more than grade 2 in Fingerbreadth Palpation Methods.
3. Previous shoulder injury causing malposition of shoulder or surgery around arm and shoulder girdle.
4. According to Numeric pain rating scale (NPRS) severe shoulder pain ≥ 7.
5. Patients with hemineglect.
6. Patient with uncontrolled hypertension, cardio-respiratory disease.
7. Other neurological disorders affecting upper extremity like Parkinson’s Disease, Peripheral Neuropathies etc.
8. Patients with sensory and global aphasia. 9. Non-cooperative patients and unwilling to participate. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Scapular orientation by- Kibler’s Lateral Scapular Slide Test
2. Upper extremity functions by- Fugl-Meyer Assessment Upper Extremity (FMA UE) |
2 times – on day 0 and after 4 weeks of intervention.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
25/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/04/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
PURPOSE OF THE STUDY:
Scapular dyskinesia is a major obstacle in improvement of shoulder function in hemiplegic shoulder. Studies have shown that proprioceptive neuromuscular facilitation techniques can improve scapular orientation and upper extremity function. Scapular stabilization exercises have also been shown to significantly improve scapular orientation and upper extremity functions after stroke. However, to the best of our knowledge, there is paucity of studies investigating the comparative efficacy between scapular proprioceptive neuromuscular facilitation and scapular stabilization exercises on scapular dyskinesia of hemiplegic shoulder. Therefore, the purpose of the study is to compare the efficacy between scapular proprioceptive neuromuscular facilitation and scapular stabilization exercises on scapular dyskinesia of hemiplegic shoulder after stroke.
To find out the comparative efficacy between scapular proprioceptive neuromuscular facilitation and scapular stabilization exercises on scapular dyskinesia of hemiplegic shoulder.
1. To find out the efficacy of scapular proprioceptive neuromuscular facilitation on scapular dyskinesia of hemiplegic shoulder.
2. To find out the efficacy of scapular stabilization exercises on scapular dyskinesia of hemiplegic shoulder. 3. To compare the efficacy between scapular proprioceptive neuromuscular facilitation and scapular stabilization exercises on scapular dyskinesia of hemiplegic shoulder.
HYPOTHESES:
NULL HYPOTHESIS: There is no statistically significant difference between the efficacy of scapular proprioceptive neuromuscular facilitation and scapular stabilization exercises on scapular dyskinesia of hemiplegic shoulder.
ALTERNATIVE HYPOTHESIS: There is statistically significant difference between the efficacy of scapular proprioceptive neuromuscular facilitation and scapular stabilization exercises on scapular dyskinesia of hemiplegic shoulder.
PROCEDURE:
Institutional Ethical Committee (IEC) approval will be obtained before commencement of the study. Hemiplegic stroke patients referred from the NILD Assessment Clinic to the Department of Physiotherapy will be approached with the study proposal. Patients meeting the exclusion criteria will not be included. 32 hemiplegic stroke patients will be included after evaluation and screening according to the inclusion and exclusion criteria. The purpose of study will be explained to the patients in the language they can communicate easily. Written informed consent in their preferred language will be obtained from patients who will agree to participate. Patients will be divided into two groups using block randomization method by computer-generated random blocks.
Demographic data and outcome measures including Kibler’s Lateral Scapular Slide Test for scapular orientation and Fugl-Meyer Upper Extremity Assessment for upper extremity function will be collected from all patients prior to intervention and post intervention.
All patients in Group A will receive scapular proprioceptive neuromuscular facilitation (PNF) along with supervised exercise program and home exercise program. Scapular PNF will be applied in two diagonal patterns that are Anterior Elevation and Posterior Depression and Posterior Elevation and Anterior Depression. The therapist will apply Rhythmic Initiation and Repeated Contraction Facilitation technique on the hemiplegic shoulder for all movement patterns to facilitate. Diagonal patterns will be applied for 20 repetitions, 10 repetitions of Rhythmic Initiation and 10 repetitions of Repeated Contraction Facilitation techniques will be applied with 2 minutes break in between the two techniques. All patients in Group B will receive scapular stabilization exercises along with supervised exercise program and home exercise program. Scapular Stabilization Exercises in form of Dynamic Closed-Chain (Weight-Bearing) stabilization exercises along with Open chain strengthening exercises of the scapula stabilizer will be applied on the hemiplegic shoulder of the patient either in standing/ sitting, prone lying or in quadruped position. All patients, in both Group A and Group B will receive 16 sessions (4 sessions per week for 4 weeks). The patients in both the groups will be suggested to follow the home exercise program. Both groups will continue to use prescribed medication along with physiotherapy. |