| CTRI Number |
CTRI/2025/02/080547 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| 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 of 4-week Task-Oriented Training and Scapular PNF ON upper limb function in chronic stroke: A randomized clinical trial |
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Scientific Title of Study
|
Effect OF 4 week TASK ORIENTED TRAINING VS Scapular Proprioceptive Neuromuscular Facilitation on upper limb function in individual with chronic stroke -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 |
Dili desai |
| Designation |
PG student |
| Affiliation |
S.S.agrawal institute of physiotherapy and medical care education, navsari. |
| Address |
Neuro out patient department,room no.2 ground floor, s.s agrawal institute of physiotherapy, agrawal campus,verranjali marg, devina park ,navsari
Navsari
GUJARAT
396445
India |
| Phone |
8238659948 |
| Fax |
|
| Email |
dilidesai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagruti patel |
| Designation |
Assistant professor, PG Guide and Phd scholar |
| Affiliation |
S.S.agrawal institute of physiotherapy and medical care education, navsari. |
| Address |
Neuro out patient department, room no.2 ground floor, s.s agrawal institute of physiotherapy, agrawal campus, verranjali marg, devina park ,navsari
Navsari
GUJARAT
396445
India |
| Phone |
99747661767 |
| Fax |
|
| Email |
jagukpatel57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dili desai |
| Designation |
PG student |
| Affiliation |
S.S.agrawal institute of physiotherapy and medical care education, navsari. |
| Address |
Neuro out patient department, room no.2 ground floor, s.s agrawal institute of physiotherapy, agrawal campus,verranjali marg, devina park ,navsari
Navsari
GUJARAT
396445
India |
| Phone |
8238659948 |
| Fax |
|
| Email |
dilidesai@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.S Agrawal institute of physiotherapy and medical care education, navsari, gujarat,396445 agrawal college campus, out patient department room no.2, veeranjali marg ,devina park, Navsari, Gujarat India |
|
|
Primary Sponsor
|
| Name |
Dili desai |
| Address |
26-27 Neelam park society, opposite axis bank,navsari-gandevi road, NavsarI,Gujarat,India 396445 |
| Type of Sponsor |
Other [[self]] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr shlesha vaidya |
S.S Agrawal institute of physiotherapy and medical care education |
department of physiotherapy, ground floor, agrawal college campus, veeranjali marg, devina park, Navsari, Gujarat
Navsari
GUJARAT |
9427285250
drsmvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee s.s agrawal institute of physiotherapy and medical care |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: G811||Spastic hemiplegia, (3) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Scapular PNF Therapy |
Scapular PNF therapy target scapular muscles using diagonal patterns like anterior elevation–posterior depression and posterior elevation–anterior depression. Exercises, performed lying, sitting, or standing, involve the hold-relax technique, where a tight muscle is lengthened, isometrically contracted, then further stretched. The protocol includes 3 sets of 10 repetitions over 30 minutes, with a 5-minute break between sets, repeated for 4 weeks.
Conventional therapy focuses on scapular stabilization through six motions: elevation, depression, retraction, protraction, upward rotation, and downward rotation. Exercises are done in a neutral scapular position, with smooth resistance applied by the therapist. Subjects perform 3 sets of 5 minutes per motion, maintaining isometric contraction, with a 5-minute break between exercises.
|
| Intervention |
Task Oriented Training |
Task-oriented training (TOT) involves subjects choosing 3 tasks from options like pressing switches, moving bottles of varying sizes, manipulating iron balls, or throwing a ball into a basket. These tasks are performed repeatedly, with therapist support if needed.
Conventional therapy focuses on scapular stabilization through six motions: elevation, depression, retraction, protraction, upward rotation, and downward rotation. Exercises are done in a neutral scapular position, with smooth resistance applied by the therapist. Subjects perform 3 sets of 5 minutes per motion, maintaining isometric contraction, with a 5-minute break between exercises. |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Stroke diagnosed with CT/MRI reports.
6 months post stroke.
Age group 30-65 year.
Individual with chronic stroke demonstrating lateral scapular slide test dyskinesia by
measurement of dyskinesia test.
Brunnstrom recovery grade 2 to 4.
No other neurological or orthopedic deficit. Those who understood verbal instructions and has a Mini-Mental state examination score more than 24
|
|
| ExclusionCriteria |
| Details |
Difficulty to communicate or to understand test instructions
Any musculoskeletal disorders like subluxation or dislocation of affected shoulder,
fractures in affected limb.
Visual or auditory and perceptual impairment.
Diagnosed with depression or other post-stroke psychiatric symptoms.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugel – Meyer assessment upper extremity (FMA-UE) |
baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Scapular balance angle |
Baseline & 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)
|
20/02/2025 |
| 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 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
|
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Brief Summary
|
AIM AND OBJECTIVE To investigate the effect of 4 week scapular PNF vs Task oriented training on upper limb motor function in patients with chronic stroke. To evaluate the effect of task oriented training along with conventional therapy in chronic stroke. To evaluate the effect of scapulae PNF along with conventional therapy in chronic stroke. To compare Task oriented training and scapular PNF along with conventional therapy influence upper limb function and among those with chronic stroke.
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