| CTRI Number |
CTRI/2022/03/041428 [Registered on: 28/03/2022] Trial Registered Prospectively |
| Last Modified On: |
27/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect Of Upperlimb Pnf On Scapular Alignment And Grip Strength In Stroke Patients. |
|
Scientific Title of Study
|
Effect Of Scapular And Upper Limb Proprioceptive Neuromuscular Facilitation On Scapular Alignment, Upper Limb Function And Grip Strength In Chronic Stroke Patients - An Experimental Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kapdi Kinjalben Hirabhai |
| Designation |
Pg Student |
| Affiliation |
Spb College Of Physiotherapy. |
| Address |
Neurorehabilitation Department, Spb College Of Physiotherapy, Ugat-Bhesan Road, Jahangirabad, Morabhagal, Surat.
Surat
GUJARAT
395005
India |
| Phone |
7046193161 |
| Fax |
|
| Email |
kinjalkapdi67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Verma |
| Designation |
Assistant Professor |
| Affiliation |
Spb College Of Physiotherapy. |
| Address |
Neurorehabilitation Department, Spb College Of Physiotherapy, Ugat-Bhesan Road, Jahangirabad, Morabhagal, Surat.
Surat
GUJARAT
395005
India |
| Phone |
9638721221 |
| Fax |
|
| Email |
nidhiverma4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Verma |
| Designation |
Assistant Professor |
| Affiliation |
Spb College Of Physiotherapy. |
| Address |
Neurorehabilitation Department, Spb College Of Physiotherapy, Ugat-Bhesan Road, Jahangirabad, Morabhagal, Surat.
Surat
GUJARAT
395005
India |
| Phone |
9638721221 |
| Fax |
|
| Email |
nidhiverma4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neurorehabilitation Department, Spb College Of Physiotherapy, Ugat-Bhesan Road, Jahangirabad, Morabhagal, Surat. |
|
|
Primary Sponsor
|
| Name |
Kapdi Kinjalben Hirabhai |
| Address |
Spb College Of Physiotherapy, Ugat Bhesan Road, Jahangirabad, Morabhagal, Surat. |
| 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 |
| Dr Neha Verma |
Spb College Of Physiotherapy |
Neurorehabilitation Department, Spb College Of Physiotherapy, Ugat-Bhesan Road, Jahangirabad, Morabhagal, Surat.
Surat
GUJARAT |
9638721221
nidhiverma4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I678||Other specified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Grip Strengthening Exercise Using Spongy Ball 10 Repetitions, Active Rom Exercise Of Upper Limb Flexion, Extension, Abduction 10 Repetitions, Active Rom Exercise Of Lower Limb 10 Repetitions Passive Stretching Of Tight/Spastic Muscle Of Upperlimb And Lower Limb 3 Repetitions With 30 Second Hold, Strengthening Training Using Free Weight In Upper Limb And Lower Limb 10 Repetitions, Conventional Gait Training Walking Forward, Backward And Side Walking. |
| Intervention |
Pnf And Conventional Physiotherapy |
15 Minutes Of Scapular Pnf Anterior Elevation Posterior Depression D1 Pattern, 15 Minutes Of Upper Limb Pnf D1 Flexion D1 Extension Pattern, Agonistic Reversal Pattern Will Be Used For Pnf, 20 Minutes Of Conventional Physiotherapy. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Willingness to participate
2.Age : 40-80 years
3.Gender: Male/Female
4.Mini Mental State Examination Score 24 or more
5.First Incident of Stroke
6.Time since incidence of stroke > 6 months
7.Lateral scapular slide test- Distance of inferior angle of scapula to spinous process is > 1.5cm compare to contralateral side
8.Brunnstrom recovery stage - 3 and 4 |
|
| ExclusionCriteria |
| Details |
1.Shoulder Subluxation
2.Any other neurological condition
3.Any Visual and/or auditory dysfunction |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Fugl Meyer Assessment Upper Extremity
2.Lateral Scapular Slide Test
3.Grip Strength Measurement |
4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
03/04/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Few Studies Have Been Conducted To Find The Effect Of Scapular Pnf On Scapular Alignment And Upper Limb Function Also Some Studies Concluded That upper limb Pnf Has Positive Effect On Upper Limb Function In Stroke Individuals But There Is Very Scare Literature On Effect Of Both Upper Limb Pnf And scapular Pnf On Scapular Alignment, Grip Strength And Upper Limb Function In Chronic Stroke Patients. The Result Of This Study Will Provide The Literature Support For This Less Explored Concept Of Effect Of Both Scapular Pnf And Upper Limb Pnf On Scapular Alignment, Upper Limb Function And Grip Strength Which Would Be Beneficial To Facilitate Rehabilitation In Patients With Chronic Stroke. |