| CTRI Number |
CTRI/2024/11/076763 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparative effect of scapular proprioceptive neuromuscular facilitation and mirror therapy to improve shoulder voluntary control in subacute and chronic stroke patients
|
|
Scientific Title of Study
|
To compare the effectiveness of scapular proprioceptive neuromuscular facilitation and mirror therapy to improve shoulder voluntary control in subacute and chronic stroke patient-an interventional study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apeksha Shaparia |
| Designation |
PG Physiotherapy student |
| Affiliation |
Government physiotherapy college, Jamngar |
| Address |
Neuro rehabilitation department OPD, Government physiotherapy college, jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9773264302 |
| Fax |
|
| Email |
apekshashaparia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karishma jagad |
| Designation |
Senior lecturer of government physiotherapy college, jamnagar |
| Affiliation |
overnment physiotherapy college, Jamngar |
| Address |
Neuro rehabilitation department OPD, Government physiotherapy college, jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9374141991 |
| Fax |
|
| Email |
karishma.jagad@gptcjam.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apeksha Shaparia |
| Designation |
PG Physiotherapy student |
| Affiliation |
Government physiotherapy college, Jamngar |
| Address |
Neuro rehabilitation department OPD, Government physiotherapy college, jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9773264302 |
| Fax |
|
| Email |
apekshashaparia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neuro rehabilitation outpatient physiotherapy center of Government physiotherapy college, jamnagar,361008,india |
|
|
Primary Sponsor
|
| Name |
Government Physiotherapy College Jamnagar |
| Address |
Neuro rehabilitation department OPD, Government physiotherapy college, jamnagar
Jamnagar
GUJARAT
361008
India |
| Type of Sponsor |
Government 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 |
| Dr Apeksha Shaparia |
Government physiotherapy college, Jamnagar |
Neuro rehabilitation department OPD, Government physiotherapy college, jamnagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT |
9773264302
apekshashaparia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee shree M.P. shah Govt. medical college and G.G. Govt. Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
conventional physical therapy |
stretching, active-assisted exercise, strengthening exercise, balance and co-ordination exercise, fine motor activities, gait training for 4 sessions per weeks for 3weeks |
| Comparator Agent |
conventional physical therapy + mirror therapy |
stretching, active-assisted exercise, strengthening exercise, balance and co-ordination exercise, fine motor activities, gait training, mirror therapy 4 sessions per weeks for 3weeks |
| Comparator Agent |
conventional physical therapy + scapular PNF |
stretching, active-assisted exercise, strengthening exercise, balance and co-ordination exercise, fine motor activities, gait training, scapular PNF 4 sessions per weeks for 3weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subject willing to participate in the study,
Able to understand and follow the verbal instruction,
Subject with subacute and chronic stroke,
Reduced voluntary control of shoulder,
Both male and female are included
|
|
| ExclusionCriteria |
| Details |
Subject with shoulder pathology(fracture etc...)
Subject with acute stroke
Subject with shoulder subluxation
Subject having any other musculoskeletal and neurological condition
Inability to follow and understand the verbal commands |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FUGL-MEYER ASSESMENT- UPPER EXTRIMITY SCALE |
Baseline( on 1st day)and after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/12/2024 |
| 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="0"
Months="8"
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
|
|
Brief Summary
|
Data will be collecting from the patients coming to Government physiotherapy college-OPD, Jamnagar. From this data I will extract the number of patients which are coming for the treatment of stroke. Patients who fit selection criteria will be selected. consent will be taken from the patients and one group of patients with stroke will be treated with either scapular PNF along with conventional therapy or mirror therapy along with convention therapy for 3 weeks. Before and after intervention Fugl Meyer assessment upper extremity scale will be measured. Data will be collected over a period of 8 months. |