| CTRI Number |
CTRI/2020/11/028909 [Registered on: 04/11/2020] Trial Registered Prospectively |
| Last Modified On: |
05/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF MOTOR IMAGERY COMBINED MIRROR THERAPY EXERCISES ON UPPER ARM FUNCTION IN ACUTE STROKE |
|
Scientific Title of Study
|
EFFECT OF MOTOR IMAGERY COMBINED WITH MIRROR THERAPY ON UPPER EXTREMITY FUNCTIONAL RECOVERY IN ACUTE STROKE-A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sajna S V |
| Designation |
Master Of Physiotherapy (MPT) Student |
| Affiliation |
Nitte Institute Of Physiotherapy |
| Address |
Ground Floor, Room No.20, Nitte Institute Of Physiotherapy, K.S Hedge Medical Sciences Complexes, Nitte Deemed To Be University, Derlakatte, Mangalore – Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6362892902 |
| Fax |
|
| Email |
sajna26.ss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purusotham Chippala |
| Designation |
Professor |
| Affiliation |
Nitte Institute Of Physiotherapy |
| Address |
Ground Floor, Room No.20, Nitte Institute Of Physiotherapy, K.S Hedge Medical Sciences Complexes, Nitte Deemed To Be University, Derlakatte, Mangalore – Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9916460185 |
| Fax |
|
| Email |
chippala1979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sajna S V |
| Designation |
Master Of Physiotherapy (MPT) Student |
| Affiliation |
Nitte Institute Of Physiotherapy |
| Address |
Ground Floor, Room No.20, Nitte Institute Of Physiotherapy, K.S Hedge Medical Sciences Complexes, Nitte Deemed To Be University, Derlakatte, Mangalore – Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6362892902 |
| Fax |
|
| Email |
sajna26.ss@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PHYSIOTHERAPY KS HEGDE HOSPITAL DERLAKATTE,MANGALORE,575018 |
|
|
Primary Sponsor
|
| Name |
NITTE DEEMED TO BE UNIVERSITY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY KS HEGDE HOSPITAL DERLAKATTE,MANGALORE,575018 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sajna S V |
Justice K.S Hedge Charitable Hospital,Mangaluru |
Department Of Medicine, 4th Floor, Justice K.S Hedge Charitable Hospital, Mangaluru
Dakshina Kannada
KARNATAKA |
6362892902
sajna26.ss@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: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL THERAPY |
BILATERAL UPPER LIMB STRETCHING,POSITIONING,
ROLLING,BRIDGING ,BEDSIDE SITTING,STANDING AND WALKING FOR 40 MINUTES FOR 10 DAYS
|
| Intervention |
MOTOR IMAGERY COMBINED WITH MIRROR THERAPY
CONVENTIONAL THERAPY |
MOTOR IMAGERY WITH MIRROR THERAPY ( FOR 40 MINUTES)
CONVENTIONAL TREATMENT (FOR 40 MINUTES ) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Acute stroke onset within one to two week
2.Ischemic type of stroke
3.No cognitive dysfunction according to mini-mental state examination(more than 24),
4.Fugl Meyer upper extremity score between 32 and 52
|
|
| ExclusionCriteria |
| Details |
1.Aphasia
2.Vision or hearing disorders
3.Spatial neglect
4.Hemianopia
5.Post stroke shoulder pain
6.A Previous case of shoulder dislocation or rotator cuff tear
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ACTION RESEARCH ARM TEST |
10 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FUGL MEYER ASSESSMENT UPPER EXTREMITY |
10 DAYS |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/11/2020 |
| Date of Study Completion (India) |
26/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="3" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In stroke ,the impairment of the upper extremity is the most disabled consequences that limits independent living .Initially arm weakness that persists even after three to six months .The study purpose is to understand the combined effectiveness of motor imagery with mirror therapy as the early rehabilitation for improving the hand function in post stroke patients. The combination of two approaches motor imagery and mirror therapy for the execution of activities of the upper extremity improve the performance of upper limb functional recovery and improve the quality of life . |