| CTRI Number |
CTRI/2019/12/022246 [Registered on: 03/12/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Conventional demonstration of mirror therapy versus app based teaching of mirror therapy |
|
Scientific Title of Study
|
A Randomized Control Trial to Compare the Effectiveness of Conventional Demonstration of Mirror Therapy Versus App Based Teaching of Mirror Therapy on Functional Improvement of Upper Extremity Among Patients with Stroke , in PGIMER Chandigarh,(2018-20) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Durga Lekshmy UK |
| Designation |
MSc Student |
| Affiliation |
National Institute of Nursing Education |
| Address |
National Institute of Nursing Education , PGIMER ,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855555329 |
| Fax |
|
| Email |
durgalekshmyuk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Dandhapani |
| Designation |
Lecturer |
| Affiliation |
National Institute of Nursing Education |
| Address |
National Institute of Nursing Education , PGIMER ,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855151528 |
| Fax |
|
| Email |
manjuseban@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Durga Lekshmy UK |
| Designation |
MSc Student |
| Affiliation |
National Institute of Nursing Education |
| Address |
National Institute of Nursing Education , PGIMER ,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855555329 |
| Fax |
|
| Email |
durgalekshmyuk@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| 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 |
| DURGA LEKSHMY UK |
PGIMER,CHANDIGARH |
NEURO WARD ,3rd floor nehru block,neurology department
Chandigarh
CHANDIGARH |
9855555329
durgalekshmyuk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CONVENTIONAL MIRROR THERAPY , APP BASED MIRROR THERAPY |
Providing Stroke Rehablitation Of Upper Extrimity Using Mirror Therapy both Demonstration method And app based Teaching
demonstration and teaching given once and reinforcement of practice through telephone contacts.follow up after one month and three month. |
| Comparator Agent |
CONVENTIONAL MIRROR THERAPY , APP BASED MIRROR THERAPY |
Providing Stroke Rehablitation Of Upper Extrimity Using Mirror Therapy both Demonstration method And app based Teaching at first contact and follow up after one month and 3 months and reinforcement of practice through telephone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having hemiplegia due to stroke.
2)Having MMSE SCORE>24.
3)Able to obey commands.
4)Available at the time of data collection.
5)Willing to participate in the study.
6)No history of musculo skeletal injury in the affected upper extremity.
|
|
| ExclusionCriteria |
| Details |
1)Patients with quadriplegia, and paraplegia due to stroke
2)Having muscle strength of 0
3)Cortical stroke
4) Gait disorders
5)Head injury
-Cerebellar ataxia
-spinal ataxia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| functional improvements of upper extremities |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| activities of daily living |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/12/2019 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
this study will be publish in good authentic journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The main purpose of the study is to compare the conventional demonstration method of mirror therapy and app based teaching of mirror therapy. This study helps to explore a new method of teaching of mirror therapy . |