| CTRI Number |
CTRI/2018/01/011376 [Registered on: 16/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/09/2021 |
| 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
|
Effect of Constraint Induced Movement Therapy and Mirror Therapy on Hand Function in Stroke Patients. |
|
Scientific Title of Study
|
A Study to Find Out Effectiveness of Constraint Induced Movement Therapy along with Mirror Therapy for Improvement of Hand Function in Subacute Stroke Phase |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyoti S Jeevannavar |
| Designation |
Associate Professor |
| Affiliation |
SDM College of Physiotherapy |
| Address |
Physiotherapy OPD
OPD number 5
SDM College of Medical Sciences and Hospital
Manjushri Nagar
Sattur
Dharwad.
Manjushri Nagar
Sattur
Dharwad 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9972189767 |
| Fax |
08362462253 |
| Email |
drjyotisj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priya Rajendra Pawar |
| Designation |
Post Graduate Student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
Physiotherapy OPD
OPD number 5
SDM College of Medical Sciences and Hospital
Manjushri Nagar
Sattur
Dharwad.
Manjushri Nagar
Sattur
Dharwad 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9972189767 |
| Fax |
08362462253 |
| Email |
physiohealthindia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priya Rajendra Pawar |
| Designation |
Post Graduate Student |
| Affiliation |
SDM College of Physiotherapy |
| Address |
Physiotherapy OPD
OPD number 5
SDM College of Medical and Hospital
Manjushri Nagar
Sattur
Dharwad.
Manjushri Nagar
Sattur
Dharwad 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9972189767 |
| Fax |
08362462253 |
| Email |
physiohealthindia@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Jyoti S Jeevannavar |
| Address |
SDM College of Physiotherapy
Manjushri Nagar
Sattur
Dharwad - 580009 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prashant Mukkannavar |
Professor, S. D. M. College of Physiotherapy, Dharwad – 580009. Karnataka. India. |
| Priya Rajendra Pawar |
Post Graduate Student, S. D. M. College of Physiotherapy, Dharwad – 580009. Karnataka. India |
| Swathi P |
Post Graduate Student, S. D. M. College of Physiotherapy, Dharwad – 580009. Karnataka. India. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyoti S Jeevannavar |
SDM College of Medical Sciences and Hospital |
Physiotherapy OPD
OPD number 5
Manjushri Nagar
Sattur
Dharwad – 580009.
Karnataka. India
Dharwad
KARNATAKA |
9972189767
08362462253
drjyotisj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S D M Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, Stroke, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A - Experimental Group |
The experimental group received Conventional Neurorehabilitation, Mirror Therapy and Constraint Induced Movement Therapy for a 2 weeks duration |
| Comparator Agent |
Group B - Control Group |
The control group received Conventional Neurorehabilitation and Mirror Therapy for a 2 weeks duration.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Persons who experienced an incident stroke within 3 to 9 months prior to enrollment in the study.
2. Patients with a spasticity of Grade 2 on Modified Ashworth Scale.
3. Patients with an ability to perform minimum 20 degrees active extension at the wrist, 10 degrees of active finger extension, and 10 degrees of thumb abduction/extension.
4. Patients with minimal sensory or cognitive deficits were included for participation in the study
|
|
| ExclusionCriteria |
| Details |
1. Persons with a history of stroke due to head injury or any traumatic condition one year prior to stroke.
2. Persons were excluded from participating in the study if they suffered from associated problems such as global aphasia, cognitive impairment, epilepsy and/or spasticity of Grade 3 and above on the Modified Ashworth Scale.
3. Patients with the presence of a cardiac pacemaker were also excluded from the study.
4. Female patients who were pregnant at the time of data collection.
5. Patients enrolled in any other experimental rehabilitation programme or drug studies. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Action Research Arm Test (ARAT) |
At the time of inclusion in the study and at the end of the two weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Action Research Arm Test (ARAT) |
At the time of inclusion in the study and at the end of the two weeks of intervention. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2016 |
| Date of Study Completion (India) |
25/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Article in process for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a randomized trial to study the effect of Constraint Induced Movement Therapy and Mirror Therapy together on improvement in hand function in subacute stroke patients. 30 participants were randomly assigned to one of the two groups alternately. Experimental group received Conventional Neurorehabilitation, Mirror Therapy and Constraint Induced Movement Therapy. Control group received Conventional Neurorehabilitation and Mirror Therapy. All patients were evaluated using Action Research Arm Test (ARAT) at the beginning and end of 2 weeks. |