| CTRI Number |
CTRI/2024/06/068648 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative effectiveness of One treatment techniques in three ways on walking ability and balance in stroke patients |
|
Scientific Title of Study
|
Comparative efficacy of various Constraint-Induced Movement Therapy techniques for lower extremity function in subject with stroke: a randomised clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suparna Bandyopadhyaya |
| Designation |
MPT student |
| Affiliation |
West Bengal University of Health Sciences(WBUHS) |
| Address |
Department of physiotherapy, Nopany Institute of Healthcare Studies.
Kolkata
WEST BENGAL
700006
India |
| Phone |
8250984004 |
| Fax |
|
| Email |
suparnamoom9.6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shilpasree Saha |
| Designation |
Assistant Professor |
| Affiliation |
West Bengal University of Health Sciences(WBUHS) |
| Address |
Department of Physiotherapy, Nopany Institute of Healthcare Studies
Kolkata
WEST BENGAL
700006
India |
| Phone |
8250984004 |
| Fax |
|
| Email |
shilpasree@nihs.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Suparna Bandyopadhyaya |
| Designation |
MPT student |
| Affiliation |
West Bengal University of Health Sciences(WBUHS) |
| Address |
Department of Physiotherapy, Nopany Institute of Healthcare Studies
Kolkata
WEST BENGAL
700006
India |
| Phone |
8250984004 |
| Fax |
|
| Email |
suparnamoom9.6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nopany Institute of Healthcare studies
2C, Nanda Mullick Lane, Nutan Bazar, Girish Park, Jorasanko, Kolkata, West Bengal 700006, India |
|
|
Primary Sponsor
|
| Name |
Nopany Institute of Healthcare Studies |
| Address |
2C , Nando mullick lane, Girish park, 700006 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Suparna Bandyopadhyay |
Nopany institute of healthcare studies |
Department of Physiotherapy, Nopany Institute of Healthcare Studies
Kolkata
WEST BENGAL |
8250984004
suparnamoom9.6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nopany Institute of Healthcare Studies Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
m-CIMT with Ankle mass as restraint device |
120 minutes/ session ,5 session /week for 2 weeks |
| Comparator Agent |
m-CIMT with Full leg orthosis as restraint device
|
120 minutes/ session ,5 session /week for 2 weeks |
| Comparator Agent |
m-CIMT without restraint device. |
120 minutes/ session ,5 session /week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject with mild to moderate disability according to Brunnstrom Recovery stages between ≥ III
2. Good cognitive ability (Mini-Mental status examinationscore≥24)
3. Subject able to stand and walk with minimal assistance
4. Subjects with cerebral stroke
|
|
| ExclusionCriteria |
| Details |
1. History of Unstable cardiac conditions Other adverse medical conditions affecting balance, gait, pain, or any kind of discomfort that can interfere with the completion of the training
2. Subjects having tightness contracture and deformity
3. Berg Balance scale score ≤35
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Balance: Berg Balance Scale (BBS)
Gait : Dynamic Gait Index (DGI)
Functional mobility : Fugl-Meyer Assessment of Motor Recovery of Lower
Extremity (FMA-LE)
|
2 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life- stroke specific quality of life. (SSQOL) |
2 years |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
24/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
SUMMARY: Balance and gait impairment following a stroke is a very common cause of long-term disability worldwide. At least 50% of post-stroke subjects are unable to do activities of daily living (ADL) independently. More than 80% of post-stroke subjects suffer from gait disturbance that regains to some extent in the first 3-6 months following the stroke. But community ambulation is still jeopardized. Walking ability is an important predictor for good quality of life and functional independence following a stroke. Reclaiming walking ability is the most important goal for post-stroke subjects. Various approaches are implemented in physiotherapy to regain the functional mobility of subjects with stroke. Modified constraint-induced movement therapy(m-CIMT) exerts a wonderful effect on enhancing motor recovery by improving neural plasticity. Purpose of the study Purpose of the study to find out the efficacy of various modified constraint-induced movement therapy (m-CIMT) techniques for lower extremity function in patients with stroke. Objectives To determine the efficacy of various modified constraint-induced movement therapy (mCIMT) techniques for lower extremity function in stroke patient and to compare the effect of these 3 different techniques. Material and methods Post-stroke subjects will be chosen based on the inclusion and exclusion criteria. Subjects will be randomly divided into three groups (n=12) to compare the efficacy of various modified constraint-induced movement therapy (m-CIMT) techniques for lower extremity function in patients with stroke. Group A, B, and C will receive the same exercise protocol with different restraining techniques. Treatment will be provided for 120 minutes per session, 5 days a week for a total of 2 weeks. To immobilize the unaffected limb group A will be using an ankle mass in the nonparetic limb, group B will put on full leg orthosis during the exercise program. But group C will be asked to keep their non-paretic hip and knee in full extension with their foot flat. Post intervention data will be obtained after 2 weeks of intervention. Analysis: Data analysis will be done by using SPSS 25 . Anova will be used to perform the data analysis between the groups and paired T test will be used for within group data analysis |