| CTRI Number |
CTRI/2019/12/022547 [Registered on: 30/12/2019] Trial Registered Prospectively |
| Last Modified On: |
30/03/2024 |
| 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 constraining the functional hand or normal hand of a paralyzed patient whose other hand is spastic or have muscle tightness. |
|
Scientific Title of Study
|
Effect of modified CIMT on hand functions in patient suffering from Stroke. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaspreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambeshwar University of Science And Technology Hisar Haryana |
| Address |
Department Of Physiotherapy Guru Jambeshwar University of Science And Technology Hisar Haryana
Department Of Physiotherapy Guru Jambeshwar University of Science And Technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet_malik16@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaspreet kaur |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambeshwar University of Science And Technology Hisar Haryana |
| Address |
Department Of Physiotherapy Guru Jambeshwar University of Science And Technology Hisar Haryana
Department Of Physiotherapy Guru Jambeshwar University of Science And Technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet_malik16@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Piyush Bhardwaj |
| Designation |
PG Student |
| Affiliation |
Guru Jambeshwar University of Science And Technology Hisar Haryana |
| Address |
Department Of Physiotherapy Guru Jambeshwar University of Science And Technology Hisar Haryana
Department Of Physiotherapy Guru Jambeshwar University of Science And Technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9911968332 |
| Fax |
|
| Email |
Bhardwajpiyush1947@gmail.com |
|
|
Source of Monetary or Material Support
|
| Piyush Bhardwaj PG student Department Of Physiotherapy Guru Jambeshwar University of Science And Technology Hisar Haryana |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Department Of Physiotherapy Guru Jambeshwar University of Science And Technology Hisar Haryana |
| Type of Sponsor |
Other [University] |
|
|
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 Jaspreet Kaur |
physiotherapy department |
Department Of Physiotherapy Guru Jambeshwar University of Science And Technology Hisar Haryana
Hisar
HARYANA |
9466092657
jaspreet_malik16@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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 |
modified constrained induced therapy |
modified constrained induced therapy is an intervention used to improve functionality and mobility in the more affected upper extremity in post stroke pateints . it involves restraining ,repetitive task practice and application of behavioural techniques.the total intervention will be of two weeks in two groups. 6 hours per day time will be given to both. In one group it will be continuous and in other it will be with intervals in btw the 6 hour session. |
| Comparator Agent |
Range of Motion exercises as control group |
wrist flexion and extension exercises with finger movements.The total intervention time is of two weeks. 2 hours per day during treatment session before therapist and few hours at home as per patients convenience. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients who had history of stroke.
Patient whose hand is affected and is unable to perform ADL due to it.
Patient must have Balance and stability to move using a glove in the unaffected hand.
pateint must be able to perform 20 degrees of active wrist extension and 10 degrees of active finger extension.
Availability of a family member to supervise home exercises.
|
|
| ExclusionCriteria |
| Details |
medical problems or cognitive deficit (mini mental status examination score <24) 16 that could interfere with study completion.
Intended or actual participation in any other study that can hamper the collection of data.
Significant pain (≥4 in the visual analog scale 17) in any joint.
A Botox A injection for the upper extremity within 3 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient rate wrist/hand evaluation score
Box and Block test |
baseline-0 weeks
post intervention-2 weeks
review of patient-4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pateint rate wrist/hand evaluation score. |
baseline-0 weeks
post intervention-2 weeks
review of patient-4 weeks |
|
|
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2019 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Modified Constraint-induced movement therapy (mCIMT) promotes movement of upper extremities in hemiplegic patients. The major components of mCIMT include intense repetitive (task oriented) training and behavioral shaping of the impaired limb with immobilization of the unimpaired arm. Subjects will be selected on the basis of exclusion and inclusion criteria and a comparative study will be conducted among three Groups where participants in Group A will be given intervention of mCIMT without interval ,Group B will be given intervention of mCIMT with interval and Group C will be a control group . patient in group A will be given intervention of mCIMT thrice a week ,in which patient has to wear constraint at home for 2 hours just before and after the 2 hour treatment of behavioral shaping with constraint without any interval .Patient has to perform behavioral shaping exercises at home too. Each patient in group B would be given intervention of mCIMT thrice a week ,where patient has to wear constraint at home for 2 hours whenever he/she desires after and before the 2 hour treatment of behavioral shaping with constraint . While patient in Group C would be given only simple range of motion exercises with some resistance training without any constraint thrice a week for 2 hours a day and patient will be asked to perform the exercises at home before and after the treatment . Their will be pre and post assessment of the subjects by Patient rated wrist/hand evaluation score and box and block test . Data obtained will be analysed for the statistical significance. |