| CTRI Number |
CTRI/2019/02/017488 [Registered on: 06/02/2019] 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 Trial |
|
Public Title of Study
|
To compare the effect of movement in front of Mirror and Movement of affected hand on upper limb movement in paralytic patients. |
|
Scientific Title of Study
|
Comparison between the effect of Mirror Therapy and Constraint-Induced Movement Therapy on upper extremity motor function in sub acute stroke patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema Sahu |
| Designation |
MPT |
| Affiliation |
MGM school of physiotherapy |
| Address |
MGM school of physiotherapy,N-6,CIDCO,Aurangabad,Maharashtra
MGM school of physiotherapy,N-6,CIDCO,Aurangabad,Maharashtra
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8319650212 |
| Fax |
|
| Email |
seema.sahu0606@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAshwini Kale |
| Designation |
Associate Professor |
| Affiliation |
MGM school of physiotherapy |
| Address |
MGM school of physiotherapy,N-6,CIDCO,Aurangabad,Maharashtra
MGM school of physiotherapy,N-6,CIDCO,Aurangabad,Maharashtra
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7263891882 |
| Fax |
|
| Email |
ashwinikalept@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Seema Sahu |
| Designation |
MPT |
| Affiliation |
MGM school of physiotherapy |
| Address |
MGM school of physiotherapy,N-6,CIDCO,Aurangabad,Maharashtra
MGM school of physiotherapy,N-6,CIDCO,Aurangabad,Maharashtra
MAHARASHTRA
431003
India |
| Phone |
8319650212 |
| Fax |
|
| Email |
seema.sahu0606@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital |
|
Primary Sponsor
Modification(s)
|
| Name |
Seema Sahu |
| Address |
MGM medical college and hospital, OPD no. 237,N-6,CIDCO,Aurangabad,Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Seema Sahu |
MGM Medical College and Hospital |
N-6,Cidco,Aurangabad,431003
Aurangabad
MAHARASHTRA |
8319650212
seema.sahu0606@gmail.com |
| Seema Sahu |
MGM Medical College and Hospital |
Department-medicine, division-male and female ward, ward no. 440 and 450.
Aurangabad
MAHARASHTRA |
8319650212
seema.sahu0606@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECapproval1 |
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 |
| Comparator Agent |
Constraint-Induced Movement Therapy(CIMT) |
CIMT group will receive 6 hours of CIMT 5 days per week for weeks.In CIMT group patient will do task oriented exercise along with ROM exercise of upper limb. The task oriented practice includes:
1.Picking up a cup from the table
2.Taking it to the mouth
3.Writing letters or drawing a circle
4.Transferring an object from one side to another on a table.
The patient’s non-paretic arm restrained from use by having the patient wear a safety mitt up to 90% of waking hours.
|
| Intervention |
Mirror Therapy |
Mirror Therapy group will receive 1 hour of mirror therapy 5 days per week for 4 weeks.In first week patient will do ROM exercise of elbow,wist,hand and fingers.In 2nd and 3rd week patient will do some graded exercise along with ROM exercise (arm-hand dexterity activities) of upper limb. In 4th week patient will do finger dexterity activities along with ROM exercise. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with MCA infarct,
2.Sub-acute stroke patients,
3.MMSE SCORE more than 24 out or 30,
4.Adequate vision and hearing,
5.Brunnstrom stage 2-4 |
|
| ExclusionCriteria |
| Details |
1.History of previous stroke or other neurological disease or disorder,
2.Participants with sever spasticity or flaccidity in upper limb. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Fugal Meyer Assessment(FMA)
2.Box and Block Test(BBT) |
Baseline assessment and after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Box and Block Test(BBT) |
Baseline assessment and after 4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2019 |
| Date of Study Completion (India) |
15/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Experimental study will conduct in MGM hospital Aurangabad.The purpose of study was to compare the effect of Mirror Therapy and constraints induced movement therapy on upper extremity motor function. Thirty-six patients with subacute were randomly assigned to the mirror therapy group(n=18) and CIMT group (n=18).Mirror therapy group received 1 hour MT 5 days per week for 4 weeks and CIMT group 6 hour per day for 5 days per week for 4 weeks. The following outcome measures will assess upper extremity motor function on first day of assessment and then after 4 weeks of intervention outcome measures: Fugal Meyer Assessment (FMA) and Box and Block Test (BBT) |