CTRI Number |
CTRI/2025/06/088325 [Registered on: 05/06/2025] Trial Registered Prospectively |
Last Modified On: |
03/06/2025 |
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
|
To study the immediate effect of imagining bilateral arm and hand movements followed by its intensive training on bilateral arm and hand activities to improve bilateral arm and hand function in individuals with stroke |
Scientific Title of Study
|
IMMEDIATE EFFECT OF MOTOR IMAGERY MI ALONG WITH HAND ARM BIMANUAL INTENSIVE TRAINING HABIT ON UPPER EXTREMITY FUNCTION IN SUBJECTS WITH STROKE A RANDOMIZED 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 |
Dr Lakshmiprabha Rangarajan |
Designation |
Professor (Addl) |
Affiliation |
P. T. School and Centre Seth GSMC and KEMH |
Address |
P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Building, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India
Mumbai MAHARASHTRA 400012 India |
Phone |
9870487879 |
Fax |
|
Email |
laps2204@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Lakshmiprabha Rangarajan |
Designation |
Professor (Addl) |
Affiliation |
P. T. School and Centre Seth GSMC and KEMH |
Address |
P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Building, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India
Mumbai MAHARASHTRA 400012 India |
Phone |
9870487879 |
Fax |
|
Email |
laps2204@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Mansvi Gawande |
Designation |
Post graduate Neurophysiotherapy student |
Affiliation |
P. T. School and Centre Seth GSMC and KEMH |
Address |
P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Building, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India
Mumbai MAHARASHTRA 400012 India |
Phone |
8237905008 |
Fax |
|
Email |
gawandemansvi@gmail.com |
|
Source of Monetary or Material Support
|
P. T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Bldg, E Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India |
|
Primary Sponsor
|
Name |
NIL |
Address |
NIL |
Type of Sponsor |
Other [NIL] |
|
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 Lakshmiprabha Rangarajan |
P. T. School and Centre, Seth GS Medical College and KEM Hospital |
P.T. School and Centre Seth GSMC and KEMH 402 Physiotherapy department, Room number 3, OC Building, Ernest Borges road, opp to TATA Hospital, Parel Mumbai MAHARASHTRA 400012 India Mumbai MAHARASHTRA |
09870487879
laps2204@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee 3 of Seth GSMC and KEMH |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Hand Arm Bimanual Intensive Training (HABIT) |
In this type of intervention, the subject will be made to sit on a chair in front of the table.The unaffected upperlimb and affected upperlimb will be placed on the table.They will be performing a set of Symmetrical and Asymmetrical activities in HABIT.Instruction to physically practice each activity will be given to the subject.Then they will be made to perform the same set of activities. 2 minutes rest period will be given in between each activity.This intervention is administered for one time as we are assessing immediate effect. |
Intervention |
Motor Imagery(MI) along with Hand Arm Bimanual Intensive Training (HABIT) |
In this type of intervention, the subject will be made to sit on a chair in front of the table containing task-related materials like video displayed on the laptop screen, bottle, paper ,container, etc . The unaffected upperlimb and affected upperlimb will be placed on the table. The subject will be first asked to observe the video of motor tasks .Then , subject will be asked to mentally practice each activity.They will be performing a set of Symmetrical and Asymmetrical activities in HABIT. Instruction to physically practice each activity will be given to the subject.Then they will be made to perform the same set of activities. 2 minutes rest period will be given in between each activity. This intervention is administered for one time as we are assessing immediate effect.
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Bruunstorm hand functions grades from 2 to 5, Subjects diagnosed with subacute [ 3 months to 6 months] and chronic [6 months or more] unilateral stroke patients ,
Participants were included if they scored more than 25 on the MIQ
|
|
ExclusionCriteria |
Details |
Any acute cardiovascular, respiratory and musculoskeletal impairment,Uncontrolled Diabetes and Hypertension,Uncorrected Visual and Auditory impairments, Any other neurological impairments other than Stroke, Any Psychiatric illness |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Chedoke Arm and Hand Action Inventory scale-7(CAHAI-7)
Action Research Arm Test(ARAT)
Fugl-Meyer Assessment-upper extremity Scale
|
1 Year |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="32" Sample Size from India="32"
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
|
Phase 2 |
Date of First Enrollment (India)
|
14/06/2025 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Open to Recruitment |
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
|
Stroke is sudden loss of neurological functions caused by impaired perfusion of
brain. Absence of ankle control is one of the most prevalent and challenging
problem in rehabilitation following stroke . In some patients there is serious loss
of strength in affected limb which makes it difficult to carryout exercises in
paralytic limb and it also demotivates the patient. Patients with stroke have
difficulty in sit to stand activity, standing, walking and weight bearing on
affected limb as a result of pain, spasticity, muscle weakness, sensory problems
and affected balance. Mirror therapy is a type of intervention in which mirror is
placed in midsagittal plane to create a reflection of non affected limb to create
an illusion as affected limb is moving normally. It helps to create an illusion as
if affected limb is moving and thereby creating a beneficial effects. Studies have
been done which explains the beneficial effect in affected limb if resistance
training of unaffected limb is done. So the purpose of this study is to find
whether the resisted ankle dorsiflexor exercises augment the effect of mirror
therapy in motor recovery of stroke patients or not. Also to check whether there
is any immediate effect of combination of mirror therapy and resisted ankle
exercises on motor outcomes and functional mobility in post stroke patients.
There is a need to check whether the participant feels that the movement is
happening in affected limb or not during the session. Therefore there is also a
need to assess the generation of the sense of agency during the session. To carry
the reseach work prior permission of Institutional Ethics Committee will be
taken. Subjects will be randomly assigned into two groups using computerized
randomisation chart, Group A and Group B. Group A will undergo mirror
therapy with resisted ankle dorsiflexor exercises and Group B will undergo
mirror therapy alone. Pre intervention assessment of both the groups will be
done which includes- Active and passive range of motion using standardized
universal goniometer, Modified Tardieu Scale, Timed up and go test, walking
velocity using 10 meter walk test. Additionally measurement sense of agency
will be evaluated using visual analogue scale of both the group. If the data is
normally distributed then parametric tests like paired and unpaired t-tests will be used and if the data is not normally distributed then non parametric tests like
Mann-Whitney U test and Wilcoxon signed-rank test will be used for intra and
inter group analysis. |