| CTRI Number |
CTRI/2025/06/088762 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of motor imagery versus action observation training on lower limb function and gait in hemiparesis. |
|
Scientific Title of Study
|
The effect of motor imagery versus action observation training on lower limb function and gait in individuals with hemiparesis. |
| Trial Acronym |
The effect of motor imagery versus action observation training on lower limb function and gait in individuals with hemiparesis. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SNEHA UPADHYAY |
| Designation |
MPT student |
| Affiliation |
LJ Institue of physiotherapy, LJ univesity |
| Address |
Room no. 203, LJ institute of Physiotherapy, LJ university, SG highway, sarkhej, ahemdabad, gujarat- 382210
Room no. 203, LJ institute of physiotherapy, LJ university, SG highway, sarkhej, ahemdabad, gujarat- 382210
Ahmadabad
GUJARAT
382210
India |
| Phone |
9860279004 |
| Fax |
|
| Email |
upadhyay.sneha.01234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SNEHA UPADHYAY |
| Designation |
MPT student |
| Affiliation |
LJ Institue of physiotherapy, LJ univesity |
| Address |
Room no. 203,LJ institute of physiotherapy, LJ university, SG highway, sarkhej, ahemdabad, gujarat- 382210
Room no. 203,LJ institute of physiotherapy, LJ university, SG highway, sarkhej, ahemdabad, gujarat- 382210
Ahmadabad
GUJARAT
382210
India |
| Phone |
9860279004 |
| Fax |
|
| Email |
upadhyay.sneha.01234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Upadhyay |
| Designation |
MPT student |
| Affiliation |
LJ Institue of physiotherapy, LJ univesity |
| Address |
Room no. 203, LJ institute of physiotherapy, LJ university, SG highway, sarkhej, ahemdabad, gujarat- 382210
Room no. 203, LJ institute of physiotherapy, LJ university, SG highway, sarkhej, ahemdabad, gujarat- 382210
Ahmadabad
GUJARAT
382210
India |
| Phone |
9860279004 |
| Fax |
|
| Email |
upadhyay.sneha.01234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 203,LJ institute of physiotherapy, LJ university, SG highway, sarkhej, ahemdabad, gujarat- 382210 |
|
|
Primary Sponsor
|
| Name |
Sneha Upadhyay |
| Address |
Room no. 203,LJ institute of physiotherapy, LJ university, SG highway, sarkhej, ahemdabad, gujarat- 382210 |
| Type of Sponsor |
Other [Physiotherapy college (LJ institute of physiotherapy, LJ university).] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SNEHA UPADHYAY |
LJ INSTITUTE OF PHYSITHERAPY OPD |
LJ institute of physiotherapy, LJ university, SG highway, sarkhej, ahemdabad, gujarat- 382210
Ahmadabad
GUJARAT |
9860279004
upadhyay.sneha.01234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| lLok Jagrut institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Action Observation Training |
Group B: - Action observation training along with conventional therapy.
Duration: - 5 days a week for 4 weeks – 50 min
In this, the patient has to watch videos / therapist (i.e. the observation phase) and will be asked to imitate the tasks. (i.e. the execution phase).
The video consists of: -
1) 3-minute video of walking on flat surface.
2) 3-minute video of walking on a slope.
3) 3-minute video of climbing the stairs.
4) Then the individual will be asked to walk for 5 minutes each on the same flat surface, slope and steps as in the video. |
| Intervention |
Motor Imagery Training |
GROUP A: - Motor imagery along with conventional therapy.
Duration: - 5 times per week for 4 weeks – 50min
Step-1: -the patients will watch the videos recorded by the therapist.
Step-2: - the patient will be made to close their eyes and imagine themselves practicing the task.
Step-3: - the patient will be asked to try the activity with the affected limb following the verbal command given by the therapist.
ACTIVITIES: -
1)Sit to stand for 10 sec
2)Sit to stand placing the non-paralysed limb on the step tilt the body on the hemiparetic side.
3)Sit to stand then do single leg stand on the non-paralysed side hold for 10 sec
4)Walking
5)Stair climbing
Progression of exercises to be estimated by voluntary control grading.
|
|
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Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(1) AGE: - 45 - 65 YEARS
(2) Both gender
(3) Patient should be able to understand and follow simple verbal instructions
(4) Patients with chronic stroke
(5) FMA-LL: - 22 and above (4)
(6) ACE-III: - 88 and above
|
|
| ExclusionCriteria |
| Details |
1)Patient with Visual deficits
2)Patient with any severe musculoskeletal disorders including lower limb.
3)Patients with any other neurological disorders including lower limb.
4)Patients with severe cardiopulmonary disorders.
5)No severe cognitive disorders that would interfere with the study’s purpose.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Fugl-meyer assessment of lower limb
2. Dynamic gait index |
FMA-LL after 4 Weeks of intervention
DGI after 4 Weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
25/06/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
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Brief Summary
|
OBJECTIVES :- 1)To study the effect of motor imagery on lower extremity function in stroke individuals by fugl meyer assessment. 2)To study the effect of motor imagery on gait in stroke individuals by dynamic gait index. 3)To study the effect of action observation training on lower extremity function in stroke individuals by fugl meyer assessment. 4)To study the effect of action observation training on gait in stroke individuals by dynamic gait index. 5)To compare the effects of motor imagery and action observation training on lower limb extremity functions in stroke individuals. 6)To compare the effects of motor imagery and action observation training on gait in stroke individuals.
METHOD STUDY DESIGN – A COMPARATIVE STUDY Group A: - Motor imagery along with conventional physiotherapy treatment. Group B: - Action observation training along with conventional physiotherapy. Both the groups will receive the training for 4 weeks. The conventional physiotherapy included will be mat activities , stretching , strengthening exercises and gait training. Baseline and post treatment measures of fugl meyer assessment and dynamic gait index will be evaluated.
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