CTRI

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CTRI Number

CTRI/2025/08/093041 [Registered on: 13/08/2025] Trial Registered Prospectively

Last Modified On:

13/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Other (Specify) [Rehabilitation]

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

Comparative effect of Action Observation Therapy and task oriented therapy versus task oriented therapy alone on balance & self-efficacy in individual with stroke

Scientific Title of Study

Combined effect of action observation therapy and task-oriented training on balance and self-efficacy after stroke

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Ekta khokhar
Designation	postgraduate student ( Master of occupational therapy)
Affiliation	ISIC Institute of rehabilitation Sciences
Address	Indian spinal injuries center- institute of rehabilitation sciences, 2nd floor sector c vasant kunj South West DELHI 110070 India
Phone	08586886496
Fax
Email	ektakhokhar333@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Priyanka Vijay
Designation	Associate professor
Affiliation	ISIC Institute of rehabilitation Sciences
Address	Indian spinal injuries center- institute of rehabilitation sciences, 2nd floor Sector-c, Vasant Kunj South West DELHI 110070 India
Phone	9910631430
Fax
Email	priyanka_vijay02@yahoo.co.in

Details of Contact Person
Public Query

Name	Dr Priyanka Vijay
Designation	Associate professor
Affiliation	ISIC Institute of rehabilitation Sciences
Address	Indian spinal injuries center- institute of rehabilitation sciences, 2nd floor Sector-c, Vasant Kunj South West DELHI 110070 India
Phone	9910631430
Fax
Email	priyanka_vijay02@yahoo.co.in

Source of Monetary or Material Support

PMR Department, Indian Spinal Injuries Center

Primary Sponsor

Name	Indian Spinal Injuries Center
Address	Sector-c, Vasant Kunj, New Delhi-110070
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr priyanka vijay	Indian Spinal Injuries Center	PMR department, Ground Floor, ISIC, Sector-C, Vasant Kunj South West DELHI	09910631430 priyanka_vijay02@yahoo.co.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Indian Spinal Injuries Center Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G811\|\|Spastic hemiplegia,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Action Observation Therapy and task-oriented training.	Close standing Ball kicking along with walking Step up and step down Stair climbing Standing and reach out for target Backward walking Sitting and reach out for target Lateral walking Walking on an obstacle course Intervention will be provided for a period of 5 session per week for 4 weeks with each session lasting for 30 mins.
Comparator Agent	Task-oriented training	Close standing Ball kicking along with walking Step up and step down Stair climbing Standing and reach out for targets Backward walking Sitting and reach out for target. Lateral walking Walking on an obstacle corse Intervention will be provided for a period of 5 session per week for 4 weeks with each session lasting for 30mins.

Inclusion Criteria

Age From	20.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Individual diagnosed with stroke Duration of stroke- late subacute to chronic MOCA- greater and equal to 26 BRS stage greater and equal to 3 in lower limb Ability to sit and stand up independently.

ExclusionCriteria

Details

Individual having visual perceptual deficit
individual prediagnosed with any neurological or musculoskeletal disorders.
Individual with any other sensory issues that affect balance.
Individual with uncorrected visual and hearing defects.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Balance using Berg balance scale time up and go self efficacy using Activity specific balance scale	Day 1 before intervention and Day6 after intervention

Secondary Outcome

Outcome	TimePoints
nil	nil

Target Sample Size

Total Sample Size="20"
Sample Size from India="20"
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)

27/08/2025

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="0"
Months="7"
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

Brief Summary

Stroke often leads to long-term disability, particularly affecting balance, which limits daily activities and reduces quality of life. Task Oriented Training improves functional ability through repetitive task practice but shows only modest gains in balance and self-efficacy. Action Observation Therapy , which activates the mirror neuron system, enhances motor learning by mentally simulating movements. Although TOT alone has shown limited impact on functional movement, integrating it with AOT may result in smoother, more coordinated actions and improved independence. This study explores the combined effect of action observation therapy and task oriented training on balance and self-efficacy in individuals recovering from stroke . The study design will be experimental and 20 participants will be recruited from PMR department ISIC New Delhi. The participants age will be 20 to 65 years, greater or equal to 3 months post stroke, Brunnstrom stage greater and equal 3 for lower limb. Ability to sit and stand independently . The exclusion criteria will be individual having visual perceptual deficit and any other sensory issues that affect balance. Individual prediagnosed with any neurological and musculoskeletal disorders. Individual with uncorrected visual and hearing defects. Pre intervention assessment will be done using Berg balance scale, Time up & go scale, Activity specific balance confidence scale. Participants will then be divided into two groups Group A and Group B with 10 participants in each group. Group A will receive Action observation therapy and Task oriented training and Group B will receive sham AOT and task oriented training . The training program will be given 30 minutes,5 days a week for 4 weeks. Then the post intervention assessment will be done after 4 weeks of intervention using same outcome measures i.e. Berg Balance Scale, Time Up & Go, Activity specific balance scale .