Action Observation Therapy for Lower Limb in Stroke

NCT ID: NCT05557968

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-03-01

Brief Summary

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This study focuses on the effects of Action Observation therapy on stair walking, balance and self-efficacy in chronic stroke patients. This study will be conducted in Helping Hands Institute of Rehabilitation Sciences and Shifa Surgical Hospital Mansehra.

It is a Randomized Control Trial. Non probability convenient sampling technique will be used to assess a total number of 40 respondents. Questionnaires and consent forms will be filled by the respondents. Each patient will be screened by using a simple selection Performa relevant to inclusion and exclusion criteria.

Total 30 patients will be included in the study and then divided into two groups i.e. Action observation therapy and Convention Therapy group with 15 individuals in each. Each group will be assessed thrice i.e. pre, post and follow up surveys. Each of them will receive the convention therapy for 30 mins except for the Action Observation therapy (AOT) group, which will also receive the additional 30 minutes session of action observational training. Total 18 sessions, 3 days a week for a total of six weeks will be performed on each patient.

Fugel Meyer Assessment Scale for lower limb, Timed Up and Go test, Timed Stair Test, Step test and self-efficacy scale will be used for the assessment. Baseline assessments of both group will be done on 1st week before the application of protocol, second assessment will be done on 4th week and then final assessment will be done on 6th week of the protocol.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Conventional Therapy

1. Active range of motion exercises.
2. Passive range of motion exercises
3. Balance exercises.
4. On-ground gait training without watching videos

Group Type ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type OTHER

conventional therapy will be given for stroke patients and three assessments i.e. pre, post and follow up surveys, a session of 30 minutes, 3 times weekly for a six week period.

Total 18 sessions would be performed on each patient for six weeks

Action Observation Therapy (AO)

Conventional therapy in addition to observing images related to stair walking will be observed and physical training will performed to imitate tasks with a physical therapist. While observing the image, they will be instructed to think that their body was performing the movement of the image

Group Type EXPERIMENTAL

Action Observation Therapy (AO)

Intervention Type OTHER

The video consists of :

1. Ascending and descending the step box.
2. Ascending and descending the stairs in the treatment room.
3. Holding the handrails to climb and descend the stairs inside and outside the building.
4. Climbing and descending the stairs inside and outside the building without holding the handle.
5. Climbing and descending the sidewalk block

Interventions

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Conventional Therapy

conventional therapy will be given for stroke patients and three assessments i.e. pre, post and follow up surveys, a session of 30 minutes, 3 times weekly for a six week period.

Total 18 sessions would be performed on each patient for six weeks

Intervention Type OTHER

Action Observation Therapy (AO)

The video consists of :

1. Ascending and descending the step box.
2. Ascending and descending the stairs in the treatment room.
3. Holding the handrails to climb and descend the stairs inside and outside the building.
4. Climbing and descending the stairs inside and outside the building without holding the handle.
5. Climbing and descending the sidewalk block

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 40-60 years.
* Both male and female.
* Those who can walk more than 10 steps.
* More than 6 months since stroke onset.
* Ability to follow the study instructions-Mini mental state examination (MMSE) score ≥25
* Baseline score of the Fugel Meyer assessment scale is between20 and 60.
* Score of 3 on Modified Rankin Scale (MRS).

Exclusion Criteria

* Patients who cannot perform the active movement of upper limb in pre-stroke condition due to musculoskeletal problems.
* Cardiopulmonary diseases which could hinder their ability to participate in the rehabilitation program in this study.
* Patients with impaired cognition.
* Orthopedic injuries
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayesha Afridi, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Helping hand institute of rehabilitation sciences

Mansehra, , Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Ayesha Afridi, PhD*

Role: CONTACT

Phone: 03325962212

Email: [email protected]

Kainat QADEER, MS NMPT*

Role: CONTACT

Phone: 03499377072

Email: [email protected]

Facility Contacts

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Sania Syed, MS NMPT*

Role: primary

Other Identifiers

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REC/letter-01246 Kainat

Identifier Type: -

Identifier Source: org_study_id