Clinical trial NCT05557968: Action Observation Therapy for Lower Limb in Stroke
Official title: Effects of Action Observation Therapy on Stair Walking, Balance, and Self-efficacy in Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fugel Meyer assessment scale for lower limb
timeFrame: week 6
measure: Berg Balance Scale
timeFrame: week 6
measure: Timed Up and Down Stair Test
timeFrame: week 6
measure: Step test
timeFrame: week 6
measure: Timed up and go test
timeFrame: week 6
Secondary outcomes:
measure: Self-efficacy scale
timeFrame: week 6
Other outcomes:
Locations:
city: Mansehra
country: Pakistan
facility: Helping hand institute of rehabilitation sciences
Study officials:
affiliation: Riphah International University
name: Ayesha Afridi, PhD*
role: PRINCIPAL_INVESTIGATOR
References: