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Action Observation Therapy for Lower Limb in Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional Therapy
Action Observation Therapy (AO)
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helping hand institute of rehabilitation sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Therapy

Action Observation Therapy (AO)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fugel Meyer assessment scale for lower limb
Lower limb subscale of Fugel-Meyer Assessment is a subscale measuring lower limb motor recovery. It examines movement, coordination, and reflex action of the hip, knee, and ankle in the supine, sitting, and standing positions. Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully). The score range is 0 to 34, with higher scores indicating better lower limb motor performance
Berg Balance Scale
The Berg Balance Scale (BBS) is a functional balance measurement and consists of 14 items(30). Each item is a 5-point ordinal scale ranging from 0 to 4, with 0 indicating an inability to complete the task entirely and 4 indicating an ability to complete the task criterion. Scores can range from 0 to 56. The higher the score, the better the postural control
Timed Up and Down Stair Test
To determine the change in stair walking ability, a timed stair test (TST) is performed. TST is a functional evaluation tool that evaluates stair walking ability in daily life. The measurement method is to measure the time it takes for the person to start climbing the stairs according to the command of the examiner and come down from the end of the stairs. One stairway used in this study is 95 cm wide, 15 cm long, and 15 cm high, for a total of 12 spaces
Step test
A step test (ST) was used to determine the change in balance ability required for stair walking. ST is an evaluation tool that examines the dynamic balance ability in the standing posture of stroke patients. The ST is a reliable measurement tool when the number of steps is counted by either experienced or inexperienced examiners by viewing videotapes. As for the measurement method, the subject stands in front of a 7.5 cm high stool 5 cm and then counts the number of times while repeatedly raising and lowering one foot as quickly as possible for 15 seconds
Timed up and go test
The Timed up and go test (TUG) is the time measured when standing up, walking straight for 3m, turning, walking back to the chair, and sitting down. Time less than 10 seconds shows functional independence, and time more than 30 seconds demonstrates functional dependence

Secondary Outcome Measures

Self-efficacy scale
The self-efficacy scale (SES) is used to investigate the change in self-efficacy during stair walking in stroke patients. SES is a measure that can evaluate self-efficacy as a result of being able to successfully perform a specific action in stroke patients. The scale consists of a total of 10 items, and the item 'I am not confident in performing at all' is a 100-point scale from 1 point to 'I can do it with complete confidence' 10 points. A higher score means a higher sense of self-efficacy

Full Information

First Posted
September 23, 2022
Last Updated
December 9, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05557968
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
Active range of motion exercises. Passive range of motion exercises Balance exercises. On-ground gait training without watching videos
Arm Title
Action Observation Therapy (AO)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Therapy
Intervention Description
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
Intervention Name(s)
Action Observation Therapy (AO)
Intervention Description
The video consists of : Ascending and descending the step box. Ascending and descending the stairs in the treatment room. Holding the handrails to climb and descend the stairs inside and outside the building. Climbing and descending the stairs inside and outside the building without holding the handle. Climbing and descending the sidewalk block
Primary Outcome Measure Information:
Title
Fugel Meyer assessment scale for lower limb
Description
Lower limb subscale of Fugel-Meyer Assessment is a subscale measuring lower limb motor recovery. It examines movement, coordination, and reflex action of the hip, knee, and ankle in the supine, sitting, and standing positions. Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully). The score range is 0 to 34, with higher scores indicating better lower limb motor performance
Time Frame
week 6
Title
Berg Balance Scale
Description
The Berg Balance Scale (BBS) is a functional balance measurement and consists of 14 items(30). Each item is a 5-point ordinal scale ranging from 0 to 4, with 0 indicating an inability to complete the task entirely and 4 indicating an ability to complete the task criterion. Scores can range from 0 to 56. The higher the score, the better the postural control
Time Frame
week 6
Title
Timed Up and Down Stair Test
Description
To determine the change in stair walking ability, a timed stair test (TST) is performed. TST is a functional evaluation tool that evaluates stair walking ability in daily life. The measurement method is to measure the time it takes for the person to start climbing the stairs according to the command of the examiner and come down from the end of the stairs. One stairway used in this study is 95 cm wide, 15 cm long, and 15 cm high, for a total of 12 spaces
Time Frame
week 6
Title
Step test
Description
A step test (ST) was used to determine the change in balance ability required for stair walking. ST is an evaluation tool that examines the dynamic balance ability in the standing posture of stroke patients. The ST is a reliable measurement tool when the number of steps is counted by either experienced or inexperienced examiners by viewing videotapes. As for the measurement method, the subject stands in front of a 7.5 cm high stool 5 cm and then counts the number of times while repeatedly raising and lowering one foot as quickly as possible for 15 seconds
Time Frame
week 6
Title
Timed up and go test
Description
The Timed up and go test (TUG) is the time measured when standing up, walking straight for 3m, turning, walking back to the chair, and sitting down. Time less than 10 seconds shows functional independence, and time more than 30 seconds demonstrates functional dependence
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Self-efficacy scale
Description
The self-efficacy scale (SES) is used to investigate the change in self-efficacy during stair walking in stroke patients. SES is a measure that can evaluate self-efficacy as a result of being able to successfully perform a specific action in stroke patients. The scale consists of a total of 10 items, and the item 'I am not confident in performing at all' is a 100-point scale from 1 point to 'I can do it with complete confidence' 10 points. A higher score means a higher sense of self-efficacy
Time Frame
week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Afridi, PhD*
Phone
03325962212
Email
ayesha.afridi@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Kainat QADEER, MS NMPT*
Phone
03499377072
Email
kainatqadeer72@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Afridi, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helping hand institute of rehabilitation sciences
City
Mansehra
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sania Syed, MS NMPT*
First Name & Middle Initial & Last Name & Degree
Sania Syed, MS-(NMPT)*

12. IPD Sharing Statement

Plan to Share IPD
No

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Action Observation Therapy for Lower Limb in Stroke

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