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Action Observation Therapy Versus Mirror Therapy on Upper Limb in Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Action Observation Therapy
Mirror Therapy
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:

  • Both male and female
  • Middle cerebral artery stroke
  • 1 to 6 months of stroke onset
  • Baseline score of the Fugyl Myer Assessment is between 20 and 60 for the upper limb.
  • Modified Ashworth scale with a score of 2 Ability to follow the study instructions-Mini mental state examination (MMSE) score >25

Exclusion Criteria:

  • Participants failing to fall in this category would be excluded from the study.
  • Patients who cannot perform the active movement of the 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
  • Patient with impaired cognition

Sites / Locations

  • Helping hand institute of rehabilitation sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Action Observation Therapy

Mirror Therapy

Arm Description

The patients in the action observation therapy group will be required to observe the upper limb movements or functional actions in video clips. (i.e., the observation phase) and to execute what they had observed to the best of their ability (i.e., the execution phase). Three common categories of movements and tasks will be elected in the action observation therapy protocol based on the related literature

During the mirror therapy, the patients will be seated in front of a mirror box placed at their mid-sagittal plane. The affected arm of the participants will be placed inside the mirror box and the unaffected arm in front of the mirror. The patient will be instructed to watch the mirror reflection of the movement performed by his/her unaffected hand carefully and to imagine that the movement was performed by the affected hand.

Outcomes

Primary Outcome Measures

Fugel Meyer assessment scale for upper limb
An assessment scale for post stroke hemiplegic patients and is performance-based impairment index. This scale is having 5 domains namely Motor functioning, Sensory Functioning, Balance, Joint Range of Motion and Joint pain. I divided the motor functioning for upper extremity into 0 to 66 points and evaluates mobility, speed and coordination
Box and Block Test (BBT)
This test is used to evaluate the manual dexterity of post stroke patients. BBT is composed of wooden box with two equal compartments having 150 boxes in one compartment and patient is asked to move the boxes from one compartment to another within 60 seconds. Before starting the test an extra 15 seconds time is given to the patient for familiarization with the test. First the patient performed the activity with the healthy arm and then with the affected arm. Scoring is done on the basis of the number of boxes transferred from one compartment to another within 60 seconds
Functional Independence Measure (FIM)
The FIM is a commonly used scale for assessing the performance in basic daily activities. It contains 18 items (i.e., 13 motor and 5 cognition items), and the total score ranges from 0 to 126

Secondary Outcome Measures

Stroke Impact Scale (SIS) version 3.0
The SIS 3.0 is a stroke-specific, patient-reported questionnaire for evaluating the function, participation, and health-related quality of life of stroke survivors. The SIS 3.0 has sound psychometric properties. It consists of 59 items, and higher scores indicate better function and greater participation.

Full Information

First Posted
September 14, 2022
Last Updated
December 9, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05544747
Brief Title
Action Observation Therapy Versus Mirror Therapy on Upper Limb in Stroke
Official Title
Comparison of Action Observation Therapy Versus Mirror Therapy on Upper Limb Physical Performance and Quality of Life in 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
Stroke is a medical condition which causes the cessation of blood flow to the brain cells and results in cell death and ultimately can lead to motor disorders, perception disorders, language disorders, sensory disturbances.It is well known that stroke is the leading cause of death and one of the greatest causes of long-term motor disability in adults.The incidence of stroke is increasing day by day in low-income countries as compared to high-income countries because of the effects of not using evidence-based practice in health-related conditions in low-income countries. In the last few years, several approaches have been used for the recovery of hand dexterity after stroke. Among them, the Mirror therapy, task-oriented therapy, robot-assisted rehabilitation and action observation has gained greatest attention.Action observation training is one of the new developing rehabilitation technique that targets motor learning by the activation of mirror neurons and is the most important approach that targets the motor and functional recovery in stroke patients. In action observation training, the movements are produced because of the external stimuli in which actually the visual attention recruit the cerebellar-thalamic-cortical circuit of the brain. Action observation is based on activities of the motor neuron system and they discharge mostly in association with complex tasks as compared to simple tasks.

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
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Action Observation Therapy
Arm Type
Experimental
Arm Description
The patients in the action observation therapy group will be required to observe the upper limb movements or functional actions in video clips. (i.e., the observation phase) and to execute what they had observed to the best of their ability (i.e., the execution phase). Three common categories of movements and tasks will be elected in the action observation therapy protocol based on the related literature
Arm Title
Mirror Therapy
Arm Type
Active Comparator
Arm Description
During the mirror therapy, the patients will be seated in front of a mirror box placed at their mid-sagittal plane. The affected arm of the participants will be placed inside the mirror box and the unaffected arm in front of the mirror. The patient will be instructed to watch the mirror reflection of the movement performed by his/her unaffected hand carefully and to imagine that the movement was performed by the affected hand.
Intervention Type
Other
Intervention Name(s)
Action Observation Therapy
Intervention Description
following phases will be included in action observation therapy group: upper limb active range of motion (AROM) exercises. reaching movement or object manipulation. upper limb functional tasks.
Intervention Type
Other
Intervention Name(s)
Mirror Therapy
Intervention Description
following phases will be included in mirror therapy group: AROM exercises), reaching movement or object manipulation, and functional task practice
Primary Outcome Measure Information:
Title
Fugel Meyer assessment scale for upper limb
Description
An assessment scale for post stroke hemiplegic patients and is performance-based impairment index. This scale is having 5 domains namely Motor functioning, Sensory Functioning, Balance, Joint Range of Motion and Joint pain. I divided the motor functioning for upper extremity into 0 to 66 points and evaluates mobility, speed and coordination
Time Frame
week 6
Title
Box and Block Test (BBT)
Description
This test is used to evaluate the manual dexterity of post stroke patients. BBT is composed of wooden box with two equal compartments having 150 boxes in one compartment and patient is asked to move the boxes from one compartment to another within 60 seconds. Before starting the test an extra 15 seconds time is given to the patient for familiarization with the test. First the patient performed the activity with the healthy arm and then with the affected arm. Scoring is done on the basis of the number of boxes transferred from one compartment to another within 60 seconds
Time Frame
week 6
Title
Functional Independence Measure (FIM)
Description
The FIM is a commonly used scale for assessing the performance in basic daily activities. It contains 18 items (i.e., 13 motor and 5 cognition items), and the total score ranges from 0 to 126
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Stroke Impact Scale (SIS) version 3.0
Description
The SIS 3.0 is a stroke-specific, patient-reported questionnaire for evaluating the function, participation, and health-related quality of life of stroke survivors. The SIS 3.0 has sound psychometric properties. It consists of 59 items, and higher scores indicate better function and greater participation.
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: Both male and female Middle cerebral artery stroke 1 to 6 months of stroke onset Baseline score of the Fugyl Myer Assessment is between 20 and 60 for the upper limb. Modified Ashworth scale with a score of 2 Ability to follow the study instructions-Mini mental state examination (MMSE) score >25 Exclusion Criteria: Participants failing to fall in this category would be excluded from the study. Patients who cannot perform the active movement of the 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 Patient with impaired cognition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sania Syed, MS NMPT*
Phone
+92 321 1930855
Email
saniasyed48@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 Versus Mirror Therapy on Upper Limb in Stroke

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