Long Term Effects of Action Observation Therapy and Mirror Therapy on Upper Limb Functions

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06027125

Collaborator

(none)

Enrollment

Location

Arms

10.5

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There will be a long term effects of action observation therapy and mirror therapy on upper limb functional outcomes after subacute stroke.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: Action observation Therapy Other: Mirror Therapy	N/A

Detailed Description

However, no study is conducted to check the retention rate of both therapies. My study will check the retention rate of these interventions in stroke. If we are able to know long lasting effects of this particular regime, we can incorporate this cost-effective intervention into our clinical setups for stroke rehabilitation.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Long Term Effects of Action Observation Therapy and Mirror Therapy on Upper Limb Functional and Fine Motor Outcomes After Subacute Stroke

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Feb 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Action Observation Therapy group 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.	Other: Action observation Therapy The patients in the AOT group will be required to observe the upper limb movements or functional actions in video clips and to execute what they had observed to the best of their ability.
Experimental: Mirror Therapy Group During the mirror therapy, the patients were seated in front of a mirror box placed at their midsagittal plane. The affected arm of the participants was placed inside the mirror box, and the unaffected arm was in front of the mirror. The patient was 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.	Other: Mirror Therapy The patients will be seated in front of a mirror box placed at their midsagittal plane to perform the movements. The affected arm of the participants was placed inside of the mirror box, and the unaffected arm was infront ofthe mirror.

Arm

Intervention/Treatment

Experimental: Action Observation Therapy group

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.

Other: Action observation Therapy

The patients in the AOT group will be required to observe the upper limb movements or functional actions in video clips and to execute what they had observed to the best of their ability.

Experimental: Mirror Therapy Group

During the mirror therapy, the patients were seated in front of a mirror box placed at their midsagittal plane. The affected arm of the participants was placed inside the mirror box, and the unaffected arm was in front of the mirror. The patient was 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.

Other: Mirror Therapy

The patients will be seated in front of a mirror box placed at their midsagittal plane to perform the movements. The affected arm of the participants was placed inside of the mirror box, and the unaffected arm was infront ofthe mirror.

Outcome Measures

Primary Outcome Measures

Fugel Meyer assessment of upper limb [4,5,6,7,8 week]
A three-point ordinal scale is used to measure impairments of volitional movement with grades ranging from 0 (item cannot be performed) to 2 (item can be fully performed). Specific descriptions for performance accompany individual test items. Subtests exist for UE function, LE function, balance, sensation, ROM, and pain. The cumulative test score for all components is 226 with availability of specific subtest scores (e.g., UE maximum score is 66, LE score 34; balance score 14). This instrument has good construct validity and high reliability (r =0.99) for determining motor function and balance. Quantifiable outcome data allow this instrument to be accurately used for research purposes (a gold standard) and document recovery over time. The instrument requires an estimated 30 to 40 minutes to administer.
Functional Independence Measure [4,5,6,7,8 week]
The FIM instrumentIncludes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. Is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.
Short form of the Stroke Impact Scale (SF-SIS) [4,5,6,7,8 week]
The eight items determined from the SIS 3.0 for the SF-SIS by MacIsaac et al.For this reason, we refrained from a renewed process of translation and intercultural adaptation of these eight questions. As with the SIS 2.0, the rating is based on a 5-point Likert scale (1-5 points). The raw sum score of the eight questions with a range from 8 to 40 points is converted into an interval-scaled total index of 0-100 points, the SF-SIS index. Higher scores indicate a better quality of life.
Wolf motor function test [4,5,6,7,8 week]
The Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks.1 The tasks are arranged in order of complexity, progress from proximal to distal joint involvement, test total extremity movement and movement speed, and require few tools and minimal training for test execution. The present study establishes the reliability and validity of the WMFT (Assessing Wolf Motor Function Test as Outcome Measure for Research in Patients After Stroke.) The original version consisted of 21 items; the widely used version of the WMFT consists of 17 items Composed of 3 parts: Time Functional ability Strength

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Both male and female
1 to 6 months since unilateral stroke onset
Age between 40 and 70 years.
Baseline score of the FMA motor score between 20 and 40
Ability to follow the study instructions according to Montreal cognitive scale and score should be >24.

Exclusion Criteria:

Patients with depression who will be unable to cooperate during treatment and Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation
Visual and auditory abnormalities
Major medical problems or comorbidities that influenced the usage of the upper limbs or caused severe pain.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mid city Hospital Gujrat	Gujrat	Punjab	Pakistan	50700

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Ayesha Bashir, MS, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT06027125

Other Study ID Numbers:

REC/00789 Kainat Basit

First Posted:

Sep 7, 2023

Last Update Posted:

Sep 7, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Action observation therapy , Mirror therapy

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Sep 7, 2023