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

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 focused on measuring Action observation therapy , Mirror therapy

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mid city Hospital GujratRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Action Observation Therapy group

Mirror Therapy Group

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.

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.

Outcomes

Primary Outcome Measures

Fugel Meyer assessment of upper limb
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
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)
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
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

Secondary Outcome Measures

Full Information

First Posted
August 31, 2023
Last Updated
August 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06027125
Brief Title
Long Term Effects of Action Observation Therapy and Mirror Therapy on Upper Limb Functions
Official Title
Long Term Effects of Action Observation Therapy and Mirror Therapy on Upper Limb Functional and Fine Motor Outcomes After Subacute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 15, 2024 (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
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Action observation therapy , Mirror therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Action Observation Therapy group
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.
Arm Title
Mirror Therapy Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Action observation Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mirror Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugel Meyer assessment of upper limb
Description
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.
Time Frame
4,5,6,7,8 week
Title
Functional Independence Measure
Description
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.
Time Frame
4,5,6,7,8 week
Title
Short form of the Stroke Impact Scale (SF-SIS)
Description
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.
Time Frame
4,5,6,7,8 week
Title
Wolf motor function test
Description
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
Time Frame
4,5,6,7,8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Bashir
Phone
03335256920
Email
ayesha.bashir@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Bashir, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid city Hospital Gujrat
City
Gujrat
State/Province
Punjab
ZIP/Postal Code
50700
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayesha Bashir, MSNMPT
Phone
03335256920
Email
ayesha.bashir@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Zhu M-H, Wang J, Gu X-D, Shi M-F, Zeng M, Wang C-Y, et al. Effect of action observation therapy on daily activities and motor recovery in stroke patients. International journal of nursing sciences. 2015;2(3):279-82
Results Reference
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PubMed Identifier
23287316
Citation
Bhasin A, Padma Srivastava MV, Kumaran SS, Bhatia R, Mohanty S. Neural interface of mirror therapy in chronic stroke patients: a functional magnetic resonance imaging study. Neurol India. 2012 Nov-Dec;60(6):570-6. doi: 10.4103/0028-3886.105188.
Results Reference
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PubMed Identifier
25416737
Citation
Harmsen WJ, Bussmann JB, Selles RW, Hurkmans HL, Ribbers GM. A Mirror Therapy-Based Action Observation Protocol to Improve Motor Learning After Stroke. Neurorehabil Neural Repair. 2015 Jul;29(6):509-16. doi: 10.1177/1545968314558598. Epub 2014 Nov 21.
Results Reference
background
PubMed Identifier
19074686
Citation
Dohle C, Pullen J, Nakaten A, Kust J, Rietz C, Karbe H. Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):209-17. doi: 10.1177/1545968308324786. Epub 2008 Dec 12.
Results Reference
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PubMed Identifier
32103968
Citation
Gandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.
Results Reference
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PubMed Identifier
24778380
Citation
Buccino G. Action observation treatment: a novel tool in neurorehabilitation. Philos Trans R Soc Lond B Biol Sci. 2014 Apr 28;369(1644):20130185. doi: 10.1098/rstb.2013.0185. Print 2014.
Results Reference
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PubMed Identifier
22235059
Citation
Franceschini M, Ceravolo MG, Agosti M, Cavallini P, Bonassi S, Dall'Armi V, Massucci M, Schifini F, Sale P. Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity. A randomized clinical trial. Neurorehabil Neural Repair. 2012 Jun;26(5):456-62. doi: 10.1177/1545968311427406. Epub 2012 Jan 10.
Results Reference
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PubMed Identifier
32377266
Citation
Hsieh YW, Lin YH, Zhu JD, Wu CY, Lin YP, Chen CC. Treatment Effects of Upper Limb Action Observation Therapy and Mirror Therapy on Rehabilitation Outcomes after Subacute Stroke: A Pilot Study. Behav Neurol. 2020 Jan 2;2020:6250524. doi: 10.1155/2020/6250524. eCollection 2020.
Results Reference
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PubMed Identifier
21571152
Citation
Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
Results Reference
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PubMed Identifier
18295613
Citation
Yavuzer G, Selles R, Sezer N, Sutbeyaz S, Bussmann JB, Koseoglu F, Atay MB, Stam HJ. Mirror therapy improves hand function in subacute stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2008 Mar;89(3):393-8. doi: 10.1016/j.apmr.2007.08.162.
Results Reference
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PubMed Identifier
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Citation
Feigin V, Carter K, Hackett M, Barber PA, McNaughton H, Dyall L, Chen MH, Anderson C; Auckland Regional Community Stroke Study Group. Ethnic disparities in incidence of stroke subtypes: Auckland Regional Community Stroke Study, 2002-2003. Lancet Neurol. 2006 Feb;5(2):130-9. doi: 10.1016/S1474-4422(05)70325-2.
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Citation
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Results Reference
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Citation
Hewer RL. Stroke rehabilitation. Cerebral Arterial Disease Edinburgh, Scotland, Churchill Livingstone. 1976:262-80
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Long Term Effects of Action Observation Therapy and Mirror Therapy on Upper Limb Functions

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