- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06027125
Long Term Effects of Action Observation Therapy and Mirror Therapy on Upper Limb Functions
Long Term Effects of Action Observation Therapy and Mirror Therapy on Upper Limb Functional and Fine Motor Outcomes After Subacute Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Gujrat, Punjab Province, Pakistan, 50700
- Mid city Hospital Gujrat
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Fugel Meyer assessment of upper limb
Time Frame: 4,5,6,7,8 week
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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.
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4,5,6,7,8 week
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Functional Independence Measure
Time Frame: 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.
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4,5,6,7,8 week
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Short form of the Stroke Impact Scale (SF-SIS)
Time Frame: 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.
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4,5,6,7,8 week
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Wolf motor function test
Time Frame: 4,5,6,7,8 week
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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:
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4,5,6,7,8 week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayesha Bashir, MS, Riphah International University
Publications and helpful links
General Publications
- Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Centers for Disease Control and Prevention (CDC). Prevalence of stroke--United States, 2006-2010. MMWR Morb Mortal Wkly Rep. 2012 May 25;61(20):379-82.
- Hewer RL. Stroke rehabilitation. Cerebral Arterial Disease Edinburgh, Scotland, Churchill Livingstone. 1976:262-80
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01666 Kainat Basit
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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