- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05084820
Action Observation Treatment on Motor Function in Upper Limb of Patients With Chronic Stroke
Effects of Action Observation Treatment on Motor Function in Upper Limb of Patients With Chronic Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is one of the major cause of death in Pakistan and also a prime source of disability in older adults.Mirror neuron system depends on motor regions, and its dominant aspect is that,it is activated for implementation of motor activity and also for its observation. This "dual activation" characteristic of mirror neuron helps in improving the observation and execution of different actions.
aim of this study is to determine the effects of action observation treatment on motor function in upper limb of patients with chronic stroke.
An RCT will be conducted on 14 chronic stroke patients from Omar Hospital and Riphah Rehabilitation Centre Lahore. Patients will be randomly allocated into control group (n=7) and Experimental group (n=7) by lottery method. Control group will be given only conventional treatment that included stretching, strengthening, pinching, gripping, reaching and grasping exercises, while Experimental group received conventional treatment and action observation treatment 3 days/ week for 4 weeks. Treatment outcomes will be assessed on Modified Barthel Index and Fugl-Meyer Assessment for upper extremity (FMA-UE)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Fedral
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Islamabad, Fedral, Pakistan, 44000
- Riphah International University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic Stroke patients (with more than 6 months- 4 years) illness
- Patients that were able to communicate and comprehend oral instructions
- Patients with Mini Mental State Examination (MMSE) score more than 24
Exclusion Criteria:
- Patients having psychiatric histories.
- Visual and hearing impaired patients
- Patients with speech impairment
- Patients with arthritic deformities in upper limb (with or without using assistive device)
- Patients with diagnosed mental illness.
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 |
|---|---|
|
Experimental: Action observation treatment
|
Participants will watch 5 videos of motor tasks; each video is of 30 sec and watch for 4 times (i.e. for 2 minutes).
Then patient will execute the motor act, soon after the observation with an affected limb for 2 minutes, with total rest time of 5 minutes for this treatment.
Conventional treatment of muscle stretching, strengthening and ROM exercises will be given for 15 minutes including rest.
Total treatment time is 40 minutes.
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Active Comparator: conventional treatment
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conventional treatment of 40 minutes in total will be performed including Stretching (for 8-10 sec with set of 5 repetitions/ session on each side for 3 minutes total with rest), strengthening (weighted bicep curls, side arm raise and open arm movement exercises with set of 5 repetitions/ session for 9 minutes total with rest), Range of motion exercises active and passive with set of 5 repetitions/ session for 3 minutes total with rest and gripping,reaching, grasping exercises (on each side for total 25 minutes including rest) with assistance of physiotherapist
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
modified barthal index
Time Frame: 40 minutes
|
The Modified Barthel Index score was used for practical evaluation in activities of daily living.
The MBI comprises of 10 items, 6 out of 10 items scored from 0-2 points, 2 items scored from 0-3 points and other 2 items scored from 0-3 points, giving a highest total score of 20 points.
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40 minutes
|
|
Fugl-Meyer Assessment test
Time Frame: 40 minutes
|
Fugl-Meyer Assessment test for Upper extermity.to
assess level of motor impairment and its recovery after treatment.
The FMA-UE comprises of 7 times.
|
40 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: zeest hashmi, MS NMPT, Riphah International University
Publications and helpful links
General Publications
- Mao H, Li Y, Tang L, Chen Y, Ni J, Liu L, Shan C. Effects of mirror neuron system-based training on rehabilitation of stroke patients. Brain Behav. 2020 Aug;10(8):e01729. doi: 10.1002/brb3.1729. Epub 2020 Jul 1.
- Keller J, Stetkarova I, Macri V, Kuhn S, Petioky J, Gualeni S, Simmons capital ES, CyrillicD, Arthanat S, Zilber P. Virtual reality-based treatment for regaining upper extremity function induces cortex grey matter changes in persons with acquired brain injury. J Neuroeng Rehabil. 2020 Sep 12;17(1):127. doi: 10.1186/s12984-020-00754-7.
- Keci A, Tani K, Xhema J. Role of Rehabilitation in Neural Plasticity. Open Access Maced J Med Sci. 2019 May 14;7(9):1540-1547. doi: 10.3889/oamjms.2019.295. eCollection 2019 May 15.
- Habibi-Koolaee M, Shahmoradi L, Niakan Kalhori SR, Ghannadan H, Younesi E. Prevalence of Stroke Risk Factors and Their Distribution Based on Stroke Subtypes in Gorgan: A Retrospective Hospital-Based Study-2015-2016. Neurol Res Int. 2018 Jul 26;2018:2709654. doi: 10.1155/2018/2709654. eCollection 2018.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/20/0213 Hira Rehman
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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