- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06794749
Action Observation Therapy in Chronic Stroke
Investigation of the Effect of Action Observation Therapy Applied With Telerehabilitation Method on Upper Extremity Functions, Daily Living Activities and Quality of Life in Chronic Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is defined as a neurological picture caused by focal damage to the central nervous system due to vascular problems such as cerebral infarction or intracerebral or subarachnoid hemorrhage.
Functional impairment in the upper extremities is one of the most common sequelae in stroke patients. It significantly limits the patients' grasping-releasing functions and, consequently, their activities of daily living (ADL), such as eating - drinking, dressing, and self-care.
Action Observation Therapy (AOT), which is performed by observing simple actions frequently used in ADL and then imitating the observed actions, is a rehabilitation approach used in recent years to improve upper limb functions in the rehabilitation of stroke and various neurological diseases. It is stated that AOT reduces interhemispheric inhibition and allows the elimination of impairments in motor function and relearning of functions.
Telerehabilitation is the remote delivery of rehabilitation services through telecommunication technology. Telerehabilitation provides important advantages, such as difficulty transferring the patient to the health center, where the rehabilitation process takes a long time, travel time, and travel costs in stroke patients.
In the literature review, no study was found comparing the effect of the AOT with the telerehabilitation method and face-to-face application on the patient's upper extremity functions, activities of daily living, and quality of life in the rehabilitation of patients with chronic stroke. In addition, to our knowledge, there is no study examining the long-term effects of AOT, which has been the subject of a limited number of studies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Karabük Province
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Karabük, Karabük Province, Turkey (Türkiye), 78100
- Mustafa KAVAK
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being over 18 years of age,
- Diagnosis of left hemiparetic stroke,
- Having passed between 6-36 months since the onset of stroke,
- Being in stage 4 or 5 of the hand and stage 4, 5 or 6 of the upper extremity according to Brunnstrom staging,
- Being able to sit on a chair for 30 minutes without support (patients who scored 20 or more points in total from the Trunk Impairment Scale),
- Scoring 24 or more points from the Mini Mental Test
Exclusion Criteria:
- Not volunteering to participate in the study,
- Having spasticity (level 3 and 4 according to the Modified Ashworth Scale) that prevents grasping and releasing an object,
- Having contracture in any of the upper extremity joints on the affected side,
- Having a serious neglect disorder (scoring 21 and above on the Catherine Bergego Scale),
- Having cooperation, adaptation and behavioral disorders during the application of the tests used to obtain the data,
- Having mental impairment that prevents communication and receiving basic commands (scoring less than 24 on the Mini Mental Test)
- Having additional neurological and/or orthopedic problems that may affect motor performance and sitting balance
- Having advanced vision and hearing problems (if any, these problems have not been corrected with assistive devices such as glasses, lenses, hearing aids, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Action Observation Therapy
Patients received action observation therapy in addition to general physiotherapy via telerehabilitation method, 3 days a week for 5 weeks.
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Patients received general physiotherapy in addition to action observation therapy (AOT) via telerehabilitation method for 5 weeks, 3 days a week.
AOT was applied to patients as a single session per day and lasted 30 minutes.
General physiotherapy session was applied face to face for 45 minutes.
|
|
Active Comparator: Control
Patients received general physiotherapy in addition to face-to-face action observation treatment 3 days per week for 5 weeks.
|
Patients received general physiotherapy in addition to action observation therapy (AOT) via face-to-face telerehabilitation method for 5 weeks, 3 days a week.
AOT was applied to patients as a single session per day and lasted 30 minutes.
General physiotherapy session was applied face-to-face for 45 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spasticity
Time Frame: Baseline
|
Spasticity will assessed using the Modified Ashworth Scale.
As the score increases, spasticity increases.
The minimum score for this scale is 1 and the maximum score is 5.
|
Baseline
|
|
Stage of hemiplegia
Time Frame: Baseline
|
"Brunnstrom Hemiplegia Recovery Staging" will be used to determine the hemiplegic stage of the patients.
This scale is scored between 1 and 6.
As the score increases, the patient improves.
|
Baseline
|
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Motor function
Time Frame: Baseline, five week later (after intervention), 3 months later
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The "Fugl-Meyer Upper Extremity Motor Assessment Scale" will be used to evaluate upper extremity motor functions.
This scale ranges from 0 to 66 points.
As the score increases, motor function improves.
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Baseline, five week later (after intervention), 3 months later
|
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Dominant side
Time Frame: Baseline
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The "Edinburgh Hand Preference Test" will be used to determine the dominant side used by the patient in daily life.
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Baseline
|
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Trunk Impairment
Time Frame: Baseline
|
"Trunk Impairment Scale" will be used to evaluate trunk impairment in stroke patients.
The maximum score that can be obtained from the scale is 23 points.
A low score indicates poor performance, a high score indicates good performance
|
Baseline
|
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Upper extremity function
Time Frame: Baseline, five week later (after intervention), 3 months later
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Evaluation of upper extremity functions (hand-arm) and motor speed will be done with the "Nine-Hole Peg Test".
Function decreases as the time spent for the test increases.
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Baseline, five week later (after intervention), 3 months later
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Functional Independence
Time Frame: Baseline, five week later (after intervention), 3 months later
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Evaluation of upper extremity functions will be done with the "Nine-Hole Peg Test".
Function decreases as the time spent on the test increases.
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Baseline, five week later (after intervention), 3 months later
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Cognitif Function
Time Frame: Baseline
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Mini Mental Test will be used to evaluate cognitive functions.
In the evaluation, 24-30 points indicate that cognitive functions are normal, 18-23 points indicate mild cognitive impairment, and 17 points and below indicate that cognitive status is severely affected.
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Baseline
|
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Neglect
Time Frame: Baseline
|
The Catherine Bergego Scale will be used to assess the impact of unilateral neglect after stroke on activities of daily living.
1-10 indicates mild neglect, 11-20 indicates moderate neglect, and 21-30 indicates severe neglect.
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Baseline
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Life Quality
Time Frame: Baseline, five week later (after intervention), 3 months later
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The Stroke Specific Quality of Life Scale will be used to assess the quality of life of individuals with stroke.
The higher the total score, the better the quality of life of the individual with stroke.
This scale is scored between 49-245.As the score increases, the quality of life increases.
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Baseline, five week later (after intervention), 3 months later
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mustafa KAVAK, MsC, Karabuk University
Publications and helpful links
General Publications
- Friberg H, Lundberg D, Nilstun T. [Ethical views on resuscitation. Formal guidelines for do-not-resuscitate orders in Sweden]. Lakartidningen. 1994 Oct 19;91(42):3787-9. No abstract available. Swedish.
- Cortes-Gallegos V, Sojo Aranda I, Gio Pelaez RM. Disturbing the light-darkness pattern reduces circulating testosterone in healthy men. Arch Androl. 1998 Mar-Apr;40(2):129-32. doi: 10.3109/01485019808987935.
Helpful Links
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
- Karabuk-01
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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