- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06501014
Effectiveness of Action Observation Therapy in Stroke Patients
Investigating the Effectiveness of Action Observation Therapy Applied in Addition to Conventional Treatment in Stroke Patients
The goal of this clinical trial is to learn the effectiveness of action observation therapy in patients with stroke.
The main questions it aims to answer are:
Is action observation therapy an effective method in stroke patients?
Researchers will compare the results of two action observation-based exercises (home program) with conventional exercise to see whether action observation therapy works in the rehabilitation of stroke patients.
Participants:
Participants in one group will do action observation-based exercise (home plus conventional exercise for 24 sessions, Patients in the control group will only undergo conventional exercise in addition to routine treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individuals with chronic stroke will be included in this study. Participants will be randomly divided into two groups, and patients in both groups will continue their routine treatments.
Patients in the control group will only undergo conventional exercise. Patients in the study group will be given a home exercise program in addition to conventional treatment. However, patients will be asked to first watch the video of each exercise in this program and then perform the exercise.
Patients will be asked to perform the exercises 3 days a week for 8 weeks. Evaluations will be made twice, before the exercise program application begins and after the sessions are completed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Konya, Turkey (Türkiye)
- KTO Karatay University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Stroke patients in the chronic phase (more than 6 months have passed since the stroke)
- Patients over 40 years of age
- Patients who can stand and walk independently (including those using walking aids)
Exclusion Criteria:
- Additional disease (neurological, orthopedic, etc.) that may affect motor performance and balance.
- Patients with communication problems
- Patients with mental problems (mini-mental test score <23)
- Patients aged 85 and over
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-Experimental Group
Patients will be asked to watch the exercises before doing them.
For each exercise, patients will first watch the relevant video and do the exercise after the video ends.
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Patients will be asked to watch the exercises before doing them.For each exercise, patients will first watch the relevant video and do the exercise after the video ends.
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Active Comparator: Conventional Exercises-Control Group
Patients will be subjected to conventional exercise only.
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Patients will be subjected to conventional exercise only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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2 minute walk test
Time Frame: The evaluation will be applied at the baseline and after study completion, an average of 2 months.
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Patients will be asked to walk 30 meters long on a flat surface for 2 minutes.
When the time is up, the distance the patient can walk will be recorded.
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The evaluation will be applied at the baseline and after study completion, an average of 2 months.
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Berg Balance Scale
Time Frame: The evaluation will be applied at the baseline and after study completion, an average of 2 months.
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The Berg Balance Scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of funcion.
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The evaluation will be applied at the baseline and after study completion, an average of 2 months.
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Fugl-Meyer Assessment
Time Frame: The evaluation will be applied at the baseline and after study completion, an average of 2 months.
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The FMA motor assessments for the lower extremity (minimum score:0 and maximum score 34 points) will be applied.
A higher score means the patient's motor movements are better.
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The evaluation will be applied at the baseline and after study completion, an average of 2 months.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Osman Karaca, PhD, KTO Karatay University
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
- KaratayUO3
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
product manufactured in and exported from the U.S.
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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