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Clinical Trials/NCT06501014
NCT06501014
Completed
N/A

Investigating the Effectiveness of Action Observation Therapy Applied in Addition to Conventional Treatment in Stroke Patients

KTO Karatay University1 site in 1 country30 target enrollmentJuly 16, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
KTO Karatay University
Enrollment
30
Locations
1
Primary Endpoint
2 minute walk test
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 16, 2024
End Date
September 30, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
KTO Karatay University
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

2 minute walk test

Time Frame: The evaluation will be applied at the baseline and after study completion, an average of 2 months.

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.

Fugl-Meyer Assessment

Time Frame: The evaluation will be applied at the baseline and after study completion, an average of 2 months.

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.

Berg Balance Scale

Time Frame: The evaluation will be applied at the baseline and after study completion, an average of 2 months.

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.

Study Sites (1)

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