Effectiveness of Action Observation Therapy in Stroke Patients

Not Applicable

Recruiting

• Conditions: Stroke; Rehabilitation
• Interventions: Other: Conventional Exercises-Control Group; Other: Action Observation Therapy-Experimental Group

• Registration Number: NCT06501014
• Lead Sponsor: KTO Karatay University

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 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 for 24 sessions, while participants in the other group will do conventional exercise.

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.

In addition to routine treatment, patients in the control group will be given an exercise program explained verbally and/or through pictures. Patients in the study group will be given a home exercise program in addition to routine 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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Study Start: 2024-07-16
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Primary Completion: 2025-07-30
• Study Completion: 2025-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Stroke patients in the chronic phase (more than 6 months have passed since the stroke)
• Patients over 18 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 aged 85 and over

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Exercises-Control Group	Conventional Exercises-Control Group	Patients will be asked to perform exercises that are described verbally and/or shown through pictures.
Action Observation Therapy-Experimental Group	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.

Primary Outcome Measures

Name	Time	Method
Spasticity Assessment	The evaluation will be applied at the baseline and after study completion, an average of 2 months.	Modified Modified Ashworth Scale (MMAS) will be applied to evaluate muscle tone in lower extremity muscles.Minimum score:0 and maximum score is 4 for every muscle/muscle group. In this study, whether the Matthew effect makes a difference in writing skills and the effects of sensoriomotor parameters on writing were investigated. The results revealed that the Matthew effect caused a significant difference in writing skills. The writing speed of individuals in the disadvantaged group was found to be significantly lower than that of the advantaged group. The results of the part of the study related to sensoriomotor parameters are; It showed that the increase in PFT-proprioception and lateral grip strength positively affected the writing speed, while the increase in gross grip strength negatively affected the writing speed.; While a low score indicates that the severity of spasticity is less, a high score indicates that the severity of spasticity is increased.
2 minute walk test	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.
Berg Balance Scale	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.
Fugl-Meyer Assessment	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.
Muscle Strength Testing	The evaluation will be applied at the baseline and after study completion, an average of 2 months.	Handheld dynamometer will be used for lower extremity muscle strength evaluation.

Trial Locations

Locations (1)

KTO Karatay University; 🇹🇷 Konya, Turkey