Action Observation and Motor Imagery Therapy in Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Sham action observation and motor imagery therapy for rehabilitation; Other: Action observation and motor imagery therapy for rehabilitation

• Registration Number: NCT06166862
• Lead Sponsor: Karamanoğlu Mehmetbey University

Brief Summary

In recent years, motor imagery (MI) and action observation (AO) therapy strategies have been used in rehabilitation programs to increase motor learning in stroke. Visuomotor training strategies such as AO and MI therapy rely on the activity of the mirror neuron system to facilitate motor re-learning. Mirror neurons are activated during the performance of goal-directed actions, also when observing the same action and visualizing the action in the mind.

This clinical trial aims to test whether the application of AO and MI treatment in stroke in addition to conventional rehabilitation programs has an additional effect on motor recovery, activities of daily living, and quality of life.

Detailed Description

Stroke is one of the most common neurological disorders that causes chronic disability in adulthood. Stroke-related neurological dysfunction causes impairment in motor and sensory skills and limitation in the ability to perform daily living activities, resulting in decreased independence of patients. This process causes significant impairment in the quality of life of stroke patients.

In recent years, motor imagery (MI) and action observation (AO) therapy strategies have been used in rehabilitation programs to increase motor learning in stroke. Visuomotor training strategies such as AO and MI therapy rely on the activity of the mirror neuron system to facilitate motor re-learning. Mirror neurons are activated during the performance of goal-directed actions, also when observing the same action and visualizing the action in the mind.

This clinical trial aims to test whether the application of AO and MI treatment in stroke in addition to conventional rehabilitation programs has an additional effect on motor recovery, activities of daily living, and quality of life.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study Start: 2023-12-12
• Study First Posted: 2023-12-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patients who had a stroke in the last year
• Functional Ambulation Classification score 2-5

Exclusion Criteria

• Patients who have had repeated strokes
• Patients with neglect
• Patients with cognitive dysfunction (those who cannot follow simple verbal instructions)
• Patients with severe hearing problems
• Patients with severe vision problems
• Patients with additional musculoskeletal system pathology that will affect physical performance (such as amputation, severe joint mobility limitation, peripheral nerve damage)
• Patients with uncontrolled hypertension and diabetes mellitus
• Patients with a history of symptomatic lung disease (such as asthma, chronic obstructive pulmonary disease, emphysema)
• Patients with a history of symptomatic cardiac disease (such as coronary artery disease, arrhythmia, heart failure)
• Patients with peripheral artery disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham action observation and motor imagery therapy for rehabilitation	Sham action observation and motor imagery therapy for rehabilitation	Sham comparator for action observation and motor imagery therapy for rehabilitation in stroke patients in addition to conventional rehabilitation programs.
Action observation and motor imagery therapy for rehabilitation	Action observation and motor imagery therapy for rehabilitation	Action observation and motor imagery therapy for rehabilitation in stroke patients in addition to conventional rehabilitation programs.

Primary Outcome Measures

Name	Time	Method
The difference in the scores of the Brunnstrom stages between pre- and post-rehabilitation assessments	6 weeks	Univariate statistical analyses will be performed to calculate differences in the scores of the Brunnstron stages between pre- and post-rehabilitation assessments.; Brunnstrom staging assesses the motor recovery process of the hemiplegic patient in 6 stages (Stages 1 to 6). Upper extremity, lower extremity, and hand are evaluated separately. Higher stages indicate better motor function.
The difference in the scores of the Fugl-Meyer Assessment between pre- and post-rehabilitation assessments	6 weeks	Univariate statistical analyses will be performed to calculate differences in the scores of the Fugl-Meyer Assessment between pre- and post-rehabilitation assessments.; The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The motor domain is used in this study, which includes items assessing movement, coordination, and reflex action of the upper and lower extremities. Motor score ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.

Secondary Outcome Measures

Name	Time	Method
The difference in the scores of the Barthel Index between pre- and post-rehabilitation assessments	6 weeks	Univariate statistical analyses will be performed to calculate differences in the scores of the Barthel Index between pre- and post-rehabilitation assessments.; The Barthel Index measures the functional independence of a person in mobility and activities of daily living. The index yields a total score out of 100 (0 to 100). The higher the score, the greater the degree of functional independence.
The difference in the scores of the Stroke-Specific Quality of Life Scale between pre- and post-rehabilitation	6 weeks	Univariate statistical analyses will be performed to calculate differences in the scores of the Stroke-Specific Quality of Life Scale between pre- and post-rehabilitation assessments.; Stroke Specific Quality of Life Scale assesses health-related quality of life specific to stroke survivors. It consists of a total of 49 items and the total score ranges from 49-245. Higher scores indicate better functioning.

Trial Locations

Locations (1)

Karaman Training and Research Hospital; 🇹🇷 Karaman, Turkey