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Clinical Trials/NCT06166862
NCT06166862
Recruiting
Not Applicable

Effect of Action Observation and Motor Imagery Therapy on Balance, Functional Status and Quality of Life in Stroke, Randomized Controlled Trial

Karamanoğlu Mehmetbey University1 site in 1 country56 target enrollmentDecember 12, 2023
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Karamanoğlu Mehmetbey University
Enrollment
56
Locations
1
Primary Endpoint
The difference in the scores of the Brunnstrom stages between pre- and post-rehabilitation assessments
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2023
End Date
June 1, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karamanoğlu Mehmetbey University
Responsible Party
Principal Investigator
Principal Investigator

Yurdagül Bahran Muştu

M.D., Principal investigator

Karamanoğlu Mehmetbey University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The difference in the scores of the Brunnstrom stages between pre- and post-rehabilitation assessments

Time Frame: 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

Time Frame: 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 Outcomes

  • The difference in the scores of the Barthel Index between pre- and post-rehabilitation assessments(6 weeks)
  • The difference in the scores of the Stroke-Specific Quality of Life Scale between pre- and post-rehabilitation(6 weeks)

Study Sites (1)

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