Action Observation and Motor Imagery Therapy in Stroke

NCT06166862 | Recruiting

• 1 other identifier: 09-2023/02
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• The difference in the scores of the Fugl-Meyer Assessment between pre- and post-rehabilitation assessments

  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.

  6 weeks

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

  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.

  6 weeks

Secondary Outcomes (2)

• 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 Arms (2)

Action observation and motor imagery therapy for rehabilitation

EXPERIMENTAL

Action observation and motor imagery therapy for rehabilitation in stroke patients in addition to conventional rehabilitation programs.

Other: Action observation and motor imagery therapy for rehabilitation

Sham action observation and motor imagery therapy for rehabilitation

SHAM COMPARATOR

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

Other: Sham action observation and motor imagery therapy for rehabilitation

Interventions

Action observation and motor imagery therapy for rehabilitation OTHER

Action observation; Patients will watch some exercises accompanied by music from a previously prepared video for 10 minutes. Exercises include 8-10 repetitions of abduction-adduction, horizontal abduction-adduction, flexion-extension and supination-pronation movements for the upper extremity, and stepping, forward-backward stepping, side stepping and ankle dorsiflexion movements for the lower extremity. Motor imagery training; Patients will be asked to visualize the actions they watched in their minds for 10 minutes. Then the patients will watch the video again and will be asked to perform the exercises while watching.

Action observation and motor imagery therapy for rehabilitation

Sham action observation and motor imagery therapy for rehabilitation OTHER

Sham action observation; Patients will watch a video consisting of static nature photographs for 10 minutes with the same music. Sham motor imaginary; Patients will think about the video they watched for 10 minutes. Then, they will watch another video in which the exercises are performed only once, and they will be asked to do the exercises. They will be given enough time to do 8-10 repetitions.

Sham action observation and motor imagery therapy for rehabilitation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead
• Karaman Training and Research Hospital: collaborator

Study Sites (1)

Karaman Training and Research Hospital

Karaman, Karaman, 70200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yurdagul Bahran Mustu, MD.

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yurdagul Bahran Mustu, MD.

CONTACT

+90 506 209 76 72; yurdagulbahran@gmail.com

Aynur Basaran, MD, Prof.

CONTACT

aynurbasaran@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Principal investigator

Model Details: Prospective randomized controlled study

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

TU (1)