Telerehabilitation Based Motor Imagery and Action Observation Training in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Effect of Telerehabilitation-Based Motor Imagery and Action Observation Training on Balance and Functional Mobility in Multiple Sclerosis: Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295601
• Other study ID #: 2024/5591
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: August 15, 2025

Study information

• Verified date: March 2024
• Source: Inonu University
• Contact: Busra CANDIRI
• Phone: +9005073780717
• Email: candiri_17[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life.

Description:

The study population was participants with relapsing remitting multiple sclerosis. The traditional rehabilitation program consists of a joint treatment in which lower extremity strengthening and balance exercises are carried out synchronously for the experimental and control groups. Motor imagery and action observation therapy based on telerehabilitation of certain movements will be applied to the experimental group. All treatments will be carried out online via the zoom program. The treatment program will be applied 3 times a week for 6 weeks. Evaluations will be made before and after the treatment program. Assessments include balance, lower extremity muscle strength and functional mobility, fatigue, and quality of life.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being diagnosed with mulltiple sclerosis according to the McDonald criteria

• Expanded Disability Status Scale<5.5,

• Being between the ages of 18-65,

• Mini mental test score>24,

• Have a phone that can adapt to participating in a video call

Exclusion Criteria:

• Having another additional neurological disease that may cause balance and coordination disorders,

• Receiving physical therapy in the last 6 months,

• Having an attack in the last 3 months

• Refusal to participate in the study.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Traditional rehabilitation
The program consists of a joint treatment in which lower extremity strengthening and balance exercises are carried out synchronously. The program will include a total of 5 minutes of warm-up, 5 minutes of cool-down and 30 minutes of exercises related to the program. The difficulty of the program will increase by changing the number of exercises and increasing the weight in strengthening exercises. Progress in balance and coordination exercises will vary by changing the ground, increasing the standing time, and keeping the eyes open and closed.
• Action observation therapy and motor imagery
In the experimental group, in addition to traditional telerehabilitation, action observation and motor imagery of 4 exercises will be performed in each session. A video will be prepared for 4 exercises. Then, the participant will perform 2 minutes of action observation of each movement, followed by 1 minute of motor imagery. In addition to the traditional telerehabilitation program, a 12-minute combination of action observation and motor imagery will be performed in each session. Exercises will be changed every two weeks, gradually increasing the difficulty.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale	Berg Balance Scale consists of a total of 14 items. Evaluation for each stage is made between 0-4. Higher score indicates better functional balance performance	Baseline
Primary	Berg Balance Scale	Berg Balance Scale consists of a total of 14 items. Evaluation for each stage is made between 0-4. Higher score indicates better functional balance performance	6 weeks after baseline
Primary	Muscle strength and functional mobility	The participant will be asked to sit and stand up from a standard chair between 42-45 cm, with hands crossed on the chest, without support, 5 times. The time will be stopped when the participant completes the last sitting. It will be recorded in seconds.	Baseline
Primary	Muscle strength and functional mobility	The participant will be asked to sit and stand up from a standard chair between 42-45 cm, with hands crossed on the chest, without support, 5 times. The time will be stopped when the participant completes the last sitting. It will be recorded in seconds.	6 weeks after baseline
Secondary	Fatigue Severity Scale	This scale consists of a total of 9 items and is scored between 0-7. >4 points indicate fatigue	Baseline
Secondary	Fatigue Severity Scale	This scale consists of a total of 9 items and is scored between 0-7. >4 points indicate fatigue	6 weeks after baseline
Secondary	Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire	The scale consists of 31 questions in 9 dimensions (subscales). The index score is calculated as the average of these subscale scores. All 9 dimensions and the index score are linearly transformed and standardized on a scale from 0 to 100; where 0 indicates the worst possible level of quality of life and 100 indicates the best level.	Baseline
Secondary	Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire	The scale consists of 31 questions in 9 dimensions (subscales). The index score is calculated as the average of these subscale scores. All 9 dimensions and the index score are linearly transformed and standardized on a scale from 0 to 100; where 0 indicates the worst possible level of quality of life and 100 indicates the best level.	6 weeks after baseline