Investigation of the Effects of Technology Supported Different Physiotherapy Approaches on Patients With Multiple Sclerosis

NCT ID: NCT04891341

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2022-07-17

Brief Summary

Multiple Sclerosis (MS) is an autoimmune disease characterized by chronic inflammation, demyelination and axonal loss of the central nervous system. The etiology of the disease is not known exactly and possible causes are; genetic, vitamin D deficiency, viral, environmental and autoimmune factors have been identified. Common findings of MS are in the literature; sensory, visual problems, fatigue, urinary retention / incontinence, motor problems (inability to walk, upper extremity skills, coordination and balance problems), cognitive deficits, tone, speech and swallowing disorders. In the rehabilitation of MS; It is seen that balance, coordination, strengthening, aerobic and neurodevelopmental exercise methods are used and these approaches have reached moderate / high level evidence in the literature. Task-oriented circuit therapy(TOECT), one of the current neurophysiology-based approaches; It is a motor learning-based exercise approach based on the theory of dynamic systems, one of the theories of motion control, aiming at the acquisition of skills for a specific functional activity. When the existing studies are examined, it has been determined that there are a limited number of randomized controlled studies examining the effects of TOECT and that sufficient evidence cannot be obtained with these studies. In previous studies, it has been observed that standardization of exercise approaches applied to the control group could not be achieved and the control groups generally included applications that could create passive or effect summation compared to the experimental groups. In addition, in the literature, TOECT, which includes rehabilitation games to be applied in the form of station training, in MS patients; There is no randomized controlled study examining the effects on balance, walking, fatigue, trunk and upper extremity functions and kinematics. In this direction, the purpose of the research is; To examine the effects of technology-supported TOECT and technology-supported home program applied as station training on walking, quality of life, fatigue, balance, trunk and upper extremity functions of patients with MS, using kinematic and clinical methods. Volunteers who agree to participate in the study will be divided into two groups by the block randomization method. Both groups will receive exercise training 3 sessions per week (24 sessions in total) for 8 weeks. Evaluations will be made before and after 8 weeks treatment

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Technology Supported Task-Oriented Circuit Therapy Group

Ten workstations, which are frequently used in the literature and determined according to the clinical experience of the research team, have been created. Each workstation will be applied for a total of 1 hour, in the form of 5 minutes of training and 1 minute of rest.

Group Type: EXPERIMENTAL

Technology Supported Task-Oriented Circuit Training

Intervention Type: OTHER

Ten workstations, which are frequently used in the literature and determined according to the clinical experience of the research team, have been created. Each workstation will be applied for a total of 1 hour, in the form of 5 minutes of training and 1 minute of rest.

1. Sit to stand

2. Standing and trunk training

3. Standing and lower limb training

4. Stepping

5. Walking

6. Walking with object manipulation

7. Climbing and descending stairs

8. Unilateral upper extremity activity training (VR)

9. Bilateral upper extremity activity training (VR)

10. Upper extremity reaction time training (VR) Virtual reality games will be played using the USE-IT intelligent physiotherapy game system. The system offers unilateral, bilateral and bimanual upper extremity training to individuals with a 55 inch touch screen and 7 computer games (balloon popping, car washing, plumbing, arithmetic, apartment, drum and matching).

Home-based Telerehabilitation Group

To the telerehabilitation group; A home program consisting of strengthening, balance and coordination exercises determined according to the needs of volunteers with MS will be given. A session will be applied in the home program under the guidance of a physiotherapist. The exercise will take 1 hour. The exercise participation status of the patient will be monitored with a mobile (smartphone) application. Exercises will be constantly updated according to the needs of the patient, the updated exercises will be sent to the mobile application via video, and the patient will be able to communicate with the physiotherapist via video conference whenever he / she wishes. Progress and complication of the treatment program will be achieved by increasing the weights used, changing the ground characteristics and support surface during balance exercises and increasing the complexity of coordination exercises.

Group Type: ACTIVE_COMPARATOR

Home-based Telerehabilitation

Intervention Type: OTHER

Strengthening, balance and coordination exercises will be sent to the participants via a mobile application. Patients will do the exercises at home and send a notification to their physiotherapist. Intervention will be applied for 1 hour, 3 days a week for 8 weeks.

Interventions

Technology Supported Task-Oriented Circuit Training

Ten workstations, which are frequently used in the literature and determined according to the clinical experience of the research team, have been created. Each workstation will be applied for a total of 1 hour, in the form of 5 minutes of training and 1 minute of rest.

1. Sit to stand

2. Standing and trunk training

3. Standing and lower limb training

4. Stepping

5. Walking

6. Walking with object manipulation

7. Climbing and descending stairs

8. Unilateral upper extremity activity training (VR)

9. Bilateral upper extremity activity training (VR)

10. Upper extremity reaction time training (VR) Virtual reality games will be played using the USE-IT intelligent physiotherapy game system. The system offers unilateral, bilateral and bimanual upper extremity training to individuals with a 55 inch touch screen and 7 computer games (balloon popping, car washing, plumbing, arithmetic, apartment, drum and matching).

Intervention Type: OTHER

Home-based Telerehabilitation

Strengthening, balance and coordination exercises will be sent to the participants via a mobile application. Patients will do the exercises at home and send a notification to their physiotherapist. Intervention will be applied for 1 hour, 3 days a week for 8 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosed with Relapsing Remitting, Primary Progressive or Secondary Progressive MS according to McDonald criteria,
• Between the age of 18 and 50 years
• EDSS score greater than 2, less than 5.5,
• Mini Mental State Test score of 24 and above,
• Volunteers who have access to smartphone (mobile phone) through themselves or their relatives will be included in the study.

Exclusion Criteria

• Surgery or botox application for spasticity in the last 6 months,
• Having an attack history in the last 3 months,
• Received physical therapy and rehabilitation services in the last 6 months,
• Any pain in any part of the body, previous surgery, any orthopedic problem,
• Have a secondary neurological, orthopedic or systematic condition that prevents standing independently,
• With severe peripheral vestibular involvement,
• EDSS- Pyramidal functions score equal to and greater than 4,
• Patients who do not agree to participate in the study and do not give written consent will not be included in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Mert Doğan

Physiotherapist in Neurological Rehabilitation Department, Master of Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mert Doğan

Ankara, Altındağ, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-53875521-050-713

Identifier Type: -

Identifier Source: org_study_id