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

NCT04891341 | Completed

• 1 other identifier: E-53875521-050-713
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Virtual Reality; Telerehabilitation; Task-oriented Circuit Therapy; Kinematics; Kinematic Analysis

Outcome Measures

Primary Outcomes (2)

• Berg Balance Scale

  Berg Balance Scale will be used to determine the balance exposure level of the volunteers. It is a scale that includes the performance of 14 different tasks between 0 (not applicable) and 4 (normal performance). In this scale, which is evaluated over 56 points; Scores between 0 and 20 indicate imbalance, scores between 21 and 40 indicate that the balance is acceptable, and scores between 41 and 56 indicate that the balance is good.

  Change between baseline and after 8 weeks treatment.

• Multiple Sclerosis Quality of Life Scale (MSSQL-54)

  Individuals' quality of life will be evaluated with MSQOL-54. In this scale consisting of 12 chapters and 54 questions in total, physical function, social function, physical role limitations, emotional role limitations, cognitive function, pain, emotional state, energy, sexual function, health perception, general quality of life, health stress and emotional well-being.

  Change between baseline and after 8 weeks treatment

Secondary Outcomes (8)

• Trunk Impairment Scale

  Change between baseline and after 8 weeks treatment.

• Timed Up and Go Test

  Change between baseline and after 8 weeks treatment.

• Goal Assesment Scale

  Change between baseline and after 8 weeks treatment.

• ABILHAND-Stroke

  Change between baseline and after 8 weeks treatment.

• Minnesota Manual Dexterity Test

  Change between baseline and after 8 weeks treatment.

Study Arms (2)

Technology Supported Task-Oriented Circuit Therapy Group

EXPERIMENTAL

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.

Other: Technology Supported Task-Oriented Circuit Training

Home-based Telerehabilitation Group

ACTIVE COMPARATOR

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.

Other: Home-based Telerehabilitation

Interventions

Technology Supported Task-Oriented Circuit Training 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).

Technology Supported Task-Oriented Circuit Therapy Group

Home-based Telerehabilitation 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.

Home-based Telerehabilitation Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Mert Doğan

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist in Neurological Rehabilitation Department, Master of Science

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 18, 2021
• Study Start: February 16, 2021
• Primary Completion: July 16, 2022
• Study Completion: July 17, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

TU (1)