Clinical trial NCT04891341: Investigation of the Effects of Technology Supported Different Physiotherapy Approaches on Patients With Multiple Sclerosis
Official title: Investigation of the Effects of Technology Supported Different Physiotherapy Approaches on Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Virtual Reality
Telerehabilitation
Task-oriented Circuit Therapy
Kinematics
Kinematic Analysis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Change between baseline and after 8 weeks treatment.
measure: Multiple Sclerosis Quality of Life Scale (MSSQL-54)
timeFrame: Change between baseline and after 8 weeks treatment
Secondary outcomes:
measure: Trunk Impairment Scale
timeFrame: Change between baseline and after 8 weeks treatment.
measure: Timed Up and Go Test
timeFrame: Change between baseline and after 8 weeks treatment.
measure: Goal Assesment Scale
timeFrame: Change between baseline and after 8 weeks treatment.
measure: ABILHAND-Stroke
timeFrame: Change between baseline and after 8 weeks treatment.
measure: Minnesota Manual Dexterity Test
timeFrame: Change between baseline and after 8 weeks treatment.
measure: Twelve Item MS Walking Scale
timeFrame: Change between baseline and after 8 weeks treatment.
measure: Kinematic Analysis During Functional Activities
timeFrame: Change between baseline and after 8 weeks treatment.
measure: International Cooperative Ataxia Rating Scale
timeFrame: Change between baseline and after 8 weeks treatment.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Mert Doğan
state: Altındağ
Study officials:
References: