Clinical trial NCT05073731: Telerehabilitation-based Upper Extremity Training in People With Multiple Sclerosis
Official title: Investigation of the Effects of the Synchronized Telerehabilitation-based Upper Extremity Training Program on Hand-arm Function, Pain, Fatigue, Quality of Life, and Participation in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: In this studly, the effects of an 8-week telerehabilitation-based upper extremity training in persons with multiple sclerosis will be investigated.

Detailed description: Multiple sclerosis is a chronic, progressive, and demyelinating disease of the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults. The most common clinical signs and symptoms include motor dysfunction, fatigue, spasticity, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction.

66% of people with MS have impaired upper extremity function. As a result of the deterioration in upper extremity function, the performance of many daily living activities affects performance. In conclusion, there is a decrease in the functional independence of individuals, quality of life, and participation in activities in the community.

Telerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies." Synchronized telerehabilitation provides the participant with advantages such as customized treatment, instant feedback, and a social environment such as face-to-face training. Telerehabilitation has proven to be a valuable modality for people with MS by increasing physical activity and reducing fatigue.

In terms of telerehabilitation-based upper extremity exercise training results, the MS population is deficient. Considering the importance of bilateral hand/arm function in daily life, this deficiency in the telerehabilitation-based training effect is eliminated.

For this reason, the results of this study, which will be created for the development of upper extremity telerehabilitation strategies in MS patients, will aim to improve the hand/arm function and fine motor skills of people with MS, aiming to increase the quality of life of individuals and to participate more actively in society.

Persons who followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. A total of 30 participants will randomly be divided into 2 groups as synchronized telerehabilitation group and asynchronous telerehabilitation group.

A physiotherapist will give physical activity training aiming to increase hand/arm function and fine motor function to the Synchronized Telerehabilitation Treatment Group via videoconference for eight weeks, two days a week, in 45-60 minute sessions. Exercise videos and exercise tracking forms will be sent to the Asynchronous Telerehabilitation Treatment Group, the control group, with the exercise intensity and intensity equalized and their progression every two weeks. Assessments will done at baseline, after 8 weeks (post-treatment) and at 8 weeks (follow-up). Assessments will be done by assessors who are blinded to the group allocation.

Eligibility criteria: Inclusion Criteria:

* Having a definitive diagnosis of MS according to the 2017 McDonald criteria
* Being over 18 years old
* Having answered yes to the question "Do you experience restriction in your hand-arm function and fine motor skills while performing your functional activities in daily life, and does this restriction limit your activities?"
* To have sufficient computer knowledge or to have a relative who can help in this regard to participate in the study for people with MS in the telerehabilitation group
* Having a computer and active internet connection at home for individuals with MS in the telerehabilitation group
* To be willing to participate in the study.

Exclusion Criteria:

* Having a neurological disease other than MS
* Having a relapse 30 days before or during the study
* Having an orthopedic problem that may affect the function of the upper extremity
* Cognitive disability at a level that hinders assessment and treatment.

Primary outcomes:
measure: Nine-Hole Peg Test
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Expanded Disability Status Scale
timeFrame: Baseline
measure: Jamar Hand Dynamometer
timeFrame: Change from Baseline at 8 weeks
measure: Arm Function in Multiple Sclerosis Questionnaire
timeFrame: Change from Baseline at 8 weeks
measure: Preference-based Multiple Sclerosis Index
timeFrame: Change from Baseline at 8 weeks
measure: The Modified Fatigue Impact Scale - 5
timeFrame: Change from Baseline at 8 weeks
measure: Sensewear Armband
timeFrame: Change from Baseline at 8 weeks
measure: Global Perceived Effect Scale
timeFrame: At 8 weeks
measure: Impact of Participation and Autonomy Questionnaire
timeFrame: Change from Baseline at 8 weeks
measure: Brief Pain Inventory-Short Form
timeFrame: Change from Baseline at 8 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: School of Physical Therapy and Rehabilitation, Dokuz Eylül University
Study officials:
affiliation: MS Outpatient Clinic, Dokuz Eylul University Hospital
name: Serkan Ozakbas, MD
role: STUDY_DIRECTOR
References: