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Telerehabilitation-based Upper Extremity Training in People With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation-based Upper Extremity Training
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Physical Therapy and Rehabilitation, Dokuz Eylül UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Synchronized Telerehabilitation

Asynchronous Telerehabilitation

Arm Description

Physical activity training aiming to increase hand/arm function and fine motor function will be applied via videoconference for 8 weeks, 2 days a week, in 45-60 minute sessions.

Exercise videos and exercise tracking form will be sent.

Outcomes

Primary Outcome Measures

Nine-Hole Peg Test
The Nine-Hole Peg Test measures finger dexterity.

Secondary Outcome Measures

Expanded Disability Status Scale
Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Jamar Hand Dynamometer
The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.
Arm Function in Multiple Sclerosis Questionnaire
Arm Function in Multiple Sclerosis Questionnaire is a unidimensional 31-item questionnaire for measuring arm function in MS. The total sum score ranged from 31 to 186 and a high score indicates a low degree of arm function.
Preference-based Multiple Sclerosis Index
The Preference-based Multiple Sclerosis Index is a brief patient-reported outcome measure of health-related quality of life that consists of 5 items: walking, fatigue, mood, concentration, and roles and responsibilities. The scoring algorithm ranges from 0 (dead) to 1 (perfect health).
The Modified Fatigue Impact Scale - 5
The MFIS-5 measures the impact of fatigue on cognitive, physical and psychosocial function-considered by some authors to be three important sub-scales-in patients with MS. Each item is scored between 0 and 4, and a low score indicates a low degree of fatigue.
Sensewear Armband
The SenseWear Armband (SWA; Bodymedia, Pittsburgh, Pennsylvania, USA) is a lightweight metabolic monitor will be used to estimate energy expenditure.
Global Perceived Effect Scale
The global perceived effect (GPE) scale is a commonly used method for measuring patients' assessment of their condition. In different studies, different questions can be modified according to different levels and response styles. In our study, we will be asked the patient, "How do you find your hand/arm function compared to pre-rehabilitation?". They will be asked to choose one of the options "much improved, a little improved, no change, a little d e t e r i o r a t i o n, or much deterioration than before rehabilitation".
Impact of Participation and Autonomy Questionnaire
The IPAQ is a questionnaire that focuses on autonomy and participation of people with chronic conditions. The participation score ranges from 0-128, and experience of problems scores ranged from 0-16, with higher scores reflecting more restrictions in participation (less community participation) and/or more experience of problems.
Brief Pain Inventory-Short Form
The Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning on a 10 point scale. Higher scores reflecting more pain.

Full Information

First Posted
September 25, 2021
Last Updated
May 30, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05073731
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
October 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single (Outcomes Assessor)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Synchronized Telerehabilitation
Arm Type
Experimental
Arm Description
Physical activity training aiming to increase hand/arm function and fine motor function will be applied via videoconference for 8 weeks, 2 days a week, in 45-60 minute sessions.
Arm Title
Asynchronous Telerehabilitation
Arm Type
Active Comparator
Arm Description
Exercise videos and exercise tracking form will be sent.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation-based Upper Extremity Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nine-Hole Peg Test
Description
The Nine-Hole Peg Test measures finger dexterity.
Time Frame
Change from Baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Expanded Disability Status Scale
Description
Expanded Disability Status Scale is a method of quantifying disability in multiple sclerosis. The Expanded Disability Status Scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Time Frame
Baseline
Title
Jamar Hand Dynamometer
Description
The Jamar Hand Dynamometer will be used to measure isometric force and peak strength.
Time Frame
Change from Baseline at 8 weeks
Title
Arm Function in Multiple Sclerosis Questionnaire
Description
Arm Function in Multiple Sclerosis Questionnaire is a unidimensional 31-item questionnaire for measuring arm function in MS. The total sum score ranged from 31 to 186 and a high score indicates a low degree of arm function.
Time Frame
Change from Baseline at 8 weeks
Title
Preference-based Multiple Sclerosis Index
Description
The Preference-based Multiple Sclerosis Index is a brief patient-reported outcome measure of health-related quality of life that consists of 5 items: walking, fatigue, mood, concentration, and roles and responsibilities. The scoring algorithm ranges from 0 (dead) to 1 (perfect health).
Time Frame
Change from Baseline at 8 weeks
Title
The Modified Fatigue Impact Scale - 5
Description
The MFIS-5 measures the impact of fatigue on cognitive, physical and psychosocial function-considered by some authors to be three important sub-scales-in patients with MS. Each item is scored between 0 and 4, and a low score indicates a low degree of fatigue.
Time Frame
Change from Baseline at 8 weeks
Title
Sensewear Armband
Description
The SenseWear Armband (SWA; Bodymedia, Pittsburgh, Pennsylvania, USA) is a lightweight metabolic monitor will be used to estimate energy expenditure.
Time Frame
Change from Baseline at 8 weeks
Title
Global Perceived Effect Scale
Description
The global perceived effect (GPE) scale is a commonly used method for measuring patients' assessment of their condition. In different studies, different questions can be modified according to different levels and response styles. In our study, we will be asked the patient, "How do you find your hand/arm function compared to pre-rehabilitation?". They will be asked to choose one of the options "much improved, a little improved, no change, a little d e t e r i o r a t i o n, or much deterioration than before rehabilitation".
Time Frame
At 8 weeks
Title
Impact of Participation and Autonomy Questionnaire
Description
The IPAQ is a questionnaire that focuses on autonomy and participation of people with chronic conditions. The participation score ranges from 0-128, and experience of problems scores ranged from 0-16, with higher scores reflecting more restrictions in participation (less community participation) and/or more experience of problems.
Time Frame
Change from Baseline at 8 weeks
Title
Brief Pain Inventory-Short Form
Description
The Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning on a 10 point scale. Higher scores reflecting more pain.
Time Frame
Change from Baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Turhan Kahraman, PhD
Phone
+905557219849
Email
turhan.kahraman@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serkan Ozakbas, MD
Organizational Affiliation
MS Outpatient Clinic, Dokuz Eylul University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
School of Physical Therapy and Rehabilitation, Dokuz Eylül University
City
Izmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozge Ertekin, Assoc Prof, PhD
Phone
+90 2324124941
Email
ozge28altin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Seda Dastan, BSc
First Name & Middle Initial & Last Name & Degree
Turhan Kahraman, Assoc Prof, PhD
First Name & Middle Initial & Last Name & Degree
Asiye Tuba Ozdogar, MSc
First Name & Middle Initial & Last Name & Degree
Serkan Ozakbas, Prof, MD
First Name & Middle Initial & Last Name & Degree
Cavid Baba, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Telerehabilitation-based Upper Extremity Training in People With Multiple Sclerosis

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