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Telerehabilitation in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
Video exercise
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of multiple scleroisis

Exclusion Criteria:

  • Any musculoskeletal condition preventing patients to actively participate in exercise sessions

Sites / Locations

  • Marmara University School of Medicine Department of Physical Medicine and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation

Video exercise

Arm Description

Outcomes

Primary Outcome Measures

Pittsburgh Sleep Quality Scale

Secondary Outcome Measures

Full Information

First Posted
July 27, 2021
Last Updated
July 27, 2021
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04979845
Brief Title
Telerehabilitation in Multiple Sclerosis
Official Title
The Effect on Telerehabilitation on Fatigue and Sleep Quality in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara 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
Patients with multiple sclerosis will be randomized into two groups. One group will receive live telerehabilitation sessions 3 times a week over a course of three months. The other group will receive video instructions for aerobic and strengthening exercises. Patients fatigue, sleep quality and quality of life will be measured.

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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Title
Video exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
Patients will receive telerehabilitation sessions for 12 weeks including aerobic and strengthening exercises
Intervention Type
Other
Intervention Name(s)
Video exercise
Intervention Description
Patients will receive video instructions for home based exercises
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Scale
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of multiple scleroisis Exclusion Criteria: Any musculoskeletal condition preventing patients to actively participate in exercise sessions
Facility Information:
Facility Name
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozge Kenis-Coskun, MD
Phone
5058294947
Email
ozgekenis@gmail.com
First Name & Middle Initial & Last Name & Degree
MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Telerehabilitation in Multiple Sclerosis

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