Telerehabilitation vs Supervised Exercises in MS

NCT ID: NCT04413682

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-05-30

Brief Summary

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Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a safe and effective rehabilitation tool for PwMS. A structured and personalized exercise program can improve physical fitness, functional capacity, quality of life and modifiable disorders in PwMS. On the other hand, Telerehabilitation is an alternative rehabilitation method in PwMS. The purpose of this study is to investigate the effectiveness of exercise programs and telerehabilitation on ADL and QoL in PwMS, and compare the effects of supervised exercise and home-based exercise programs for the PwMS.

Detailed Description

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Participants are randomly assigned to the structured supervised exercise or structured home-based groups. Interventions in Group 1 (n=15) includes one session per day, 3 days a week over a 12-weeks structured exercise program under the supervision of a physical therapist. Group 2 (n=15) includes a 12-week structured home-based exercise program checked and controlled through telerehabilitation three times a week. All measurements pre-post intervention.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will randomly assign to the structured supervised exercise or structured home-based groups. Randomization are done using Microsoft Excel 'RAND()' function.

Study Groups

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Supervised Exercise Group

One session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist.

Group Type EXPERIMENTAL

Structured Supervised Exercise

Intervention Type BEHAVIORAL

Structured Exercise Program under the supervision of Physical Therapist

Telerehabilitation Group

One session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation

Group Type EXPERIMENTAL

Structured telerehabilitation

Intervention Type BEHAVIORAL

Structured Exercise Program checked and controlled through telerehabilitation

Interventions

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Structured Supervised Exercise

Structured Exercise Program under the supervision of Physical Therapist

Intervention Type BEHAVIORAL

Structured telerehabilitation

Structured Exercise Program checked and controlled through telerehabilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

patients with:

1. Stable period at the time of application to the clinic
2. Expanded Disability Status Scale Levels between 2 - 6.5
3. Appropriate cognitive level to understand the exercises
4. No diseases to affect their participation in exercise programs

Exclusion Criteria

patients with:

1. Poorly controlled diabetes, hypertension or other medical conditions to be incompatible with study participation,
2. A new history of previous attacks
3. No reliable informed consent
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

Medipol University

OTHER

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Ela Tarakci

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ela Tarakci, Professor

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Istanbul University-Cerrahpaşa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MS-TeleRehab2019

Identifier Type: -

Identifier Source: org_study_id

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