- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03497468
Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis
June 30, 2026 updated by: Kamer Unal, Bezmialem Vakif University
Multiple Sclerosis (MS) is inflammatory, demyelinating and autoimmune disease of the central nervous system.
It is usually seen with relapses and genetic and environmental factors play a role in the etiology.
Neurological symptoms seen in MS restrict the patient's daily activity and social role participation.
Mobility problems and fatigue are the most important reasons of role limitations and decreased quality of life.
The importance of exercise training in disease management has been emphasized in recent years.
However, few studies have investigated the effects of task-oriented trainings on symptoms of the disease.
The aim of this sudy is to investigate the effects of task-oriented training additional to combined exercise training on functional capacity, mobility, balance, fatigue and quality of life in patients with MS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Multiple Sclerosis diagnosis
- Expanded Disability Status Scale > 5,5
- No cognitive problems
- No relapses in the last 3 months
- No other neurological or chronic disease
Exclusion Criteria:
- Relapse during the intervention
- Exercise intolerance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
Patients in this group will receive combined exercise training included aerobic and strengthening exercises, 3 times a week for 6 weeks.
All exercise sessions will be performed under the supervision of a physiotherapist.
|
Aerobic training with cycle ergometer %60-80 of maximal Heart Rate, submaximal level, strengthening of the major muscles of upper and lower extremities
|
|
Experimental: Training group
Patients in this group will receive task-oriented training additional to combined exercise training 3 times a week for 6 weeks.
Task-oriented training included more functional daily life mobility activities like reaching, obstacle walking, stairs climbing.
All exercise sessions will be performed under the supervision of a physiotherapist.
|
Functional reaching, walking on different obstacles and floor,sitting and standing on different levels and surface,walking around obstacle, climbing stairs with different height and surface
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional capacity
Time Frame: 6 weeks
|
Change from baseline functional capacity with six minute walking test
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
dynamic gait skills
Time Frame: 6 weeks
|
Change from baseline functional mobility with dynamic gait index
|
6 weeks
|
|
limitation of gait
Time Frame: 6 weeks
|
Change from baseline functional mobility with MS walking scale-12
|
6 weeks
|
|
dynamic balance and fall risk
Time Frame: 6 weeks
|
Change from baseline functional mobility with timed up and go test
|
6 weeks
|
|
sitatic balance
Time Frame: 6 weeks
|
Change from baseline balance with functional reach test
|
6 weeks
|
|
dynamic balance
Time Frame: 6 weeks
|
Change from baseline balance with berg balance scale
|
6 weeks
|
|
severity of fatigue
Time Frame: 6 weeks
|
Change from baseline fatigue with fatigue severity scale
|
6 weeks
|
|
impact of fatigue
Time Frame: 6 weeks
|
Change from baseline fatigue with fatigue impact scale
|
6 weeks
|
|
Quality of life
Time Frame: 6 weeks
|
Change from baseline quality of life with MS quality of life instrument-54
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
April 3, 2018
First Submitted That Met QC Criteria
April 12, 2018
First Posted (Actual)
April 13, 2018
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 30, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Multiple Sclerosis
- Fatigue
- Multiple Sclerosis, Relapsing-Remitting
Other Study ID Numbers
- kunal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.