Effects of Task-oriented Training on Functional Mobility and Fatigue in Patients With Multiple Sclerosis
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Kamer Unal-Eren, PT, PhD
- Phone Number: 4650 +902125232288
- Email: kamerunals@yahoo.com
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
Other Study ID Numbers
- kunal
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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