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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03497468
Other study ID # kunal
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 3, 2018
Last updated April 12, 2018
Start date April 2018
Est. completion date June 2018

Study information

Verified date April 2018
Source Bezmialem Vakif University
Contact Kamer Unal-Eren, PT, PhD
Phone +902125232288
Email kamerunals@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date June 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Combined exercise training
Aerobic training with cycle ergometer %60-80 of maximal Heart Rate, submaximal level, strengthening of the major muscles of upper and lower extremities
Task-oriented training
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Outcome

Type Measure Description Time frame Safety issue
Primary Functional capacity Change from baseline functional capacity with six minute walking test 6 weeks
Secondary dynamic gait skills Change from baseline functional mobility with dynamic gait index 6 weeks
Secondary limitation of gait Change from baseline functional mobility with MS walking scale-12 6 weeks
Secondary dynamic balance and fall risk Change from baseline functional mobility with timed up and go test 6 weeks
Secondary sitatic balance Change from baseline balance with functional reach test 6 weeks
Secondary dynamic balance Change from baseline balance with berg balance scale 6 weeks
Secondary severity of fatigue Change from baseline fatigue with fatigue severity scale 6 weeks
Secondary impact of fatigue Change from baseline fatigue with fatigue impact scale 6 weeks
Secondary Quality of life Change from baseline quality of life with MS quality of life instrument-54 6 weeks
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