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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02274935
Other study ID # 15002
Secondary ID
Status Completed
Phase N/A
First received October 22, 2014
Last updated October 25, 2016
Start date October 2014
Est. completion date September 2016

Study information

Verified date October 2016
Source University of Illinois at Urbana-Champaign
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study examines the effect of balance and walking exercise on cognition and mobility in people with Multiple Sclerosis.


Description:

Walking and cognitive impairments are common in persons with multiple sclerosis (MS). Approximately 85% of persons with MS report walking as a major limitation, whereas 65% experience cognitive dysfunction. Traditionally, walking and cognition have been viewed as unrelated, but there is evidence of cognitive-motor interference (CMI). CMI is believed to stem from damage to common neural tracts. Recent evidence supports cognitive-motor interference in persons with MS. For example, there is evidence that walking performance declines when performed in conjunction with a simultaneous cognitive task (i.e., dual task cost [DTC] of walking) and this decline in walking performance is greater in persons with MS compared to healthy controls. This elevated cognitive-motor interference during walking is mainly associated with walking performance in persons with MS although cognitive function does play a role. Cognitive-motor interference during mobility tasks is of practical and clinical importance because it has been linked to decreased community mobility and a greater risk of falls in other clinical populations. Despite the adverse consequences of elevated CMI there is ambiguity concerning prevention and rehabilitation strategies for cognitive-motor interference in individuals with MS.

This study seeks to examine whether single and/or targeted dual task rehabilitation has a beneficial effect on CMI in individuals with MS. The results of this investigation will provide the foundation for future rehabilitation-based randomized control trials seeking to improve walking and cognitive function in persons with MS.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:Physician diagnosed MS, relapse free for 30 days, self reporting problems with multitasking -

Exclusion Criteria:We will exclude all individuals with risk factors contra-indicative for undertaking strenuous exercise. Participants will verbally respond to a health history questionnaire. Those individuals who are asymptomatic and meet no more than one risk factor threshold including family history of coronary heart disease, cigarette smoking, hypertension, high cholesterol, diabetes, obesity, and sedentary lifestyle will be considered at low risk and included for participation.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Balance and gait exercise twice a week for an hour

Locations

Country Name City State
United States Motor control research lab Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive Motor interference This will be operationalized as the percent change in walking velocity from single (walking only) to dual task (walking while thinking). Participants will complete a total of 8 walking trials over a 20' pressure sensitive (Zeno™) walkway. Four at a comfortable walking speed and four as fast as possible. Half of the trials at each speed will be conducted while reciting every other letter of the alphabet (i.e. N, P, R, etc). 12 weeks No
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