- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02274935
Cognitive Motor Interference Rehabilitation in Persons With Multiple Sclerosis (DUETS)
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Urbana, Illinois, United States, 61801
- Motor control research lab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Gait and balance exercise
Traditional exercises focusing on gait and balance
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Balance and gait exercise twice a week for an hour
Other Names:
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Experimental: Cognitive training and physical exercise
Gait and balance exercises done in combination with cognitive training (i.e.
counting backwards by 7s from 98)
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Balance and gait exercise twice a week for an hour
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cognitive Motor interference
Time Frame: 12 weeks
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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).
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12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Jacob Sosnoff, PhD, Associate Professor, University of Illinois
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15002 (Other Identifier: City of Hope Medical Center)
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.
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