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Clinical Trials/NCT02554916
NCT02554916
Completed
Not Applicable

Effectiveness of Rehabilitation Interventions for Mobility Impairment in Parkinson's Disease

University of Florida1 site in 1 country58 target enrollmentJuly 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Age-related Mobility Decline
Sponsor
University of Florida
Enrollment
58
Locations
1
Primary Endpoint
Change in temporal variability
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This is an exploratory study designed to investigate the effects of aerobic dual belt treadmill walking versus traditional treadmill exercise on gait performance and functional capacity in older adults at risk for mobility disability. Identifying the relationship between aerobic treadmill exercise (dual belt or traditional) and the recovery of walking abilities will serve to optimize current rehabilitation approaches.

Detailed Description

Participants will be forty-eight older adults with pre-clinical mobility disability who will be randomized into one of three intervention groups: dual-belt treadmill exercise, traditional treadmill exercise, or non-contact control. Prior to and following 16 weeks of therapy, we will observe the participants' performing several functional movements (walking, standing from sitting, sitting from standing, walking up and down stairs) and measure their muscular activity. These performance-based measures will be obtained to determine whether their movement function improves as a result of therapeutic intervention. The participants' absolute performance on any of these tasks does not matter as much as that they make the very best effort on each of the tests. They are welcome to take a break at any point in the testing or training.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
July 17, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 65 and older
  • Gait Speed of ≤ 1m/s
  • Summary score 7-10 on the Short Physical Performance Battery, indicating mild to moderate impairment
  • Sedentary as defined by reporting \<20 min/wk of performing regular physical activity in the past month and \<125 min/wk of moderate physical activity on the CHAMPS-18 questionnaire
  • Willingness to be randomized to any of the treatment groups

Exclusion Criteria

  • Failure to provide informed consent
  • Planned surgery in next year
  • Hospitalization within the past 6 months
  • Smoker \> 1 pack per day
  • Significant cognitive impairment, defined as a known diagnosis of dementia or a Modified Mini-Mental State score \<24
  • Significant cognitive executive impairment, defined as a Montreal Cognitive Assessment (MoCA) score of\<25
  • Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis, Amyotrophic lateral sclerosis (ALS)
  • Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease
  • Terminal illness with life expectancy less than 12 mos, as determined by a physician
  • Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen

Outcomes

Primary Outcomes

Change in temporal variability

Time Frame: baseline and up to 6 weeks following the intervention

Temporal will be determined from kinematic and kinetic measurement methods. Lower values correspond to better walking performance.

Change in Gait Speed

Time Frame: baseline and up to 6 weeks following the intervention

Gait speed will be determined from kinematic and kinetic measurement methods. A low value would indicate a slower walking speed compared to a higher value (faster walking speed).

Change in spatial variability

Time Frame: baseline and up to 6 weeks following the intervention

Spatial will be determined from kinematic and kinetic measurement methods. Lower values correspond to better walking performance.

Secondary Outcomes

  • Change in Disability(baseline and up to 6 weeks following the intervention)
  • Change in Timed up and Go(baseline and up to 6 weeks following the intervention)
  • Change in physical performance(baseline and up to 6 weeks following the intervention)
  • Change in cognitive impairment(baseline and up to 6 weeks following the intervention)
  • Change in Cognitive impairment of executive function(baseline and up to 6 weeks following the intervention)
  • Change in likelihood of falling(baseline and up to 6 weeks following the intervention)
  • Change in knee extensor strength(baseline and up to 6 weeks following the intervention)
  • Change in ankle plantarflexor strength(baseline and up to 6 weeks following the intervention)
  • Change in timed chair rise(baseline and up to 6 weeks following the intervention)
  • Change in timed stair climb(baseline and up to 6 weeks following the intervention)
  • Change in Ambulatory activity(baseline and up to 6 weeks following the intervention)
  • Change in energetic cost of walking(baseline and up to 6 weeks following the intervention)

Study Sites (1)

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