Clinical trial NCT01537341: Asymmetric Locomotor Training in the Elderly to Restore Physical Function
Official title: Asymmetric Locomotor Training in the Elderly to Restore Physical Function
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Disability
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Innovative advances in rehabilitation technology have created a split-belt treadmill capable of providing a much needed intervention aimed at limiting mobility disability. When desynchronized, the split-belt treadmill imposes demands on each leg such that the central nervous system must adapt to the challenge. Based on preliminary data from our lab utilizing the split-belt treadmill, the investigators hypothesize this intervention can challenge the locomotor processes required for safe, efficient gait while concurrently providing an aerobic stimulus will produce favorable changes in physical function in older adults at risk for mobility disability.

Detailed description: For this pilot study the investigators will enroll 20 sedentary older adults at risk for disability (usual gait speed ≤ 1.0 m/s). Participants will be assigned to one of two 12-week interventions. Therefore the final training pool will consist of 10 split-belt participants and 10 traditional treadmill participants. Aim 1 will test the hypothesis that compared with a traditional treadmill intervention a split-belt treadmill intervention will result in improved mobility, as measure by 400 meter walk time, as well self reported physical function/disability as measured by the Pepper Assessment Tool for Disability. Aim 2 will test the hypothesis that compared with a traditional treadmill intervention a split-belt treadmill intervention will results in improved gait variability. To date, no experimental study has evaluated these propositions in a controlled trial testing the effects of split-belt training in older adults at risk for disability.

Eligibility criteria: Inclusion Criteria:

* aged 65 to 89
* walking speed of ≤ 1 m/s
* ≥ 0.033s of stance time variability
* sedentary as defined by spending less than 20 minutes per week in the past month getting regular physical activity

Exclusion Criteria:

* Significant cognitive impairment
* Failure to provide informed consent
* The need of a walker during the 400 meter walk
* Progressive, degenerative neurological disease
* Severe diabetes, requiring use of insulin

Primary outcomes:
measure: Change in gait speed, as measure by 400 meter walk time, following 12-weeks of intervention
timeFrame: Participants will be evaluated within 1-week prior to begining the intervention and within 1-week following completion of the 12-week intervention
Secondary outcomes:
measure: Change in gait variability from pre to post 12-week intervention
timeFrame: Participants will be evaluated within 1-week prior to begining the intervention and within 1-week following completion of the 12-week intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Chris Hass, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: