Asymmetric Locomotor Training in the Elderly to Restore Physical Function

This study has been withdrawn prior to enrollment.
(Funding was not received for this study.)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01537341
First received: February 14, 2012
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Disability
Behavioral: Traditional Treadmill
Behavioral: Split-belt

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Asymmetric Locomotor Training in the Elderly to Restore Physical Function

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in gait speed, as measure by 400 meter walk time, following 12-weeks of intervention [ Time Frame: Participants will be evaluated within 1-week prior to begining the intervention and within 1-week following completion of the 12-week intervention ] [ Designated as safety issue: No ]
    Participants will be asked to walk at their usual pace, without over exerting. They can stop for up to 1 min for fatigue or other symptoms. A time limit of 15 minutes to perform the test has been established based on the following considerations.


Secondary Outcome Measures:
  • Change in gait variability from pre to post 12-week intervention [ Time Frame: Participants will be evaluated within 1-week prior to begining the intervention and within 1-week following completion of the 12-week intervention ] [ Designated as safety issue: No ]
    We will test this working hypothesis by examining changes in spatial and temporal characteristics of gait that occur following 12-weeks of split-belt versus traditional treadmill training. Measures of interest will include variability in stance time, step length, stride length, stride time, swing time, and double limb support time directly from the GAITRite.


Enrollment: 0
Study Start Date: April 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional Treadmill
Participants will follow the same guidelines as the split belt component but will complete the intervention on a traditional, single belt/speed treadmill.
Behavioral: Traditional Treadmill
Participants will complete the intervention in 12-weeks, 3 times per week sessions.
Other Name: Traditional Treadmill is a single belt/speed treadmill.
Experimental: Split-belt
Participants will walk on a custom-built split-belt treadmill comprised of two separate belts, each with its own motor, that permitted the speed of each belt (i.e. each leg) to be controlled independently.
Behavioral: Split-belt
Participants will complete the intervention in 12-weeks, 3 times per week sessions.
Other Name: Split-belt has two seprate belts.

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

Ages Eligible for Study:   65 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01537341

Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Chris Hass, Ph.D. University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01537341     History of Changes
Other Study ID Numbers: UF_IOA_Pepper_Nocera
Study First Received: February 14, 2012
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014