- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01537341
Asymmetric Locomotor Training in the Elderly to Restore Physical Function
July 18, 2013 updated by: University of Florida
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 89 years (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Participants will complete the intervention in 12-weeks, 3 times per week sessions.
Other Names:
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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.
|
Participants will complete the intervention in 12-weeks, 3 times per week sessions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
Participants will be evaluated within 1-week prior to begining the intervention and within 1-week following completion of the 12-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
Participants will be evaluated within 1-week prior to begining the intervention and within 1-week following completion of the 12-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chris Hass, Ph.D., University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (ACTUAL)
April 1, 2012
Study Completion (ACTUAL)
April 1, 2012
Study Registration Dates
First Submitted
February 14, 2012
First Submitted That Met QC Criteria
February 22, 2012
First Posted (ESTIMATE)
February 23, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
July 19, 2013
Last Update Submitted That Met QC Criteria
July 18, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- UF_IOA_Pepper_Nocera
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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