Asymmetric Locomotor Training in the Elderly to Restore Physical Function

Disability Clinical Trial

Official title:

Asymmetric Locomotor Training in the Elderly to Restore Physical Function

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01537341
• Other study ID #: UF_IOA_Pepper_Nocera
• Status: Withdrawn
• Phase: N/A
• First received: February 14, 2012
• Last updated: July 18, 2013
• Start date: April 2012
• Est. completion date: April 2012

Study information

• Verified date: July 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 89 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disability

Intervention

Behavioral:
• Traditional Treadmill
Participants will complete the intervention in 12-weeks, 3 times per week sessions.
• Split-belt
Participants will complete the intervention in 12-weeks, 3 times per week sessions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gait speed, as measure by 400 meter walk time, following 12-weeks of 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	No
Secondary	Change in gait variability from pre to post 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	No