Asymmetric Locomotor Training in the Elderly to Restore Physical Function

NCT01537341 | Withdrawn

• 1 other identifier: UF_IOA_Pepper_Nocera
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Disability

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in gait variability from pre to post 12-week intervention

  Participants will be evaluated within 1-week prior to begining the intervention and within 1-week following completion of the 12-week intervention

Study Arms (2)

Traditional Treadmill

ACTIVE COMPARATOR

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

Split-belt

EXPERIMENTAL

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

Interventions

Traditional Treadmill BEHAVIORAL

Participants will complete the intervention in 12-weeks, 3 times per week sessions.

Also known as: Traditional Treadmill is a single belt/speed treadmill.

Traditional Treadmill

Split-belt BEHAVIORAL

Participants will complete the intervention in 12-weeks, 3 times per week sessions.

Also known as: Split-belt has two seprate belts.

Split-belt

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Officials

• Chris Hass, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 23, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 19, 2013

Record last verified: 2013-07