Restoring Skill in Walking

Mobility Limitation Clinical Trial

Official title:

Restoring Skill in Walking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177359
• Other study ID #: 0508137
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: December 12, 2007
• Start date: November 2005
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to examine the effect of an intervention to improve walking based on motor learning (skill-based) compared to the usual intervention (strength, flexibility and balance-based) on clinical, psychological and laboratory measures of walking and balance of older adults with mobility disability (walking problems).

Description:

While therapeutic exercise to improve mobility and balance appears to improve physical performance and may reduce falls, less is known about the responsiveness to specific interventions or the relation between response to intervention and the underlying problems or impairments. Therapeutic approaches for improving mobility and reducing fall risk are heterogeneous, but do not consistently focus on problem solving as a method of enhancing motor control or skill, an approach that has been found to be important for motor learning in animal models.

This two-year pilot study will allows us to compare the clinical, psychological and laboratory outcomes after a motor-learning based and an impairment-targeted exercise intervention to improve walking in older adults. All subjects will participate in pre and post intervention testing and a 12 week exercise intervention for gait involving either a motor learning (skill enhancement) or impairment-targeted (lower extremity strengthening, flexibility and gait cues).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65 years of age and older

• Ambulatory (with or without a straight cane, and without the assistance of another person)

• Have written approval/clearance of their physician to participate in low to moderate intensity, supervised exercise as is characteristic of the interventions for improving gait.

• Difficulty with walking or balance as indicated by the following two criteria during baseline testing:

• mild to moderate slowing of walking speed (walking speed = .6m/s and = 1.0m/s) and,

• gait variability (step length coefficient of variability, CV > 4.5%, or step width CV < 7% or > 30%)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mobility Limitation

Intervention

Behavioral:
• gait intervention

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gait variability, energy cost of walking, perception of effort in walking, and adaptability of gait to changing environmental conditions, pre and post intervention (12 weeks)
Secondary	Physical activity, endurance in walking, falls efficacy, performance of usual activities of living, pre and post intervention (12 weeks)