Restoring Skill in Walking
Primary Purpose
Mobility Limitation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gait intervention
Sponsored by
About this trial
This is an interventional treatment trial for Mobility Limitation focused on measuring gait impairment
Eligibility Criteria
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%)
Sites / Locations
- University of Pittsburgh
Outcomes
Primary Outcome Measures
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 Outcome Measures
Physical activity, endurance in walking, falls efficacy, performance of usual activities of living, pre and post intervention (12 weeks)
Full Information
NCT ID
NCT00177359
First Posted
September 12, 2005
Last Updated
December 12, 2007
Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT00177359
Brief Title
Restoring Skill in Walking
Official Title
Restoring Skill in Walking
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation
Keywords
gait impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
gait intervention
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Physical activity, endurance in walking, falls efficacy, performance of usual activities of living, pre and post intervention (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessie VanSwearingen, PhD, PT
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22003158
Citation
VanSwearingen JM, Perera S, Brach JS, Wert D, Studenski SA. Impact of exercise to improve gait efficiency on activity and participation in older adults with mobility limitations: a randomized controlled trial. Phys Ther. 2011 Dec;91(12):1740-51. doi: 10.2522/ptj.20100391. Epub 2011 Oct 14.
Results Reference
derived
Learn more about this trial
Restoring Skill in Walking
We'll reach out to this number within 24 hrs