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| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | December 12, 2007 | ||||
| Start Date ICMJE | November 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00177359 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Physical activity, endurance in walking, falls efficacy, performance of usual activities of living, pre and post intervention (12 weeks) | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Restoring Skill in Walking | ||||
| Official Title ICMJE | Restoring Skill in Walking | ||||
| 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). |
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| 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). |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Mobility Limitation | ||||
| Intervention ICMJE | Behavioral: gait intervention | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00177359 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 0508137 | ||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE | National Institute on Aging (NIA) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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