Restoring Central Motor Control Extension

Not Applicable

Withdrawn

• Conditions: Gait, Unsteady

• Registration Number: NCT04302831
• Lead Sponsor: University of Pittsburgh

Brief Summary

Motor skill training therapy aims to improve the brain's control of walking and can improve clinic-based measures of walking in older adults. However, it is unknown whether the benefits of motor skill training extend to real world mobility measures. The investigators will test the effects of motor skill training on measures of community mobility of older adults and assess the mechanisms through improved motor control at the level of the brain. These results will inform intervention approaches to maintain community mobility of older adults and prevent disability and institutionalization.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-26
• Study Start: 2020-03-04
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 65 years of age and older
• Ambulatory without an assistive device or the assistance of another person
• Usual 4 meter gait speed > 0.60 m/s and < 1.2 m/s
• Physician clearance to participate in a moderate intensity exercise program
• Not meeting physical activity recommendations defined as reporting less than 150 minutes of moderate intensity activity per week in the past month.

Exclusion Criteria

• persistent lower extremity pain that is present on most days of the week
• back pain that is present on most days of the weeks and interferes with walking and - activities of daily living or back pain that increases with walking
• refuse to walk on a treadmill
• plans to move out of the area in the next 5 years
• dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD)
• any acute illness or medical condition that is not stable according to the approving physician
• resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate > 100 or < 40 beats per minute
• diagnosed dementia or cognitive impairment defined as modified Mini-Mental State (3MS) examination <79
• hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures
• severe visual impairment f- ixed or fused lower extremity joints such as hip, knee or ankle
• lower extremity strength <3/5 on manual muscle testing
• lower extremity amputation
• progressive movement disorder such as Multiple Sclerosis, Amyotrophic Lateral Sclerosis or Parkinson's disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking	change from baseline to 36 weeks	Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).

Secondary Outcome Measures

Name	Time	Method
Gait speed	12, 24, and 36 weeks	Walking speed (m/s) on an uneven surface.
Gait variability	12, 24, and 36 weeks	Fluctuations in gait characteristics from step to step while walking on an uneven surface. Physiologic measure of temporal gait characteristics (standard deviation).

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States