Restoring Central Motor Control Extension

Gait, Unsteady Clinical Trial

— PRIMA-NIRS  

Official title:

Restoring Central Motor Control to Improve Community Mobility of Older Adults

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04302831
• Other study ID #: STUDY19110142
• Secondary ID: R01AG057671-01A1
• Status: Withdrawn
• Phase: N/A
• Start date: March 4, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Unsteady

Intervention

Behavioral:
• Strength training
weight lifting to increase muscle strength
• Endurance training
treadmill walking to increase endurance
• Flexibility training
stretches to improve flexibility
• Physical activity behavioral intervention
Intervention to encourage participants to be more physically active
• Task Specific timing and coordination training
stepping and walking patterns to improve timing and coordination of gait

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
Other	Activity Space	Extent of travel beyond the home collected by GPS device based on a standard deviation ellipse of spatial measurement points.	12, 24, and 36 weeks
Primary	Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking	Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).	change from baseline to 12 weeks
Primary	Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking	Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).	change from baseline to 36 weeks
Secondary	Gait speed	Walking speed (m/s) during usual pace	12, 24, and 36 weeks
Secondary	Gait speed	Walking speed (m/s) with a cognitive challenge.	12, 24, and 36 weeks
Secondary	Gait speed	Walking speed (m/s) on an uneven surface.	12, 24, and 36 weeks
Secondary	Gait variability	Fluctuations in gait characteristics from step to step during usual pace. Physiologic measure of temporal gait characteristics (standard deviation).	12, 24, and 36 weeks
Secondary	Gait variability	Fluctuations in gait characteristics from step to step while walking with a cognitive challenge. Physiologic measure of temporal gait characteristics (standard deviation).	12, 24, and 36 weeks
Secondary	Gait variability	Fluctuations in gait characteristics from step to step while walking on an uneven surface. Physiologic measure of temporal gait characteristics (standard deviation).	12, 24, and 36 weeks