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Restoring Central Motor Control Extension

Restoring Central Motor Control to Improve Community Mobility of Older Adults

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04302831
Acronym
PRIMA-NIRS
Enrollment
0
Registered
2020-03-10
Start date
2020-03-04
Completion date
2020-12-01
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait, Unsteady

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.

Interventions

BEHAVIORALStrength training

weight lifting to increase muscle strength

BEHAVIORALEndurance training

treadmill walking to increase endurance

stretches to improve flexibility

Intervention to encourage participants to be more physically active

stepping and walking patterns to improve timing and coordination of gait

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walkingchange from baseline to 12 weeksPhysiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).

Secondary

MeasureTime frameDescription
Gait speed12, 24, and 36 weeksWalking speed (m/s) during usual pace
Gait variability12, 24, and 36 weeksFluctuations in gait characteristics from step to step during usual pace. Physiologic measure of temporal gait characteristics (standard deviation).

Other

MeasureTime frameDescription
Activity Space12, 24, and 36 weeksExtent of travel beyond the home collected by GPS device based on a standard deviation ellipse of spatial measurement points.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026