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Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

NCT01740128 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-02-26

Study results available
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Summary

Many people with spinal cord injury (SCI) retain at least some movement below their injury, but their muscles often have a 'mind of their own'. Typical exercise programs focus on keeping muscles strong and flexible, but don't usually focus on helping patients control their muscles. The investigators' exercise research study will compare two different programs with the specific goal of improving conscious control of patients' muscles below the injury. This study focuses on those with 'chronic' SCI - the injury occurred at least one year prior to enrolling.

This is a single center study taking place in the Bronx, NY.

The first phase of the study will be observational - the investigators will analyze which nerve connections might remain partially intact through the injury (even if the nerves aren't consciously controlled). Participants with all severity of SCI may participate in this first phase.

The second phase of the study will involve people who retain at least slight ability to move their legs and the ability to move the arms against gravity. Each person will undergo two different exercise rehabilitation strategies: weight-supported treadmill training; and balance training combined with skilled arm or hand exercises.

The investigators will compare the effects of these exercise programs on a variety of outcomes, including gait speed, balance, strength, and muscle activation in response to brain stimulation.

The investigators hypothesize that participants with chronic SCI undergoing combined balance/arm/hand training will show improved outcomes when compared to traditional gait or balance training.

Conditions

  • Spinal Cord Injuries
  • Paraplegia
  • Paraparesis

Interventions

DEVICE

Robotic body weight supported treadmill training

30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

OTHER

Harness-supported multimodal balance training

30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Noam Y Harel, MD PhD · James J. Peters Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2016-11-30
Completion
2017-10-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01740128 on ClinicalTrials.gov