Clinical Trial: Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Hebbian Approach to Regaining Control of Spared Circuits in Spinal Cord Injury

Brief 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.


Detailed Summary:
Sponsor: VA Office of Research and Development

Current Primary Outcome: Change in motor evoked potential (MEP) amplitude in the tibialis anterior muscle at the end of training. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]

Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.


Original Primary Outcome: Change in motor evoked potential (MEP) area in the tibialis anterior muscle at the end of training. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]

Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.


Current Secondary Outcome:

  • Change from baseline in ASIA Impairment Scale (AIS) sensory scores. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Change from baseline in AIS lower extremity motor score. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Change from baseline in Berg Balance Scale sitting with back unsupported score. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Change in leg spasticity on modified Ashworth Scale [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Change in gait speed on 10-meter Walk Test. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Change from baseline in Walking Index for Spinal Cord Injury II (WISCI II) scale. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Change from baseline in total number of steps taken by both feet during seated 10-second step test. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Change in subjective pain as determined by McGill Pain Questionnaire (short form). [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Change from baseline in endpoint excursion and directional control parameters achieved during seated Limits of Stability testing. [ Time Frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
    Seated posturography performed using Smart EquiTest apparatus (Neurocom).
  • Change from baseline in soleus H-reflex facilitation. [ Time Frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Change from baseline in the Voluntary Response Index (VRI) for key leg muscles as detected by surface electromyography (Lee et al., 2004). [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Changes from baseline in Survey: Spinal Cord Injury - Quality of Life [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Changes from baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Changes from baseline in Survey: World Health Organization Quality of Life-Brief [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
  • Change in pinch strength dynamometry (for subjects with cervical-level SCI) [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change in grasp and release test performance (for subjects with cervical-level SCI) [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months); Eval #3 at 6-week follow-up ]
    Ability to grasp, move, and release two different objects as many times as possible within 30 seconds with left and right hand (average of three attempts each).


Original Secondary Outcome:

  • Change from baseline in ASIA Impairment Scale (AIS) sensory scores. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change from baseline in AIS lower extremity motor score. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change from baseline in Berg Balance Scale sitting with back unsupported score. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change in leg spasticity on modified Ashworth Scale [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change in gait speed on 10-meter Walk Test. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change from baseline in Walking Index for Spinal Cord Injury II (WISCI II) scale. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change from baseline in total number of steps taken by both feet during seated 10-second step test. [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change in subjective pain as determined by McGill Pain Questionnaire (short form). [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change from baseline in endpoint excursion and directional control parameters achieved during seated Limits of Stability testing. [ Time Frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
    Seated posturography performed using Smart EquiTest apparatus (Neurocom).
  • Change from baseline in soleus H-reflex facilitation. [ Time Frame: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]
  • Change from baseline in the Voluntary Response Index (VRI) for key leg muscles as detected by surface electromyography (Lee et al., 2004). [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); Eval #3 at 6-week follow-up ]


Information By: VA Office of Research and Development

Dates:
Date Received: November 30, 2012
Date Started: January 1, 2013
Date Completion: September 2017
Last Updated: February 24, 2017
Last Verified: February 2017