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Completed

NCT Number: NCT01740128

Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Paraparesis Paraplegia Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females age 21-65 years;
  • SCI duration > 12 months;
  • SCI level C2-T12;
  • All SCI severity eligible for baseline testing;
  • For exercise protocol, must have severity of Grade C or D on American Spinal Injury Association (ASIA) Impairment Scale, or volitional strength of at least 1/5 in two or more key lower extremity muscles, as well as at least 3/5 in both shoulder and elbow muscles;
  • Able to tolerate upright position with support;
  • Morphologically capable of fitting a weight-support harness and robotic treadmill system;
  • Ability to give informed consent.

Exclusion criteria

  • Unsuitable cognitive capacity as judged by the study physician;
  • Diagnosis of neurological injury other than SCI, such as stroke, traumatic brain injury, or other neurological condition that the study physician considers to be exclusionary;
  • Multiple spinal cord lesions;
  • History of frequent autonomic dysreflexia;
  • History of seizures;
  • Use of medications that significantly lower seizure threshold, such as anti-psychotics, tricyclic antidepressants, amphetamines, and bupropion;
  • History of implanted brain/spine/nerve stimulators, aneurysm clips, or cardiac pacemaker/defibrillator;
  • Deep vein thrombosis in lower extremities of less than 6 months duration;
  • Pregnancy;
  • (Interventional phase only): Lack of detectable tibialis anterior motor evoked potential (MEP) at baseline even with active facilitation;
  • (Interventional phase only): Pressure ulcers greater than stage 1 severity on the foot, ankle, knee and/or pelvic girdle;
  • (Interventional phase only): Bone mineral density of the hip (proximal femur) T-score <3.5 standard deviations from age- and gender-matched normative data;
  • (Interventional phase only): Any spasticity, contractures, or heterotopic ossification that result in inadequate range of motion of the shoulder, elbow, wrist, fingers, hip, knee, or ankle joints in the judgment of the study physician;
  • (Interventional phase only): Inability to cooperate with instructions or unwilling to commit to daily training sessions for 3-4 days per week over 12-16 weeks;
  • (Interventional phase only): A diagnosis of coronary artery disease that precludes moderate to intense exercise.

Treatment and study plan

Robotic body weight supported treadmill training

Device

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

Other names: Lokomat

Harness-supported multimodal balance training

Other

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

Other names: balance exercises, skilled hand exercises

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. Change From Baseline in ISNCSCI Lower Extremity Motor Score.

    Time frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

    Change between baseline and Evaluation #2 in lower extremity motor score derived from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Range of scores 0-50, higher is better.

  2. 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)

    Change between baseline and Evaluation #2 in Berg sitting unsupported subscore. Range 0-4, higher better.

  3. 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)

    Change between baseline and Evaluation #2 in modified Ashworth Scale. 0-4 score, lower is better.

  4. 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)

    Change between baseline and Evaluation #2 in gait speed during 10-meter walk test.

  5. 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)

    Change between baseline and Evaluation #2 in WISCI II score. Scores range 0-20, higher is better.

  6. 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)

    Change between baseline and Evaluation #2 in steps taken during 10-second step test.

  7. 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)

    Change between baseline and Evaluation #2 in McGill Pain Questionnaire (Subjective Domain). Total scale 0-45, lower is better.

  8. 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)

    Seated posturography performed using the "Limits of Stability" module of the Smart EquiTest apparatus (Neurocom) while seated. Directional Control measure.

  9. 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)

    Change between baseline and Evaluation #2 in soleus H-reflex facilitation by transcranial magnetic stimulation (TMS). Short-interval 0-20ms.

  10. Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)

    Time frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

    Change between baseline and Evaluation #2 in SCI-SET score. Range of scores -105 to +105. Higher is better.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Dec 4, 2012
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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