Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

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Brief Title

Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

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.
    



Study Type

Interventional


Primary Outcome

Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.

Secondary Outcome

 Change From Baseline in ISNCSCI Lower Extremity Motor Score.

Condition

Spinal Cord Injuries

Intervention

Robotic body weight supported treadmill training

Study Arms / Comparison Groups

 Multimodal then Treadmill training
Description:  Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

21

Start Date

January 1, 2013

Completion Date

October 23, 2017

Primary Completion Date

November 30, 2016

Eligibility Criteria

        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.
      

Gender

All

Ages

21 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Noam Y Harel, MD PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01740128

Organization ID

B0881-W

Secondary IDs

5IK2RX000881-03

Responsible Party

Sponsor

Study Sponsor

VA Office of Research and Development


Study Sponsor

Noam Y Harel, MD PhD, Principal Investigator, James J. Peters Veterans Affairs Medical Center


Verification Date

January 2018