Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01740128
First received: November 30, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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. Our 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 'thoracic' SCI - where legs are affected, but not the arms.

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

The first phase of the study will be observational - we 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 some ability to move their legs. Each person will undergo two different exercise rehabilitation strategies: weight-supported treadmill training; and balance training combined with skilled hand exercises.

We 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.

We hypothesize that participants with thoracic SCI undergoing combined balance/hand training will show improved outcomes when compared to traditional gait or balance training.


Condition Intervention
Spinal Cord Injuries
Paraplegia
Paraparesis
Device: Robotic body weight supported treadmill training
Other: Multimodal training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Hebbian Approach to Regaining Control of Spared Circuits in Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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); Eval #3 at 6-week follow-up ] [ Designated as safety issue: No ]
    Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes from baseline in Survery: Spinal Cord Injury - Quality of Life [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); ] [ Designated as safety issue: No ]
  • Changes from baseline in Survery: Spinal Cord Injury - Spasticity Evaluation Tool [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); ] [ Designated as safety issue: No ]
  • Changes from baseline in Survery: World Health Organization Quality of Life-Brief [ Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions); ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: January 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multimodal training
Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.
Other: Multimodal training
30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.
Other Name: balance exercises, skilled hand exercises
Active Comparator: Treadmill training
Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.
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 Name: Lokomat

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females age 21-65 years;
  • SCI duration > 12 months;
  • SCI level T1-T12;
  • All SCI severity eligible for baseline testing;
  • For exercise protocol, must have severity of Grade C or D on ASIA Impairment Scale, or volitional strength of at least 1/5 in two or more key lower extremity 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 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 SD 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740128

Contacts
Contact: Noam Y Harel, MD PhD (718) 584-9000 ext 1742 noam.harel@va.gov
Contact: Stephanie A Pena, BS (718) 584-9000 ext 3123 stephanie.pena@va.gov

Locations
United States, New York
James J. Peters VA Medical Center, Bronx, NY Recruiting
Bronx, New York, United States, 10468
Contact: Noam Y Harel, MD PhD    718-584-9000 ext 1742    noam.harel@va.gov   
Principal Investigator: Noam Y. Harel, MD PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Noam Y. Harel, MD PhD Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01740128     History of Changes
Other Study ID Numbers: B0881-W, 1IK2RX000881, 01407
Study First Received: November 30, 2012
Last Updated: August 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
spinal cord injuries
paraplegia
postural balance
locomotor activity
exercise therapy
electromyography
transcranial magnetic stimulation, single pulse

Additional relevant MeSH terms:
Spinal Cord Injuries
Paraplegia
Paraparesis
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms
Paresis

ClinicalTrials.gov processed this record on October 16, 2014