Overview

This trial is active, not recruiting.

Conditions spinal cord injuries, paraplegia, paraparesis
Treatments robotic body weight supported treadmill training, multimodal training
Sponsor VA Office of Research and Development
Start date January 2013
End date June 2016
Trial size 75 participants
Trial identifier NCT01740128, 01407, 5IK2RX000881-03, B0881-W, SPU-11-077

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.
multimodal training balance exercises, skilled hand exercises
30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.
(Active Comparator)
Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.
robotic body weight supported treadmill training Lokomat
30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

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 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 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.

Additional Information

Official title A Hebbian Approach to Regaining Control of Spared Circuits in Spinal Cord Injury
Principal investigator Noam Y Harel, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.