Multimodal Exercises to Improve Leg Function After Spinal Cord Injury
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 11/19/2017 |
| Start Date: | January 1, 2013 |
| End Date: | September 30, 2017 |
A Hebbian Approach to Regaining Control of Spared Circuits in 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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
