Multimodal Exercises to Improve Leg Function After Spinal Cord Injury
Spinal Cord Injuries, Paraplegia, Paraparesis
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injuries, paraplegia, postural balance, locomotor activity, exercise therapy, electromyography, transcranial magnetic stimulation, single pulse
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.
Sites / Locations
- James J. Peters VA Medical Center, Bronx, NY
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Multimodal then Treadmill training
Treadmill then Multimodal training
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.
Robotic body weight supported treadmill training will be applied using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.