Activity Dependent Rehabilitation Model to Improve Bone and Muscle Outcomes
Disuse Osteoporosis, Atrophy, Disuse, Nervous System
About this trial
This is an interventional treatment trial for Disuse Osteoporosis focused on measuring bone turnover, muscle atrophy, fiber
Eligibility Criteria
Inclusion Criteria:
- Must be between 18 and 58 years old with a neurological SCI level between the C6-T10 level and an impairment grade A, B, or C, according to the American Spinal Injury Association (ASIA) Impairment scale.
- Must have a spinal cord injury that is greater than 6 month or less than 2 years post injury
- Must have score less than 3 on the Modified Ashworth Scale.
- Must be able to tolerate electrical stimulation and must show visible muscle contraction to electrical stimulus
- Must be wheelchair reliant for more than 75% of the time
Exclusion Criteria:
- Bone density measurement (as recorded by the researcher) for knee at or below 0.5755 gm/cm2
- Weigh more than 225 Ibs.
- Taller than 6 feet 3 inches
- Post -menopausal, pregnant or a lactating woman.
Sites / Locations
- Kessler FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Placebo Comparator
Experimental
Electrical Stimulation Alone Group
Stand Retraining Alone with BWS
Stand Retraining and ES Group
Group 1 will receive 1hr of electrical stimulation while lying down followed by 15 min of overground training. Electrical stimulation will be applied through leads and self-adhesive electrodes over muscles of both legs. Two electrodes will be used for each muscle. Electrical stimulation will be induced by using the EMPI, Inc., St. Paul, MN [Respond Select Neuromuscular Stimulation]. There will be 60 sessions/3x week for 20 weeks.
Group 2 will receive standing retraining with BWS alone on a treadmill without functional electrical stimulation. Locomotor training consists of (step training and stand retraining) on the treadmill, over ground training, and community ambulation. BWS will be given when a subject can not maintain his/her body weight while executing limb locomotion. BWS will be given when a subject can not maintain his/her body weight while executing limb locomotion. The duration of stand retraining sessions will be up to 1 hour or determined by subject's fatigue. There will be 60 sessions/3x week for 20 weeks.
Group 3 will receive standing retraining with BWS with electrical stimulation, followed by 15 min of overground training. Locomotor training consists of (step training and stand retraining) on the treadmill, over ground training, and community ambulation. BWS will be given when a subject can not maintain his/her body weight while executing limb locomotion. Electrical stimulation will start while participant is seated and before he/she is brought up to full standing. There will be 60 sessions/3x week for 20 weeks.