Exoskeleton and Spinal Cord Stimulation for SCI
Spinal Cord Injury, Ambulation Difficulty, Muscle Spasticity
About this trial
This is an interventional supportive care trial for Spinal Cord Injury focused on measuring Spinal Cord injury (SCI), Transcutaneous lumbosacral stimulation (TLS), Exoskeleton-Assisted Walking (EAW)
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study a participant must:
- be a non-walker with an SCI greater than 6 years post injury;
- have a lower extremity motor score greater or equal to 16 as measured by the International Standards for Neurological Classification of SCI exam;
- be between the ages of 21-58 years old;
- have a spinal cord injury at a neurological level of injury as determined by study staff between C6-T-10;
- be wheelchair reliant 100% of the time;
- have knee bone mineral density great than .5755gm/cm2 as determined by study staff;
- have a height between 62 inches to 74 inches.
Exclusion Criteria:
- have a history of broken or fractured bones.
- have a history of bone trauma or bone disease.
Sites / Locations
- Kessler FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
EAW + TLS
EAW without TLS
The EAW+TLS training group will receive 60 minutes of exoskeleton-assisted walking overground per session, for a total of 80 sessions (3x/week, 28 wks.) with simultaneous transcutaneous lumbosacral stimulation (TLS) intervention followed by 15 minutes of over ground training without the exoskeleton. component is added to the exoskeleton assisted walking component in this group. TLS will involve placing self-adhesive stimulating electrodes bilaterally over the T11/T12 lumbar region. Correct placement will be confirmed by the elicitation of posterior root muscle reflexes in the lower limb muscles. A constant-voltage stimulator (RT 50 Sage stimulator) will deliver pulses of 2 ms width. TLS will be applied while the participant walks in the Exo-skeleton-assisted walking (EAW).
EAW, exoskeleton-assisted walking, an activity based therapy is a training which involves using the same exoskeleton device for all the participants. Each participant will undergo, 60 minutes of EAW as above. Each participant will undergo a stand evaluation and be instructed in proper use of the device. During the initial 3 sessions of training, the exoskeleton device will be tethered to an overhead pulley system during training to allow subjects to safely adapt to trunk, balance gait activities while walking in the exoskeleton. EAW overground walking will follow each training session with the 6-minute walk test, 10 meter walk test .