Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation After Spinal Cord Injury (ABT-TCSCS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
The ABT-TCSCS study investigates how feasible and beneficial are activity-based therapy and transcutaneous spinal cord stimulation on improving of arm and hand recovery after cervical spinal cord injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals with chronic traumatic and non-traumatic cervical SCI (ASIA classification A-incomplete**, B, C, D) between C1-C8
Adults more than 18 years old
At least 6 months post-spinal cord injury
A score of 2 - 15 on the upper extremity motor score of the ISNCSCI
Disqualifiers
Individuals with any other upper extremity deficit
Unable to provide informed consent
Unable to participate in an intensive rehabilitation outpatient program
Spasticity that limits the range of motion greater than 50% for the elbow or wrist
Trial design
Design model
Single group
Treatments tested in this trial
Activity-based therapy and transcutaneous spinal cord stimulation
Other interventionActivity Based Therapy (ABT) is a method of neuro-rehabilitation that incorporates a high intensity, long duration and effortful engagement from the individual receiving therapy, to garner improvements in sensory and motor function. The ABT constitutes 4 types of exercises including: cardio-fitness, resistance, postural/weightbearing and functional exercises. TransCutaneous Spinal Cord Stimulation (TCSCS) stimulates spinal networks in the cervical region to neuro-modulate the descending motor commands/motor intentions from the brain, which control the muscles. In tCSCS, electrical stimulation is delivered at a frequency of 30-50Hz at 500-1000µs between C3-C7. 12 sessions of ABT (4 weeks), followed by 28 sessions of ABT-TCSCS (7 weeks). Each session will last 1 hour and delivered 3 times per week.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: ABT-TCSCSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
International Standards of Neurological Classification of SCI (ISNCSCI)
The ISNCSCI will be used to establish severity of injury, classify the sample and establish inclusion for study to be administered by clinicians. The ISNCSCI evaluates both motor and sensory impairment to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. The severity of injury is graded as ASIA A = Complete, B (Sensory Incomplete), C (Motor Incomplete), D (Motor Incomplete), E (Normal).
Time frame
At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS2
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Version 1
The GRASSP Version 1 evaluates sensorimotor and prehension function of upper extremity impairment and hand function through three domains: Strength, Sensation and Prehension. It will be administered by clinicians and takes about 30-45 minutes to complete.
Time frame
At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS3
Spinal Cord Independence Measure (SCIM)
The SCIM is a measure of independence and defines how much gain in global function one makes.
Time frame
At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS4
TRI hand function test (TRI-HFT)
TRI-HFT will be used as a measure of functional and performance change before and after intervention.
Time frame
At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCSSecondary outcomes
1
Neurophysiological Assessment using surface electromyography (EMG)
Neurophysiological Assessment using surface EMG will be used to determine the responses to ABT and TCSCS in multiple upper limb muscles. sEMG responses to cervical spinal stimulation will be recorded simultaneously in multiple upper limb muscles unilaterally on the 1) deltoid anterior, 2) deltoid posterior, 3) biceps brachii, 4) triceps brachii, 5) flexor carpi radialis, 6) extensor carpi radialis, 7) abductor pollicis brevis, and 8) first dorsal interosseous muscles.
Time frame
After 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCSSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Health Network, Toronto
Lead sponsor
Ontario Neurotrauma Foundation
Collaborator
Source ClinicalTrials.gov