Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation After Spinal Cord Injury (ABT-TCSCS)
NCT Number: NCT06472986
Acronym: ABT-TCSCS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injuries|Spinal Cord Injury Cervical
Interventions: OTHER: Activity-based therapy and transcutaneous spinal cord stimulation
Sponsor: University Health Network, Toronto
Collaborators: Ontario Neurotrauma Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-10-07
Completion Date: 2027-06-30
Locations: Toronto Rehabilitation Institute, Toronto, Ontario, M4G 3V9, Canada

Summary:
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.

Primary Outcome Measures: 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)., At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS|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., At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS|Spinal Cord Independence Measure (SCIM), The SCIM is a measure of independence and defines how much gain in global function one makes., At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS|TRI hand function test (TRI-HFT), TRI-HFT will be used as a measure of functional and performance change before and after intervention., At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS|Tactile Discrimination Test (TDT), The TDT will be used to measure of ability to discriminate differences in finely graded texture., At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
Secondary Outcome Measures: 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., After 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS