Feasibility and Efficacy of Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation for Neurorestoration of Upper Limbs After Cervical Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- International Standards of Neurological Classification of SCI (ISNCSCI)
Study Overview
Brief 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.
Detailed Description
The ABT-TCSCS is a one-arm interventional study evaluating the feasibility and efficacy of activity-based therapy and transcutaneous spinal cord stimulation on neurorestoration of upper limbs after cervical spinal cord injury. Up to 24 individuals with SCI who suffer from tetraplegia will be treated with ABT-TCSCS. All participants will receive 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. All study participants will be assessed at the start of the study (Baseline 1) and then re-assessed after 6 weeks (Baseline 2) to ensure that they are neurologically stable. The baseline assessment will consist of the International Standards of Neurological Classification of SCI (ISNCSCI), GRASSP Version 1, the Spinal Cord Independence Measure (SCIM) and the TRI hand function test (TRI-HFT). Participants will be re-assessed after receiving 12 sessions of ABT i.e after 4 weeks (Pre-cervical stimulation assessment) and then after receiving 28 sessions of combined ABT and neuromodulation i.e after 7 weeks (Post-intervention assessment).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •A score between 5 - 40 on GRASSP Version 1 Strength on at least one side
- •Individuals who are medically stable
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
International Standards of Neurological Classification of SCI (ISNCSCI)
Time Frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
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).
TRI hand function test (TRI-HFT)
Time Frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
TRI-HFT will be used as a measure of functional and performance change before and after intervention.
Tactile Discrimination Test (TDT)
Time Frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
The TDT will be used to measure of ability to discriminate differences in finely graded texture.
Spinal Cord Independence Measure (SCIM)
Time Frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
The SCIM is a measure of independence and defines how much gain in global function one makes.
Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) Version 1
Time Frame: At enrollment, 4-6 weeks after enrollment, after 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS
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.
Secondary Outcomes
- Neurophysiological Assessment using surface electromyography (EMG)(After 4 weeks (12 sessions) of ABT, and after 7 weeks (28 sessions) of ABT-TCSCS)
Investigators
Sukhvinder Kalsi-Ryan
Lead of the KITE Rehabilitation and Innovation Clinics-Lyndhurst Site
University Health Network, Toronto