The impact of sacral sensory sparing in motor complete spinal cord injury.
Steven Kirshblum, Amanda Botticello, Daniel P Lammertse...
https://pubmed.ncbi.nlm.nih.gov/21353822Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06472986
Feasibility and Efficacy of Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation for Neurorestoration of Upper Limbs After Cervical Spinal Cord Injury
Led by University Health Network, Toronto · Updated on 2024-07-09
24
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
O
Ontario Neurotrauma Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how activity-based therapy combined with transcutaneous spinal cord stimulation can help improve arm and hand function after cervical spinal cord injury. This one-arm interventional study focuses on neurorestoration for individuals with tetraplegia due to chronic traumatic or non-traumatic cervical spinal cord injury. The study aims to assess both the feasibility and potential benefits of these therapies for upper limb recovery. Participants will undergo 12 sessions of activity-based therapy over 4 weeks, followed by 28 sessions combining activity-based therapy with transcutaneous spinal cord stimulation over 7 weeks. Each session lasts one hour and is conducted three times a week. The stimulation is applied at specific cervical spinal levels to modulate motor commands controlling the muscles. This combined approach includes exercises such as cardio-fitness, resistance, postural, weightbearing, and functional movements. Throughout the study, participants will be assessed multiple times: at the start, after 6 weeks to confirm neurological stability, after the initial 12 sessions of activity-based therapy, and after the combined therapy sessions. Assessments include neurological classification, strength and sensation testing, independence measures, hand function tests, and neurophysiological evaluations using electromyography. These evaluations will help determine functional changes and therapy feasibility over the total study duration of approximately 11 weeks.
CONDITIONS
Brief Title
Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation After Spinal Cord Injury (ABT-TCSCS)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Individuals with chronic traumatic or non-traumatic cervical spinal cord injury classified as ASIA A-incomplete, B, C, or D between levels C1 and C8
- Adults aged 18 years or older
- At least 6 months post-spinal cord injury
- Upper extremity motor score on ISNCSCI between 2 and 15
- GRASSP Version 1 strength score between 5 and 40 on at least one side
- Medically stable individuals
You will not qualify if you...
- Individuals with any other upper extremity deficits besides spinal cord injury
- Unable to provide informed consent
- Unable to participate in an intensive outpatient rehabilitation program
- Spasticity limiting elbow or wrist range of motion by more than 50%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Baseline Assessment
Duration - 6 weeks
Participants undergo initial neurological and functional assessments to establish baseline stability before intervention.
2 visits (Baseline 1 and Baseline 2 assessments)
Treatment
Duration - 11 weeks
Participants receive 12 sessions of activity-based therapy (ABT) over 4 weeks, followed by 28 sessions combining ABT and transcutaneous spinal cord stimulation (TCSCS) over 7 weeks.
3 sessions per week, each lasting 1 hour
Assessments During Treatment
Duration - During treatment period
Participants are reassessed after 4 weeks of ABT and after 7 weeks of combined ABT-TCSCS to evaluate neurological and functional progress.
2 assessment visits (after 4 weeks and after 7 weeks of treatment)
Trial Site Locations
Total: 1 location
1
Toronto Rehabilitation Institute
Toronto, Ontario, Canada, M4G 3V9
Actively Recruiting
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Research Team
U
Urvashy Gopaul, PhD
G
Gita Gholamrezaei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Upper- and lower-extremity motor recovery after traumatic cervical spinal cord injury: an update from the national spinal cord injury database.
Ralph J Marino, Stephen Burns, Daniel E Graves...
https://pubmed.ncbi.nlm.nih.gov/21353821Development of the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP): reviewing measurement specific to the upper limb in tetraplegia.
Sukhvinder Kalsi-Ryan, Armin Curt, Mary C Verrier...
https://pubmed.ncbi.nlm.nih.gov/22985372Characteristics of Upper Limb Impairment Related to Degenerative Cervical Myelopathy: Development of a Sensitive Hand Assessment (Graded Redefined Assessment of Strength, Sensibility, and Prehension Version Myelopathy).
Sukhvinder Kalsi-Ryan, Lauren E Riehm, Lindsay Tetreault...
https://pubmed.ncbi.nlm.nih.gov/31792501Toronto rehabilitation institute-hand function test: assessment of gross motor function in individuals with spinal cord injury.
Naaz Kapadia, Vera Zivanovic, Molly Verrier...
https://pubmed.ncbi.nlm.nih.gov/23459270Combined Activity-Based Therapy and Cervical Spinal Cord Stimulation: Active Ingredients, Targets and Mechanisms of Actions to Optimize Neurorestoration of Upper Limb Function After Cervical Spinal Cord Injury.
Urvashy Gopaul, Mark Theodore Bayley, Sukhvinder Kalsi-Ryan
https://pubmed.ncbi.nlm.nih.gov/39927575