Background: Improving hand and arm function is an important goal for individuals with cervical spinal cord injury (cSCI). Activity Based Therapy (ABT) is a neurorestorative approach that incorporates a high intensity, long duration and effortful engagement to garner sensory-motor improvements. Spinal cord stimulation is a neuromodulation modality that can restore sensory-motor function. Spinal cord stimulation can elevate the excitability of the spinal neural network and potentially enhance the neurorestorative benefits of ABT. However, there is scarce evidence on the combined effects of ABT and spinal cord stimulation on UL recovery after cSCI.
Objective: This report aims to describe how theory informed the design and development of a Phase 1 study on a new UL intervention combining ABT and transcutaneous cervical spinal cord stimulation (tCSCS) (short form:ABT-tCSCS) delivered simultaneously for individuals with cSCI.
Method: The design of the ABT-tCSCS was guided by theory-based frameworks such as the Rehabilitation treatment specification system and the Template for Intervention Description and Replication guide. The ABT-TCSCS aimed to improve somatosensory-motor deficits and function in the UL after cSCI. The ABT-tCSCS intervention was developed through the following stages: (a) Description of the active ingredients, mechanism of action, and targets of the ABT-tCSCS; (b) Tailoring of ABT-tCSCS; and (c) Development of treatment regimen guidelines for the delivery of the ABT-tCSCS.
Results: ABT constitutes 4 types of exercises, including cardio-fitness, resistance, postural/weightbearing, and functional exercises, for activation of the neuromuscular system below the level of lesion to target somatosensory-motor impairments. In tCSCS, electrical stimulation is delivered at a frequency of 30-50 Hz at 500-1000 μs between C3-C7. The spinal neural networks of the cervical region are stimulated to neuromodulate the descending motor commands which control the muscles. ABT-tCSCS will be delivered simultaneously over 28 sessions (1 h/session, 3x/week over 9-10 weeks).
Conclusions: Combined ABT-tCSCS is a new intervention for neurorestoration of the upper limbs after cSCI.
Trail Registration: ClinicalTrials.gov ID: NCT06472986.
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