A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms and hands from an incomplete, traumatic spinal cord injury.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
51
This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function
Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.
MetroHealth Medical Center / Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States
TIRR Memorial Hermann
Houston, Texas, United States
HealthTech Connex Centre for Neurology Studies / NeuroMotion Physiotherapy Clinics ( Surrey, Vancouver and Victoria)
Surrey, British Columbia, Canada
Toronto Rehabilitation Institute
Toronto, Ontario, Canada
To compare the efficacy of MyndMove® therapy vs intensive conventional therapy in improving upper extremity function as measured by Spinal Cord Independence Measure self-care sub score (SCIM-SC)
SCIM-SC is a disability scale that has been specifically developed to evaluate the functional outcomes of patients with traumatic and non-traumatic SCI. The SCIM-SC assesses function of self-care, which includes feeding, bathing, dressing and grooming.
Time frame: Change from baseline to 6weeks to 14 weeks to 24weeks
Change in participant's upper limb and hand impairment and function using Graded Refined Assessment of Strength Sensibility and Prehension (GRASSP)
This is a multi-modality test designed to assess the integration of sensorimotor hand and upper limb impairment and function. This test combines the features of several other tests that have been used to assess hand and upper limb function in the peripheral hand population
Time frame: Change from baseline to 6weeks to 14weeks to 24weeks
Change in participant's reaching and grasping function with the Toronto Rehab Institute Hand Function Test (TRI-HFT)
A test developed to evaluate improvements in the gross motor function of the unilateral grasp due to FES for reaching and grasping treatment. Hand functions that will be tested with the TRI-HFT are: lateral or pulp pinch, and palmar grasps. that have been used to assess hand and upper limb function in the peripheral hand population
Time frame: Change from baseline to 14 weeks to 24weeks
To assess safety as measured by serious and non serious adverse events (SAEs) recorded for participants in both groups of the study population over the duration of the study
Time frame: Duration of the trial from baseline to 24weeks
Change in quality of life as measured by the Spinal Cord Injury-Quality of Life (SCI-QOL)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The SCI-QOL measurement system is a multifaceted system of measuring patient reported outcomes across a wide variety of functioning specifically targeted for individuals with SCI
Time frame: Change from baseline to 6weeks to 14weeks to 24weeks