An interventional study of Myndmove in Traumatic Spinal Cord Injuries, sponsored by University of British Columbia. Terminated at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
Many individuals with cervical spinal cord injury (SCI) have difficulty using their hands and arms. MyndMove is a non-invasive medical device that uses short, low energy electrical pulses with surface electrodes to cause muscle contractions to produce a full range of reaching and grasping movements, which the patient is unable to perform by him/herself.
By using MyndMove therapy to help the individual move their arms and hands as he/she attempts to carry out typical reaching and grasping movements, the individual improves their ability to perform these tasks voluntarily.
The purpose of this study is to study the effectiveness of MyndMove therapy in improving the ability of individuals to move their arms and hands.
There is no control group for this study. Participants from both treatment groups:
will receive one session (60 minutes) of MyndMove therapy, 3 to 5 times per week (only once per day), to gain 20 hours of intervention (total treatment duration will be 4 to 7 weeks).
Each 1 hour session includes therapy for single-arm or bilateral (left and right upper extremities) as clinically indicated for each study participant. Over the course of 20 one hour sessions, participants will progress through the various movement sequences aimed at regaining natural, unassisted voluntary movement in the affected limb(s). The MyndMove therapy will be in addition to the conventional upper limb rehabilitation therapy the participant will be prescribed to undertake at their local institution.
From previous experience, the first signs of function recovery may be expected to emerge two to four weeks after the onset of the MyndMove therapy program. As soon as the participant shows signs of recovery of either the voluntary extension or flexion in a stimulated muscle group, s/he will be encouraged to make an effort to voluntarily produce the movement that was previously facilitated by FES. As the participant demonstrates improved strength and range of motion, the FES for that muscle group will be phased out, and moved to another muscle group that is still paralyzed and needs to be "reactivated". The order in which muscle groups will be sequentially "reactivated" will be patient dependent.
Muscle reactivation milestones will be monitored and recorded during MyndMove therapy. The number of MyndMove treatments required to reach each milestone will be recorded. In addition, the overall time required to reach each milestone will be recorded.
Total duration of study participation, including a follow-up assessment, will be approximately 4 to 5 months.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 9 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Initiate treatment with MyndMove device on or after 10 days to 6 months (182 days) post spinal cord injury
Device: Myndmove
Initiate treatment with MyndMove device on or after 6 months plus one day (183 days+) post spinal cord injury
Device: Myndmove
20 sessions of 1 hour treatments with the MyndMove device (functional electrical stimulation) to the muscles of the upper limb(s), conducted 3 to 5 times per week, over 4 to 7 weeks.
Change in participant's ability to do regular tasks of daily living as measured by the Spinal Cord Independence Measure (SCIM) questionnaire
This is a disability scale that has been specifically developed to evaluate the functional outcomes of patients with traumatic and non-traumatic SCI. The SCIM assesses function in three core areas: 1) Self-care, which includes feeding, bathing, dressing and grooming; 2) Respiration and sphincter management; and lastly 3) Mobility.
Time frame: Change from baseline to 4/7 weeks
Change in participant's upper limb and hand impairment and function using GRASSP (Graded Refined Assessment of Strength Sensibility Test).
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 4/7 weeks
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.
Time frame: Change from baseline to 4/7 weeks
Change in participant's grasp, grip, pinch and gross movement of the arm and upper limb using the Action Research Arm Test (ARAT).
A test developed to assess the upper limb function in stroke and SCI patients. It consists of four sub-tests: grasp, grip, pinch and gross movement.
Time frame: Change from baseline to 4/7 weeks
This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University of British Columbia