Traumatic Spinal Cord Injuries Clinical Trial
Official title:
Recovery of Upper Limb Function in Persons With Spinal Cord Injury: Lead-In Study
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:
- Early treatment group = 10 days to 6 months post tSCI and
- Late treatment group = 6 months plus one day post tSCI
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.
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