Recovery of Upper Limb Function in Persons With Spinal Cord Injury: Lead-In Study

Launched by UNIVERSITY OF BRITISH COLUMBIA · Jun 9, 2016

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Traumatic incomplete (AIS B-D) C4-C7 SCI
• • 2. Early treatment group = 10 days to 6 months (182 days) post tSCI (note it is expected that most ppts will be recruited from this group, while at GF Strong)
• • 3. Late treatment group = initiate treatment on or after 6 months plus one day (183 days+) post tSCI
• • 4. SCIM self-care sub-score ≤ 10
• • 5. Able to understand and follow instructions
• • 6. Able to be in a seated position for a least one hour of upper limb therapy
• • 7. Able to attend the study treatment sessions
• • 8. Able to provide informed consent
• • 9. Men and women of the age of majority in their province or state
• Exclusion Criteria:
• • 1. Previous history of any other neurological disorder or conditions that may affect motor response
• • 2. Upper extremity injury or condition prior to SCI that limits the function of the hand or arm
• • 3. Malignant skin lesion on the affected upper extremity
• • 4. History of seizure disorder not effectively managed by seizure medications
• • 5. An existing electrical stimulation devices (e.g. ICD, Pacemaker, Spinal Stimulation)
• • 6. Rash or open wound at any potential electrode site
• • 7. Denervation of muscles that are targeted by MyndMove
• • 8. Poorly controlled autonomic dysreflexia (as determined by the local site physician)
• • 9. In the judgment of the local site physician, participant has medical complications that may interfere with the execution of the study
• • 10. Botulinum toxin injection into affected upper extremity within 3 months prior to the study start. No botulinum toxin injections during the study treatment and follow up period.
• • 11. Currently enrolled in another upper limb study
• • 12. Enrolled, in the past six months, in a clinical study involving drugs or biologics