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Clinical Trials/ACTRN12609000695202
ACTRN12609000695202
Completed
未知

Early Intensive Hand Rehabilitation After Spinal Cord Injury: Effect of a novel muscle-stimulator device versus standard treatment on hand function in participants with spinal cord injury.

The University of Melbourne0 sites78 target enrollmentAugust 12, 2009

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
The University of Melbourne
Enrollment
78
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 12, 2009
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • \* have sustained a Spinal Cord Injury (SCI)within the preceding 6 months from time of consent
  • \* are currently receiving inpatient rehabilitation through one of the study sites
  • \* will remain in hospital for 12 weeks after initial screening
  • \* are 16 years of age or older and able to provide informed consent
  • \* have a motor complete or incomplete spinal cord injury at the neurological level of C2 to T1 (as per the International Standardised Neurological Assessment for SCI)
  • \* can actively flex their target shoulder to 60 degrees
  • \* have reduced ability to grasp using the target hand
  • \* are able to tolerate sufficient Functional Electrical Stimulation (FES) to enable one hand to grasp and release
  • \* have the potential to benefit from FES and ReJoyce according to the judgment of the treating therapist

Exclusion Criteria

  • \* have any other type of neurological injury affecting the target hand (e.g. brachial plexus or peripheral nerve injuries)
  • \* have had recent trauma or surgery to the target hand or upper limb within the last 12 months
  • \* have had amputation of any digits on the target hand
  • \* are not able to sit out of bed each day for at least 2 hours over three consecutive days
  • \* have extensive fixed contractures in the upper limb of the target hand preventing use of the ReJoyce
  • \* have severe spasticity in the target hand or upper limb preventing use of the ReJoyce
  • \* are unable to attend the 6\-month and 1\-year follow\-up assessments at their treating spinal unit
  • \* are likely to undergo hand surgery in the target hand in the next year
  • \* are likely to experience autonomic dysreflexia and/or hypotension in response to electrical stimulation
  • \* have any contraindications to FES such as cardiac pacemaker, epilepsy, forearm fracture or pregnancy

Outcomes

Primary Outcomes

Not specified

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