Early Intensive Hand Rehabilitation After Spinal Cord Injury (SCIPAHandsOn)

University of Melbourne

Status and phase: Completed; Phase 3

Conditions: Spinal Cord Injury

Treatments: Device: ReJoyce Workstation; Other: Standard Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01086930

SCIPA Hands-On

Details and patient eligibility

About

Loss of hand function is one of the most devastating consequences of tetraplegia because of the severe impact on activities of daily living (ADL) and the resultant dependency on others. This multi-centre study in 78 participants will measure whether additional hand therapy provided via an electrical stimulator glove and specialised computer workstation improves hand function in people with tetraplegia.

Full description

The study is a multi-centre, assessor-blind, randomised controlled phase III trial in patients with tetraplegia (a spinal cord injury). A total of 78 participants will be randomised into two groups; 1. the experimental group and 2. the control group. The control group will receive their standard rehabilitation care, while the experimental group will receive the standard rehabilitation care plus the study treatment. The study treatment will consist of one hour of extra hand training, 5 times a week, using a specialised glove which provides electrical impulses to the patient's hand allowing them to open and close their hand. The glove will be used to play games on a specialised computer workstation which focuses on hand movement and function.

The main objective of this study is to determine if the experimental treatment is more effective than standard rehabilitation care alone in participants with tetraplegia.

Total study duration is 3 years, including an 18 month recruitment period, an 8-week treatment period followed by 6 month and 12 month follow up assessments.

The progress of the participant's therapy during the study will be assessed by a blinded assessor (the assessor will not know which group the participants are in) using standard physiotherapy and occupational therapy assessments which focus on hand function. These involve grasping and releasing different everyday objects and performing everyday tasks as well as quality of life questionnaires.

Enrollment: 70 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients will be included if they:

1. have sustained a SCI within the preceding 6 months from time of consent
2. are currently receiving inpatient rehabilitation through one of the study sites
3. will remain in hospital for 12 weeks after initial screening as part of their standard medical/rehabilitation care
4. are 16 years of age or older and able to provide informed consent
5. 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)
6. can actively flex their shoulder/s to 60 degrees
7. have reduced ability to grasp using their hands
8. are able to tolerate sufficient FES to enable one hand to grasp and release
9. have the potential to benefit from FES and ReJoyce according to the judgment of the treating therapist

Exclusion criteria

Patients will not be included if they:

1. have any other type of neurological injury affecting the target hand (e.g. brachial plexus or peripheral nerve injuries)
2. have had recent trauma or surgery to the target hand or upper limb within the last 12 months
3. have had amputation of any digits on the target hand
4. are not able to sit out of bed each day for at least 2 hours over three consecutive days
5. have extensive fixed contractures in the upper limb of the target hand preventing use of the ReJoyce
6. have severe spasticity in the target hand or upper limb preventing use of the ReJoyce
7. are unable to attend the 6-month and 1-year follow-up assessments at their treating spinal unit
8. are likely to undergo hand surgery in the target hand in the next year
9. might experience autonomic dysreflexia and/or hypotension in response to electrical stimulation
10. have any contraindications to FES, such as cardiac pacemaker, epilepsy, forearm fracture or pregnancy
11. have intracranial metal implants
12. have impaired vision and/or are unable to view a computer screen
13. have any other serious medical condition including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant's ability to cooperate or in the opinion of the study investigator would prevent the participant from adhering to the Protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Intervention Group

Experimental group

Description:

In addition to standard care participants in Group A will receive: • One hour of extra hand training five times per week for 8 weeks using the ReJoyce Workstation. The training will be supervised by a therapist and provided to the target hand. The hand exercises will be incorporated into computer games and will involve the following tasks using different manipulanda: * reaching * grasping * manipulating * pulling * rotating * releasing

Treatment:

Other: Standard Care

Device: ReJoyce Workstation

Standard Care Group

Other group

Description:

Participants in the control group will not receive any training on the instrumented workstation or electrical stimulation to the hand or upper limb. They will however continue to receive standard care as well as three 15-minute specific hand activity sessions per week specifically devoted to the practice of hand activities in a one-to-one format with a therapist (as per the treatment received by the experimental group).

Treatment:

Other: Standard Care