Clinical trial NCT01086930: Early Intensive Hand Rehabilitation After Spinal Cord Injury
Official title: SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Cord Injury
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Austin Hospital, Melbourne Australia
name: Hampstead Rehabilitation Centre Adelaide
name: Shenton Park Rehabilitation Centre Perth
name: Princess Alexandra Hospital, Brisbane, Australia
name: Royal Rehabilitation Centre Sydney
name: Prince of Wales Hospital, Sydney
name: Burwood Hospital, Christchurch, New Zealand
First posted: 2010-03-15
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Action Research Arm Test
timeFrame: 8 weeks and 26 weeks
Secondary outcomes:
measure: Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension
timeFrame: 8 weeks and 26 weeks
measure: Sensory Score on ISNCSCI
timeFrame: 8 weeks and 26 weeks
measure: AsTex Sensory Test
timeFrame: 8 weeks and 26 weeks
measure: AuSpinal Test
timeFrame: 8 weeks and 26 weeks
measure: Capabilities of Upper Extremity
timeFrame: 8 weeks and 26 weeks
measure: Assessment of Quality of Life (AQoL)
timeFrame: 8 weeks and 26 weeks
measure: Health Utilities Index Mark 3
timeFrame: 8 weeks and 24 weeks
measure: Self-care subscale of the Spinal Cord Independence Measure
timeFrame: 8 weeks and 24 weeks
measure: Goal Attainment Scale
timeFrame: 8 weeks
measure: Participant Perception of Treatment Effectiveness
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Spinal Unit, Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal Rehabilitation Centre Sydney
state: New South Wales
city: Woolloongabba
country: Australia
facility: Queensland Spinal Cord Injury Service, Princess Alexandra Hospital
state: Queensland
city: Northfield
country: Australia
facility: South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre
state: South Australia
city: Kew
country: Australia
facility: Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre
state: Victoria
city: Shenton Park
country: Australia
facility: Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital
state: Western Australia
city: Christchurch
country: New Zealand
facility: Burwood Academy
Study officials:
affiliation: University of Sydney
name: Lisa Harvey
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Melbourne
name: Mary Galea
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Western Australia
name: Sarah Dunlop
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harvey LA, Dunlop SA, Churilov L, Hsueh YS, Galea MP. Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial. Trials. 2011 Jan 17;12:14. doi: 10.1186/1745-6215-12-14.
citation: Harvey LA, Dunlop SA, Churilov L, Galea MP; Spinal Cord Injury Physical Activity (SCIPA) Hands On Trial Collaborators. Early intensive hand rehabilitation is not more effective than usual care plus one-to-one hand therapy in people with sub-acute spinal cord injury ('Hands On'): a randomised trial. J Physiother. 2016 Apr;62(2):88-95. doi: 10.1016/j.jphys.2016.02.013. Epub 2016 Mar 19.
citation: Harvey LA, Dunlop SA, Churilov L, Galea MP; Spinal Cord Injury Physical Activity (SCIPA) Hands On Trial Collaborators. Early intensive hand rehabilitation is not more effective than usual care plus one-to-one hand therapy in people with sub-acute spinal cord injury ('Hands On'): a randomised trial. J Physiother. 2017 Oct;63(4):197-204. doi: 10.1016/j.jphys.2017.08.005. Epub 2017 Sep 29.