Early Intensive Hand Rehabilitation After Spinal Cord Injury

NCT01086930 | Completed Phase 3 DMC

• 1 other identifier: SCIPA Hands-On
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 7

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Modified Action Research Arm Test

  A standardized measure of unilateral hand and upper limb function

  8 weeks and 26 weeks

Secondary Outcomes (10)

• Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension

  8 weeks and 26 weeks

• Sensory Score on ISNCSCI

  8 weeks and 26 weeks

• AsTex Sensory Test

  8 weeks and 26 weeks

• AuSpinal Test

  8 weeks and 26 weeks

• Capabilities of Upper Extremity

  8 weeks and 26 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Device: ReJoyce Workstation; Other: Standard Care

Standard Care Group

OTHER

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).

Other: Standard Care

Interventions

ReJoyce Workstation DEVICE

The device has two parts. A muscle-stimulator garment that incorporates a wireless-triggered stimulator cuff and an earpiece, similar to a hearing aid, that sends a radio signal to the stimulator cuff. As well as a specialised workstation known as ReJoyce, which connects to a standard computer via a USB port. This work station will allow the user to play specialised computer games focusing on hand function. The stimulator system and the ReJoyce workstation were developed by Professor Arthur Prochazka, University of Alberta, Canada and has been approved by the Canadian Standards Association.

Intervention Group

Standard Care OTHER

All participants will continue to receive the same standard care for the hand and upper limb as typically provided by their rehabilitation units.

Intervention Group; Standard Care Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be included if they:
• have sustained a 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 as part of their standard medical/rehabilitation care
• 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 shoulder/s to 60 degrees
• have reduced ability to grasp using their hands
• are able to tolerate sufficient 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

You may not qualify if:

• Patients will not be included if they:
• 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
• might 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
• have intracranial metal implants
• have impaired vision and/or are unable to view a computer screen
• 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.

Sponsors & Collaborators

• University of Melbourne: lead
• Austin Hospital, Melbourne Australia: collaborator
• Hampstead Rehabilitation Centre Adelaide: collaborator
• Shenton Park Rehabilitation Centre Perth: collaborator
• Princess Alexandra Hospital, Brisbane, Australia: collaborator
• Royal Rehabilitation Centre Sydney: collaborator
• Prince of Wales Hospital, Sydney: collaborator
• Burwood Hospital, Christchurch, New Zealand: collaborator

Study Sites (7)

Spinal Unit, Prince of Wales Hospital

Randwick, New South Wales, Australia

Location

Royal Rehabilitation Centre Sydney

Sydney, New South Wales, Australia

Location

Queensland Spinal Cord Injury Service, Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Location

South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre

Northfield, South Australia, Australia

Location

Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre

Kew, Victoria, 3101, Australia

Location

Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital

Shenton Park, Western Australia, Australia

Location

Burwood Academy

Christchurch, New Zealand

Location

Related Publications (3)

• 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.

  PMID: 21235821 BACKGROUND

• 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.

  PMID: 27008910 RESULT

• 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.

  PMID: 28970100 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lisa Harvey

  University of Sydney

  PRINCIPAL INVESTIGATOR

• Mary Galea

  University of Melbourne

  PRINCIPAL INVESTIGATOR

• Sarah Dunlop

  The University of Western Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 15, 2010
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: September 1, 2015
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (6); NZ (1)