Early Intensive Hand Rehabilitation After Spinal Cord Injury

NCT ID: NCT01086930

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

ReJoyce Workstation

Intervention Type: 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.

Standard Care

Intervention Type: OTHER

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

Standard Care Group

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).

Group Type: OTHER

Standard Care

Intervention Type: OTHER

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

Interventions

ReJoyce Workstation

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 Type: DEVICE

Standard Care

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Austin Hospital, Melbourne Australia

OTHER

Sponsor Role: collaborator

Hampstead Rehabilitation Centre Adelaide

UNKNOWN

Sponsor Role: collaborator

Shenton Park Rehabilitation Centre Perth

UNKNOWN

Sponsor Role: collaborator

Princess Alexandra Hospital, Brisbane, Australia

OTHER

Sponsor Role: collaborator

Royal Rehabilitation Centre Sydney

UNKNOWN

Sponsor Role: collaborator

Prince of Wales Hospital, Sydney

OTHER_GOV

Sponsor Role: collaborator

Burwood Hospital, Christchurch, New Zealand

OTHER

Sponsor Role: collaborator

University of Melbourne

OTHER

Sponsor Role: lead

Responsible Party

Mary Galea

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Harvey

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Mary Galea

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Sarah Dunlop

Role: PRINCIPAL_INVESTIGATOR

The University of Western Australia

Locations

Spinal Unit, Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal Rehabilitation Centre Sydney

Sydney, New South Wales, Australia

Queensland Spinal Cord Injury Service, Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre

Northfield, South Australia, Australia

Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre

Kew, Victoria, Australia

Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital

Shenton Park, Western Australia, Australia

Burwood Academy

Christchurch, , New Zealand

Countries

Australia; New Zealand

References

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.

Reference Type: BACKGROUND

PMID: 21235821 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27008910 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28970100 (View on PubMed)

Other Identifiers

SCIPA Hands-On

Identifier Type: -

Identifier Source: org_study_id