Early Intensive Hand Rehabilitation After Spinal Cord Injury

Spinal Cord Injury Clinical Trial

— SCIPAHandsOn  

Official title:

SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086930
• Other study ID #: SCIPA Hands-On
• Status: Completed
• Phase: Phase 3
• Start date: September 2009
• Est. completion date: September 2015

Study information

• Verified date: April 2021
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Australia	Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre	Kew	Victoria
Australia	South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre	Northfield	South Australia
Australia	Spinal Unit, Prince of Wales Hospital	Randwick	New South Wales
Australia	Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital	Shenton Park	Western Australia
Australia	Royal Rehabilitation Centre Sydney	Sydney	New South Wales
Australia	Queensland Spinal Cord Injury Service, Princess Alexandra Hospital	Woolloongabba	Queensland
New Zealand	Burwood Academy	Christchurch

Sponsors (8)

Lead Sponsor	Collaborator
University of Melbourne	Austin Hospital, Melbourne Australia, Burwood Hospital, Christchurch, New Zealand, Hampstead Rehabilitation Centre Adelaide, Prince of Wales Hospital, Sydney, Princess Alexandra Hospital, Brisbane, Australia, Royal Rehabilitation Centre Sydney, Shenton Park Rehabilitation Centre Perth

Countries where clinical trial is conducted

Australia,  New Zealand, 

References & Publications (2)

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 c — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Action Research Arm Test	A standardized measure of unilateral hand and upper limb function	8 weeks and 26 weeks
Secondary	Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension	Summed strength score of 10 upper limb muscles	8 weeks and 26 weeks
Secondary	Sensory Score on ISNCSCI	Scores for light touch and pinprick tested in dermatomes of the upper limb	8 weeks and 26 weeks
Secondary	AsTex Sensory Test	A measure of texture discrimination in the fingertips	8 weeks and 26 weeks
Secondary	AuSpinal Test	A test of hand function	8 weeks and 26 weeks
Secondary	Capabilities of Upper Extremity	A questionnaire about upper limb function	8 weeks and 26 weeks
Secondary	Assessment of Quality of Life (AQoL)	A questionnaire to assess quality of life	8 weeks and 26 weeks
Secondary	Health Utilities Index Mark 3	A questionnaire to assess quality of life, but includes a domain on hand function	8 weeks and 24 weeks
Secondary	Self-care subscale of the Spinal Cord Independence Measure	A questionnaire about independence in self-care	8 weeks and 24 weeks
Secondary	Goal Attainment Scale	An assessment of whether a participant achieved pre-set goals	8 weeks
Secondary	Participant Perception of Treatment Effectiveness	Self resport of treatment effectiveness	8 weeks