Back to resultsEarly Intensive Hand Rehabilitation After Spinal Cord Injury (SCIPAHandsOn)
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ReJoyce Workstation
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Sites / Locations
- Spinal Unit, Prince of Wales Hospital
- Royal Rehabilitation Centre Sydney
- Queensland Spinal Cord Injury Service, Princess Alexandra Hospital
- South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre
- Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre
- Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital
- Burwood Academy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention Group
Standard Care Group
Arm 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
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).
Outcomes
Primary Outcome Measures
Modified Action Research Arm Test
A standardized measure of unilateral hand and upper limb function
Secondary Outcome Measures
Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension
Summed strength score of 10 upper limb muscles
Sensory Score on ISNCSCI
Scores for light touch and pinprick tested in dermatomes of the upper limb
AsTex Sensory Test
A measure of texture discrimination in the fingertips
AuSpinal Test
A test of hand function
Capabilities of Upper Extremity
A questionnaire about upper limb function
Assessment of Quality of Life (AQoL)
A questionnaire to assess quality of life
Health Utilities Index Mark 3
A questionnaire to assess quality of life, but includes a domain on hand function
Self-care subscale of the Spinal Cord Independence Measure
A questionnaire about independence in self-care
Goal Attainment Scale
An assessment of whether a participant achieved pre-set goals
Participant Perception of Treatment Effectiveness
Self resport of treatment effectiveness
Full Information
NCT ID
NCT01086930
First Posted
March 12, 2010
Last Updated
April 28, 2021
Sponsor
University of Melbourne
Collaborators
Austin Hospital, Melbourne Australia, Hampstead Rehabilitation Centre Adelaide, Shenton Park Rehabilitation Centre Perth, Princess Alexandra Hospital, Brisbane, Australia, Royal Rehabilitation Centre Sydney, Prince of Wales Hospital, Sydney, Burwood Hospital, Christchurch, New Zealand
1. Study Identification
Unique Protocol Identification Number
NCT01086930
Brief Title
Early Intensive Hand Rehabilitation After Spinal Cord Injury
Acronym
SCIPAHandsOn
Official Title
SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne
Collaborators
Austin Hospital, Melbourne Australia, Hampstead Rehabilitation Centre Adelaide, Shenton Park Rehabilitation Centre Perth, Princess Alexandra Hospital, Brisbane, Australia, Royal Rehabilitation Centre Sydney, Prince of Wales Hospital, Sydney, Burwood Hospital, Christchurch, New Zealand
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm 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
Arm Title
Standard Care Group
Arm Type
Other
Arm 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).
Intervention Type
Device
Intervention Name(s)
ReJoyce Workstation
Intervention Description
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
Other
Intervention Name(s)
Standard Care
Intervention Description
All participants will continue to receive the same standard care for the hand and upper limb as typically provided by their rehabilitation units.
Primary Outcome Measure Information:
Title
Modified Action Research Arm Test
Description
A standardized measure of unilateral hand and upper limb function
Time Frame
8 weeks and 26 weeks
Secondary Outcome Measure Information:
Title
Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension
Description
Summed strength score of 10 upper limb muscles
Time Frame
8 weeks and 26 weeks
Title
Sensory Score on ISNCSCI
Description
Scores for light touch and pinprick tested in dermatomes of the upper limb
Time Frame
8 weeks and 26 weeks
Title
AsTex Sensory Test
Description
A measure of texture discrimination in the fingertips
Time Frame
8 weeks and 26 weeks
Title
AuSpinal Test
Description
A test of hand function
Time Frame
8 weeks and 26 weeks
Title
Capabilities of Upper Extremity
Description
A questionnaire about upper limb function
Time Frame
8 weeks and 26 weeks
Title
Assessment of Quality of Life (AQoL)
Description
A questionnaire to assess quality of life
Time Frame
8 weeks and 26 weeks
Title
Health Utilities Index Mark 3
Description
A questionnaire to assess quality of life, but includes a domain on hand function
Time Frame
8 weeks and 24 weeks
Title
Self-care subscale of the Spinal Cord Independence Measure
Description
A questionnaire about independence in self-care
Time Frame
8 weeks and 24 weeks
Title
Goal Attainment Scale
Description
An assessment of whether a participant achieved pre-set goals
Time Frame
8 weeks
Title
Participant Perception of Treatment Effectiveness
Description
Self resport of treatment effectiveness
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Harvey
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mary Galea
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Dunlop
Organizational Affiliation
The University of Western Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spinal Unit, Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
Royal Rehabilitation Centre Sydney
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Queensland Spinal Cord Injury Service, Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
South Australian Spinal Cord Injury Service, Hampstead Rehabilitation Centre
City
Northfield
State/Province
South Australia
Country
Australia
Facility Name
Victorian Spinal Cord Injury Service, Royal Talbot Rehabilitation Centre
City
Kew
State/Province
Victoria
ZIP/Postal Code
3101
Country
Australia
Facility Name
Sir George Bebrook Spinal Injuries Centre, Royal Perth Hospital
City
Shenton Park
State/Province
Western Australia
Country
Australia
Facility Name
Burwood Academy
City
Christchurch
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will only be provided in aggregate. No individual data will be released, as per the ethics approval.
Citations:
PubMed Identifier
21235821
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.
Results Reference
background
PubMed Identifier
27008910
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.
Results Reference
result
PubMed Identifier
28970100
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.
Results Reference
derived
Learn more about this trial
Early Intensive Hand Rehabilitation After Spinal Cord Injury
We'll reach out to this number within 24 hrs