SCIPA (Spinal Cord Injury and Physical Activity) Hands-On: Early Intensive Hand Rehabilitation After Spinal Cord Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 7
- 主要终点
- Modified Action Research Arm Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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
干预措施: ReJoyce Workstation (Device)
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
干预措施: Standard Care (Other)
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).
干预措施: Standard Care (Other)
结局指标
主要结局
Modified Action Research Arm Test
时间窗: 8 weeks and 26 weeks
A standardized measure of unilateral hand and upper limb function
次要结局
- Self-care subscale of the Spinal Cord Independence Measure(8 weeks and 24 weeks)
- Summed Upper Limb Strength of the Graded and Redefined Assessment of Strength Sensibility and Prehension(8 weeks and 26 weeks)
- Capabilities of Upper Extremity(8 weeks and 26 weeks)
- Assessment of Quality of Life (AQoL)(8 weeks and 26 weeks)
- Goal Attainment Scale(8 weeks)
- Participant Perception of Treatment Effectiveness(8 weeks)
- Sensory Score on ISNCSCI(8 weeks and 26 weeks)
- Health Utilities Index Mark 3(8 weeks and 24 weeks)
- AsTex Sensory Test(8 weeks and 26 weeks)
- AuSpinal Test(8 weeks and 26 weeks)
研究者
Mary Galea
Professor
University of Melbourne