Recovery of Function Through Cycling Therapy With Virtual Reality Biofeedback in Chronically Spinal Cord-injured People
试验速览
- 阶段
- 不适用
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in International Standards of Neurological Classification for SCI (ISNC-SCI) Motor score.
研究概览
简要总结
The annual incidence of traumatic spinal cord injury (SCI) is estimated at 2,500 (35 per week) in the UK and, due to advances in research and clinical management, the majority now have incomplete injuries, with significant potential for neurological improvement. Discovering ways to provide intensive, but cost-effective SCI rehabilitation is therefore increasingly important.
The iCycle combines functional electrical stimulation (FES) cycling with VR cycle-racing feedback, where winning correlates with voluntary effort, to promote recovery. The aim is to improve walking in people with incomplete injuries, fundamental to independence and quality of life as well as long-term health. More intensive rehabilitative training is associated with better outcomes: the iCycle has the potential to increase intensity of exercise without additional demands on therapists' time and therefore cost.
Following the encouraging results in an initial study; it is now important to find out whether recovery will continue at a similar rate if iCycle training continues beyond 4 weeks. Six volunteers with SCI will be recruited to participate in this 20 week, single-site open feasibility trial. The trial consists of an intervention phase lasting up to 12 weeks (3 iCycle sessions per week), and an 8-week follow-up phase. Outcome measures (ISNC-SCI motor scoring, Trunk Impairment scale, Walking Index for Spinal Cord Injury, 6-minute walk test, Goal Attainment Scale and TMS) will be taken every 4 weeks. The 12-week intervention phase will be separated into three 4-week blocks; at the end of each block participants may decide whether or not they wish to continue training.
详细描述
Recruitment:
Participants will be recruited from London Spinal Cord injuries Centre (LSCIC) at the Royal National Orthopaedic Hospital (RNOH) where the training intervention will be carried out. The study will also be advertised via relevant newsletters, bulletin boards, websites and mailing lists.
For each recruited participant, the study will be conducted for up to 20 weeks in total*. This includes: an intervention phase lasting up to 12 weeks and an 8-week follow-up phase. Outcome measure (OM) assessments will be carried out every 4 weeks (OM1-6) to collect study variables. OM assessments will be conducted by either the researcher or physiotherapist. Each OM assessment session will be broken into two parts, each lasting 2 hours.
* At the end of each 4-week block in the intervention phase, participants will be given the option to continue training for the next 4-week block, or to stop training.
Intervention Phase:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years
- •Incomplete SCI above T12
- •>12 months post injury
- •Respond to FES
- •No deteriorating condition or other co-morbidity that would make participation impractical or unsafe.
- •Marginal walker defined as able to rise from a chair, stand for 10 seconds and walk >10 steps without human help (but may use an aid including parallel bars).
排除标准
- •Cardiac pacemaker
- •Pressure sores/skin problems
- •Unhealed lower limb fractures
- •Pregnancy
- •Active heterotrophic ossification - lower limbs
- •Severe osteoporosis
- •Complex regional pain syndrome
- •Implanted metal work at electrode site (< 3/12)
- •Lower Limb Malignancy
- •T6 and below spinal malignancy
- •Uncontrolled autonomic dysreflexia
- •History of knee dislocation/subluxation
- •Allergy to electrodes
- •Cognitive difficulties - must be able to demonstrate an understanding of the iCycle and the virtual reality cycling game
- •Severe spasticity - Ashworth scale 4 or 5 in any lower limb muscle groups
- •Neurological degenerative diseases
研究组 & 干预措施
iCycle training
Participants will attend 3 training sessions per week at the RNOH. During these sessions, participants will tether their wheelchair (from under the seat) to the front of the iCycle, and their feet will be attached to the iCycle pedals. For training, participants will complete virtual reality cycle races displayed on a large screen in front of the iCycle: the more voluntary effort the participant contributes the greater the speed of the avatar. During cycling, a motor will control cycling speed, and muscle stimulation (FES) will be applied to the leg muscles (right and left gluteus, quadriceps and hamstrings) on alternative revolutions of the pedals. A dashboard screen will display controls for the stimulation, speed, brake, game switch and an emergency stop. Sessions will increase from 20 mins or the maximum achievable at the start (whichever is lower) up to at least 1 hour.
干预措施: iCycle Mark 3 (Device)
结局指标
主要结局
Change in International Standards of Neurological Classification for SCI (ISNC-SCI) Motor score.
时间窗: 15 minutes
This is a is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI.
次要结局
- change in 6-minute walk test (6MWT) distance(15 minutes)
- Change in Walking Index for Spinal Cord Injury (WISCI II) score(15 minutes)
- Change in Trunk Impairment Scale (TIS) score(15 minutes)
- Audio/transcribed feedback from participants from semi-structured interview(30 minutes)
- Threshold of evoked responses to Transcranial Magnetic Stimulation (TMS)(60 minutes)