The Feasibility of Virtual Reality-Based Activities for Upper Limb Rehabilitation of People With Acute/Sub-Acute Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of VR Sessions Completed
研究概览
简要总结
This study aims to test if the VR games could be a form of upper limb rehabilitation for people with arm/hand problems due to SCI while they are in hospital. Participants who have had a spinal cord injury and have tetraplegia will be recruited from the Queen Elizabeth National Spinal Injuries Unit. After they have provided informed consent, they will receive 12 weeks of either standard upper limb therapy ('control group'), or both the VR activities and standard treatment ('VR Group'). Participants who receive VR activities will engage in immersive VR games that have been designed in co-production with people with tetraplegia and spinal cord injury specialists. The games aim to help participants improve the use of their arms and hands while they are undergoing primary rehabilitation within the Queen Elizabeth National Spinal Injuries Unit (QENSIU). The participants who are in the control group will receive their usual rehabilitation and will be given the opportunity to try the VR games after the completion of their involvement in the trial.
This study will measure the feasibility (the 'primary outcome') and explore the effectiveness (the 'secondary outcome') of the VR intervention. Feasibility will be measured by recording how often the VR games are used and whether or not participants use the games for the full duration of the trial. Participants and therapists will be interviewed at the end of the trial.
详细描述
A spinal cord injury (SCI) impacts nearly every aspect of a person's life. People with SCI will have muscular paralysis and loss of sensory and autonomic function below the level of their injury. Immediately following injury, people with SCI require acute in-patient care, during which rehabilitation is started. Following an SCI, people are at risk of pressure ulcers, urinary tract infections, spasticity, autonomic dysreflexia, depression, neuropathic pain, difficulty breathing, and circulatory problems. The multitude of impairments following SCI are associated with lower quality of life.
Reducing reliance on care and achieving higher levels of independence is a major goal for people with SCI. People with SCI can improve the motor power and therefore function of their paralysed limbs through rehabilitation. This enables people with SCI to carry out tasks which would otherwise require a carer. Dressing, bladder and bowel care, transferring in and out of a wheelchair, and feeding are activities that often require more assistance. The difficulty in carrying out these activities can be greatly reduced if people with SCI can recover function in the upper limbs. Even small improvements in limb function can have large effects on a people with SCI's independence.
For people with tetraplegia, where the injury affects all four limbs, improving upper limb function is a major focus of rehabilitation. People with tetraplegia reported improvement in hand and arm function as their highest priority for improvement compared to other rehabilitation targets. Improvements in upper limb function can be achieved through Activity-Based Therapy (ABT). ABT refers to any intervention that involves high intensity, repetitive exercises which target activity-dependent plasticity in spinal circuits. The improvements from ABT in upper limb function have greater effects on quality of life when compared to traditional physical interventions targeted above the level of injury. Exercise can alleviate symptoms of some secondary conditions which can positively impact on quality of life. Physical inactivity is often reported by spinal cord injured people, with limited access to exercise being just one of many barriers to active lifestyles. There is a clear need to improve the accessibility of therapy for people with SCI.
Virtual Reality (VR) technology used as an assistive device for upper limb rehabilitation has good potential for people with SCI during rehabilitation by facilitating greater adherence to therapy and increasing access to the most effective rehabilitation strategies for people with neurological disorders. However, currently only a few studies have investigated the use of VR in SCI rehabilitation of the upper limbs. Of these studies, most have reported positive outcomes.
Three systematic reviews on the use of VR after spinal cord injury have been published in the last few years. Overall the findings suggest that VR training can improve motor function and balance, reduce symptoms such as pain, and improve aerobic function. However, there were consistent limitations reported including a relatively small number of studies, small experimental samples, and no consensus on the optimal treatment parameters or technology employed. Furthermore, there were no studies that evaluated the use of VR in the acute phase following SCI when there is most potential for recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Willing and able to give informed consent for participation in the trial.
- •Aged 18 years or above.
- •An in-patient at the Queen Elizabeth National Spinal Injuries Unit in Glasgow with a diagnosis of tetraplegia.
- •Sustained a cervical spine injury (C4-C8).
- •Medically stable to engage in physical rehabilitation and physical activity.
- •Sitting up in a wheelchair for at least 2 hours daily.
排除标准
- •Scheduled elective surgery or other procedures requiring general anaesthesia anticipated within the next 12 weeks.
- •Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- •Participated in another research trial involving an investigational product in the past 12 weeks.
- •Participating in another research trial investigating upper limb rehabilitation interventions.
- •Self-reported motion sickness.
结局指标
主要结局
Number of VR Sessions Completed
时间窗: Measured over 12 weeks of participation.
The number of sessions of VR the participant completes. This will be recorded as an integer value from 0 to 3 per week of participation.
Semi-structured Interviews
时间窗: Completed at week 12 after the last VR session has been completed.
Determine the usability of the intervention through semi-structured interviews with participants and therapists. Monitoring and reporting of any adverse events, either during or immediately following the VR intervention will be combined with results from semi-structured interviews and questionnaires to determine acceptability and usability.
Target Movement (Treatment Parameters)
时间窗: Completed at week 12 after the last VR session has been completed.
The participant's choice of the type of movement they want to practise will be recorded per session. Movements will include wrist pronation/supination, elbow flexion/extension, and an integrated movement incorporating shoulder movement and elbow flexion and extension. Recording the treatment parameters the participant using VR selects during therapy to determine usability in combination with the interviews and questionnaires.
Time spent in VR
时间窗: Measured over 12 weeks of participation.
The time spent using the VR games, as recorded by the device. This will be measured in minutes and seconds.
Number of completed assessments
时间窗: Measured over 12 weeks of participation.
Completion of the assessments used at baseline, midpoint, and endpoint of the study.
Participant recruitment rate per month
时间窗: Measured over 12 weeks of participation.
The number of participants recruited to the study per month will be combined with eligibility and retention to determine overall recruitment and retention.
Choice of Game (Treatment Parameters)
时间窗: Completed at week 12 after the last VR session has been completed.
The participant's choice of game will be recorded per session. Recording the treatment parameters the participant using VR selects during therapy to determine usability in combination with the interviews and questionnaires.
Participant retention
时间窗: Measured over 12 weeks of participation.
The number of participants recruited to the study per month will be combined with eligibility and retention to determine overall recruitment and retention.
Adverse event monitoring and reporting
时间窗: Measured over 12 weeks of participation.
Monitoring and reporting of any adverse events, either during or immediately following the VR intervention will be combined with results from semi-structured interviews and questionnaires to determine acceptability and usability.
Usefulness, Satisfaction, and Ease of use Questionnaire (USE Questionnaire)
时间窗: Completed at week 12 after the last VR session has been completed.
Determine the usability of the intervention through questionnaire with participants and therapists (USE Questionnaire (Lund 2001)). This a 30-item survey. The maximum value for the USE Questionnaire is 210, and the minimum is 7. Participants can also respond 'not applicable' to all items. Higher scores mean a better outcome. Individual subscores of the USE Questionnaire can indicate that the system is or is not useful, satisfying, and/or easy to use.
Participant eligibility
时间窗: Measured over 12 weeks of participation.
Number of people approached about the study and the number of people who meet the inclusion and exclusion criteria. The number of participants recruited to the study per month will be combined with eligibility and retention to determine overall recruitment and retention.
Number of Repetitions (Treatment Parameters)
时间窗: Completed at week 12 after the last VR session has been completed.
The number of repetitions of the target movement (see outcome 11) will be recorded per session. Recording the treatment parameters the participant using VR selects during therapy to determine usability in combination with the interviews and questionnaires.
Handedness (Treatment Parameter)
时间窗: Completed at week 12 after the last VR session has been completed.
The participant's choice of left, right, or both arm(s)/hand(s) will be recorded per session. Recording the treatment parameters the participant using VR selects during therapy to determine usability in combination with the interviews and questionnaires.
Input Device choices (Treatment Parameters)
时间窗: Completed at week 12 after the last VR session has been completed.
The participant's choice of input device will be recorded per session. Input devices available will include either the use of tracked hand-held controllers, or the use of an infrared-based 'hand-held controller-free' hand-tracking module. Recording the treatment parameters the participant using VR selects during therapy to determine usability in combination with the interviews and questionnaires.
次要结局
- Motor Score(Measured at baseline, 6 weeks, and 12 weeks.)
- Hand/Upper Limb Function(Measured at baseline, 6 weeks, and 12 weeks.)
- Pain Intensity(Measured at baseline, 6 weeks, and 12 weeks.)
- Sensation(Measured at baseline, 6 weeks, and 12 weeks.)
- Independence(Measured at baseline, 6 weeks, and 12 weeks.)