Enhancing Functional and Cognitive Performances in People With Amputation and Peripheral Neuropathy Through the Restoration of Sensory Feedback in Real World and Virtual Reality Environments
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change between tasks with sensory feedback and with no sensory feedback in Visual Analogue scale for confidence
研究概览
简要总结
Many amputees suffer from Phantom Limb Pain (PLP), a condition where painful perceptions arise from the missing limb. Leg amputees wear prostheses that do not provide any sensory feedback, apart from the stump-socket interaction. Increased physical effort associated with prosthesis use as well as discomfort often lead to rejection of artificial limbs. Additionally, the perception of the missing limb and its brain representation, do not match-up with what amputees see (the prosthesis) and this is made worse by the absence of sensory feedback. Therefore, re-establishing the sensory flow of information between the subject's brain and the prosthetic device is extremely important to avoid this mismatch, which creates inadequate embodiment. This study focuses on improving functional abilities and decreasing PLP in amputees thanks to the use of a system able to generate a sensory feedback (SF), which will be provided with a non-invasive electrical stimulation (ES). First, the possibility of enhancing the performance in different functional tasks thanks to the use of SF will be explored. Furthermore, it will be evaluated if SF enhances the prosthesis embodiment and helps restoring a multisensory integration (visuo-tactile), potentially providing also a pain relief. Once tested this system on amputees, also people with peripheral neuropathy and sensory loss will be recruited. Diabetic patients can suffer from symmetrical polyneuropathy (DSPN), which is a common complication caused by prolonged glucose unbalanced levels that lead to nerve damage. Non-invasive ES has been proposed and used as a therapy to treat the chronic pain conditions. In particular, TENS (transcutaneous electrical nerve stimulation) is a type of non-invasive ES, which is able to activate large diameter afferent fibers. The gate control theory of pain states that these large diameter fibers inhibit central nociceptive transmission with a resultant decrease in pain perception. Therefore, also these patients will be recruited to see whether adding a non-invasive SF can enhance their functional motor abilities while diminishing their pain.
The subjects will perform a pool of the following tasks, depending on their residual abilities: motor tasks (walking on ground level and on stairs), cognitive tasks (dual tasks), subjective evaluation of prosthesis weight and description of sensations from ES.
Some tasks will be performed in Virtual Reality environments with and without an active stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •transfemoral amputation or transtibial amputation or knee disarticulation or diabetic peripheral neuropathy
- •the subject should be healthy other than the amputation and the diabetic neuropathy and in the range of 18-70 years old
- •the subject should be able to comfortably walk, sit and stand alone
排除标准
- •cognitive impairment
- •pregnancy
- •Prior or current psychological diseases such as borderline, schizophrenia, Depression or Maniac Depression
- •acquired brain injury with residual impairment
- •excessive sensitivity or pain to electrical stimulation with surface electrodes
- •cybersickness
研究组 & 干预措施
experimental group
amputees or diabetics receiving intervention
干预措施: Sensory Feedback (Device)
结局指标
主要结局
Change between tasks with sensory feedback and with no sensory feedback in Visual Analogue scale for confidence
时间窗: immediately after sessions up to three weeks
Subjects will complete VAS scale to measure confidence level (from 0 to 10, where 10 is max confidence)
Change between tasks with sensory feedback and with no sensory feedback in Centre of Mass and Pressure
时间窗: during motor tasks up to 3 weeks
CoM and CoP will be assessed during motor perfomances of the subjects
Change between tasks with sensory feedback and with no sensory feedback in Joint torque
时间窗: during motor tasks up to three weeks
kinematic measurement
Change in Telescoping measures between different conditions
时间窗: Immediately after sessions in Virtual Reality up to three weeks
To measure embodiment subjects will be asked after VR sessions to indicate how long they feel their leg without looking at the limb in real world. This is a measure of embodiment.
Change from baseline in Visual Analogue scale for pain throughout the study
时间窗: one month before the study, 2 weeks before the study, immediately before the intervention, immediately after the intervento, after tasks with and without sensory feedback, 2 weeks after last intervention, 1 month after last intervention
Subjects will complete VAS scale to measure pain level (from 0 to 10, 10 is worst pain immaginable)
Change between tasks with sensory feedback and with no sensory feedback in Ground Reaction Forces
时间窗: during motor tasks up to 3 weeks
GRF will be assessed during motor perfomances of the subjects
Change from baseline and between tasks with sensory feedback and with no sensory feedback in Vo2 consumption
时间窗: during motor tasks up to 3 weeks
metabolic consumption is going to be measured with mobile spiroergometry and compared after walking with and without sensory feedback
Change from baseline between tasks with sensory feedback and with no sensory feedback in Embodiment
时间窗: immediately after sessions up to 3 weeks
Embodiment will be measured with questionnaires (from -3 to +3, +3 totally agrees; two questions are from 1 to 10 (to measure vividness, where 10 is max vividness) and from 1 to 100 (to measure prevalence, where 100 is max duration of the embodiment feeling))
Change in Proprioceptive drift between different conditions
时间窗: Immediately after sessions in Virtual Reality up to three weeks
To measure embodiment subjects will be asked after VR sessions to indicate where they feel their leg without looking at the limb in real world. This is a measure of embodiment.
次要结局
- Amputee Mobility Predictor(Immediately before the intervention)
- Trinity Amputation and Prosthesis Experiences Scales(Immediately before intervention)
- Change in Quality of Life in Neurological Disorders(one week before first session and one week after last session)
研究者
Greta Preatoni
Doctoral fellowship
ETH Zurich