Feasibility and Effectiveness of a Sensorized Bed for Proprioceptive Rehabilitation in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from baseline in postural stability measured by stabilometric assessment
研究概览
简要总结
Parkinson's disease is frequently associated with impaired postural control, balance deficits, trunk misalignment, altered proprioception, and an increased risk of falls. These impairments may contribute to reduced mobility, pain, loss of independence, and decreased quality of life. Although rehabilitation is a key component of Parkinson's disease management, conventional approaches often focus primarily on motor training, while sensory and proprioceptive aspects of postural control may receive less specific attention.
The aim of this randomized controlled longitudinal study is to evaluate the feasibility and preliminary efficacy of SuPerSense, a CE-marked sensorized proprioceptive rehabilitation table, in individuals with Parkinson's disease. SuPerSense is designed to detect pressure distribution on multiple contact points placed under the participant's back while lying on the device. The system provides quantitative information about trunk loading and symmetry, allowing the therapist to guide the patient during proprioceptive exercises and to provide visual feedback and positive reinforcement during training.
Participants with clinically diagnosed Parkinson's disease and postural or motor deficits will be randomized to either an experimental group or a control group. Both groups will receive the same amount of standard neuromotor rehabilitation. In addition, the experimental group will receive SuPerSense-based proprioceptive trunk rehabilitation three times per week for four weeks, for a total of 12 sessions. Each session will last approximately 30 minutes and will include periods of supine positioning with knees extended or flexed, followed by active proprioceptive exercises focused on perceiving back-contact information and improving symmetry of trunk loading. The control group will receive conventional rehabilitation for posture and balance with the same frequency and duration.
Assessments will be performed before and after the one-month rehabilitation period. Outcome measures will include objective postural and gait parameters collected using a baropodometric and stabilometric platform and an inertial gait analysis system. Clinical measures will include balance and gait scales, such as the Tinetti Balance and Gait assessments, the Berg Balance Scale, and a numerical rating scale for back pain. Participants will also undergo an assessment session with the SuPerSense device before and after treatment, in order to compare device-derived measures with standard instrumental and clinical outcomes.
The study is expected to provide information on the feasibility of sensorized proprioceptive trunk rehabilitation in Parkinson's disease and on the immediate and medium-term effects of the SuPerSense system on posture, balance, gait function, and pain. The results may support the integration of quantitative sensory-proprioceptive feedback into rehabilitation programs for individuals with Parkinson's disease.
详细描述
Parkinson's disease (PD) is frequently associated with impaired postural control, balance deficits, trunk misalignment, altered proprioception, gait impairment, back pain, and increased risk of falls. These alterations may negatively affect mobility, independence, social participation, and quality of life (QoL). In PD, postural and balance disorders may include increased dorsal kyphosis, trunk flexion, lateral trunk deviation, Pisa syndrome, camptocormia, altered perception of the trunk midline, and impaired sensory-motor integration. Since balance control depends on the integration of sensory, proprioceptive, vestibular, and visual information, rehabilitation approaches targeting proprioceptive awareness and trunk symmetry may represent a useful complement to conventional neuromotor rehabilitation.
The aim of this randomized controlled trial (RCT) longitudinal study is to evaluate the feasibility and preliminary efficacy of SuPerSense (SPS), a Conformité Européenne (CE)-marked sensorized proprioceptive rehabilitation table, in individuals with PD. SPS is an electromedical device designed to detect the distribution of pressure exerted by the participant's back on multiple contact points. The device consists of a motorized support surface equipped with removable latex cones and sensorized areas connected to a software interface. The system provides quantitative information about trunk loading and pressure distribution, allowing the therapist to monitor the execution of the exercise, guide the participant, and provide feedback during proprioceptive rehabilitation.
A total of 24 participants with clinically diagnosed PD and postural or motor deficits will be enrolled and randomized to one of two groups: an experimental group (EG) receiving SuPerSense-based proprioceptive rehabilitation (SPS-PR) in addition to standard neuromotor rehabilitation, and a control group (CG) receiving conventional rehabilitation focused on posture and balance. Each group will include 12 participants.
The total expected duration of the study is 36 months from ethics committee approval. For each participant with PD, participation will last approximately one month. The study will be conducted at the Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione Santa Lucia, Rome, and Policlinico Universitario Campus Bio-Medico.
Participants with PD will be eligible if they are older than 18 years and have a clinical diagnosis of PD with a modified Hoehn and Yahr (H&Y) stage between 1.5 and 3. Exclusion criteria include spinal or upper-limb conditions requiring fixed corrective devices, inability to understand the proposed task, and severe comorbidities, including severe arthrosis of the spine.
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 (Participant)
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
- •Age older than 18 years.
- •Clinical diagnosis of Parkinson's disease.
- •Modified Hoehn and Yahr stage between 1.5 and
- •Presence of postural and/or motor deficits related to Parkinson's disease.
- •Ability to understand and follow the proposed rehabilitation and assessment procedures.
排除标准
- •Spinal or upper-limb conditions requiring the use of fixed corrective devices.
- •Inability to understand the proposed task or to follow study procedures.
- •Severe comorbidities that may interfere with participation in the rehabilitation program or outcome assessment.
- •Severe spinal arthrosis or other severe musculoskeletal conditions affecting the spine.
研究组 & 干预措施
Proprioceptive rehabilitation
Proprioceptive rehabilitation with sensorised surface
干预措施: Proprioceptive treaning (Device)
physiotherapy
Conventional physiotherapy
干预措施: Physiotherapy (Behavioral)
结局指标
主要结局
Change from baseline in postural stability measured by stabilometric assessment
时间窗: Baseline (Day 0) and after 4 weeks (Day 28) of rehabilitation
Postural stability will be assessed using the FreeMed stabilometric platform. Stabilometric parameters such as the centre of pressure (CoP) trajectory measured in centimeters, will be collected during standing assessment to quantify changes in static postural control after the rehabilitation program.
次要结局
- Change from baseline in gait speed measured by G-Walk(Baseline (Day 0) and after 4 weeks of rehabilitation (Day 28).)
- Change from baseline in Berg Balance Scale score(From baseline (Day 0) up to four weeks of treatment (Day 28))
- Change from baseline in Tinetti Balance score(Day 0 (baseline) and Day 28 (end of treatment))