- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07681609
Proprioceptive Exercise in Parkinson's Disease
Feasibility and Effectiveness of a Sensorized Bed for Proprioceptive Rehabilitation in Patients With Parkinson's Disease
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.
연구 개요
상세 설명
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.
Both PD groups will receive the same overall amount of neuromotor rehabilitation, consisting of approximately three hours per day of rehabilitation. Within this rehabilitation program, the EG will receive 12 sessions of treatment with the SPS device, delivered three times per week for four weeks. Each SPS session will last approximately 30 minutes. During the session, the participant will lie on the device and will perform proprioceptive trunk exercises. The session will include one minute in supine position with knees extended, one minute with knees flexed, and two active treatment phases lasting approximately 10 minutes each. During the active phases, the participant will be asked to focus on the sensations arising from the contact points on the back and to improve symmetry of trunk loading. Rest periods and additional positioning phases with knees flexed and extended will be included between and after the active treatment phases. The therapist will use the quantitative information provided by the device to guide the participant and support correct task execution.
The CG will receive CR aimed at improving posture and balance, with the same frequency and duration as the SPS-PR intervention. Blinding of participants to group allocation is not feasible because of the nature of the intervention. Instrumental assessments will be performed using computerized devices to obtain objective and reproducible measures.
All participants with PD will be evaluated before and after the one-month rehabilitation period. Instrumental assessments will include gait analysis using the G-Walk inertial measurement unit (IMU) sensor system and postural assessment using the FreeMed baropodometric and stabilometric platform. The FreeMed platform will be used to collect static baropodometric measures, dynamic baropodometric measures, and stabilometric parameters. G-Walk will be used to assess accelerometer-based gait parameters. Clinical assessments will include the Tinetti Balance Scale (TBS), the Tinetti Gait Scale (TGS), the Berg Balance Scale (BBS), and a Numerical Rating Scale (NRS) for back pain.
Participants with PD will also undergo an SPS assessment session before and after the rehabilitation period. Data extracted from the SPS device will be compared with data obtained from the baropodometric/stabilometric platform, the IMU-based gait analysis system, and clinical scales. This will allow exploration of the validity of device-derived measures and their sensitivity to changes following rehabilitation.
The primary objective of the study is to assess the feasibility of a sensorized proprioceptive trunk rehabilitation program using SPS in individuals with PD. Secondary objectives are to evaluate the immediate and medium-term effects of SPS-PR on postural stability, gait function, trunk symmetry, balance, and back pain. The study will also explore whether quantitative pressure-distribution measures obtained from the SPS device can provide clinically meaningful information for monitoring proprioceptive rehabilitation in PD.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Roma, 이탈리아, 00179
- IRCCS Fondazione Santa Lucia
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age older than 18 years.
- Clinical diagnosis of Parkinson's disease.
- Modified Hoehn and Yahr stage between 1.5 and 3.
- Presence of postural and/or motor deficits related to Parkinson's disease.
- Ability to understand and follow the proposed rehabilitation and assessment procedures.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Proprioceptive rehabilitation
Proprioceptive rehabilitation with sensorised surface
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Proprioceptive training carried out using a sensorised surface
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활성 비교기: physiotherapy
Conventional physiotherapy
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conventional physiotherapy exercises
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in postural stability measured by stabilometric assessment
기간: Baseline (Day 0) and after 4 weeks (Day 28) of rehabilitation
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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.
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Baseline (Day 0) and after 4 weeks (Day 28) of rehabilitation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in gait speed measured by G-Walk
기간: Baseline (Day 0) and after 4 weeks of rehabilitation (Day 28).
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Gait speed ( expressed in meter/seconds) will be measured using the G-Walk inertial sensor system during walking assessment.
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Baseline (Day 0) and after 4 weeks of rehabilitation (Day 28).
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Change from baseline in Berg Balance Scale score
기간: From baseline (Day 0) up to four weeks of treatment (Day 28)
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Balance performance will be assessed using the Berg Balance Scale (BBS).
The scale includes 14 functional balance tasks, each scored from 0 to 4. A score of 0 indicates inability to perform the task, whereas a score of 4 indicates independent and safe performance.
The total score ranges from 0 to 56, with higher scores indicating better balance performance.
The change in total score from baseline to the end of the rehabilitation program will be used to evaluate clinical changes in balance.
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From baseline (Day 0) up to four weeks of treatment (Day 28)
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Change from baseline in Tinetti Balance score
기간: Day 0 (baseline) and Day 28 (end of treatment)
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Balance will be assessed using the balance section of the Tinetti Performance-Oriented Mobility Assessment (POMA).
The balance section ranges from 0 to 16, with higher scores indicating better balance performance and lower fall risk.
An increase in the score indicates improvement.
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Day 0 (baseline) and Day 28 (end of treatment)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Numerical Rating Scale for back pain
기간: Day 0 (baseline) and Day 28 (end of treatment)
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Back pain intensity will be assessed using a Numerical Rating Scale (NRS).
The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Lower scores indicate lower pain intensity.
A decrease in the score indicates improvement.
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Day 0 (baseline) and Day 28 (end of treatment)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Giovanni Morone, PhD, Associate Professor, IRRCS Santa Lucia foundation
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PerceptiveRehab
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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