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Proprioceptive Exercise in Parkinson's Disease

2 lipca 2026 zaktualizowane przez: I.R.C.C.S. Fondazione Santa Lucia

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

24

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Roma, Włochy, 00179
        • IRCCS Fondazione Santa Lucia

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Proprioceptive rehabilitation
Proprioceptive rehabilitation with sensorised surface
Proprioceptive training carried out using a sensorised surface
Aktywny komparator: physiotherapy
Conventional physiotherapy
conventional physiotherapy exercises

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in postural stability measured by stabilometric assessment
Ramy czasowe: 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.
Baseline (Day 0) and after 4 weeks (Day 28) of rehabilitation

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in gait speed measured by G-Walk
Ramy czasowe: Baseline (Day 0) and after 4 weeks of rehabilitation (Day 28).
Gait speed ( expressed in meter/seconds) will be measured using the G-Walk inertial sensor system during walking assessment.
Baseline (Day 0) and after 4 weeks of rehabilitation (Day 28).
Change from baseline in Berg Balance Scale score
Ramy czasowe: From baseline (Day 0) up to four weeks of treatment (Day 28)
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.
From baseline (Day 0) up to four weeks of treatment (Day 28)
Change from baseline in Tinetti Balance score
Ramy czasowe: Day 0 (baseline) and Day 28 (end of treatment)
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.
Day 0 (baseline) and Day 28 (end of treatment)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Numerical Rating Scale for back pain
Ramy czasowe: Day 0 (baseline) and Day 28 (end of treatment)
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.
Day 0 (baseline) and Day 28 (end of treatment)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Giovanni Morone, PhD, Associate Professor, IRRCS Santa Lucia foundation

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

31 maja 2021

Zakończenie podstawowe (Rzeczywisty)

1 kwietnia 2025

Ukończenie studiów (Szacowany)

15 kwietnia 2027

Daty rejestracji na studia

Pierwszy przesłany

26 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

2 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 lipca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • PerceptiveRehab

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Data will be available under request to corresponding Author after publications

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .