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.

Study Overview

• Status: Active, not recruiting
• Conditions: Physiotherapy; Proprioceptive Training
• Intervention / Treatment: Device: Proprioceptive treaning; Behavioral: Physiotherapy

Detailed Description

Parkinson's disease 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. In Parkinson's disease, 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 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 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 Parkinson's disease and postural or motor deficits will be enrolled and randomized to one of two groups: an experimental group receiving SuPerSense-based proprioceptive rehabilitation in addition to standard neuromotor rehabilitation, and a control group 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 Parkinson's disease, participation will last approximately one month. The study will be conducted at IRCCS Fondazione Santa Lucia, Rome, and Policlinico Universitario Campus Bio-Medico.

Participants with Parkinson's disease will be eligible if they are older than 18 years and have a clinical diagnosis of Parkinson's disease with a modified Hoehn and Yahr 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 Parkinson's disease groups will receive the same overall amount of neuromotor rehabilitation, consisting of approximately three hours per day of rehabilitation. Within this rehabilitation program, the experimental group will receive 12 sessions of treatment with the SuPerSense device, delivered three times per week for four weeks. Each SuPerSense 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 control group will receive conventional rehabilitation aimed at improving posture and balance, with the same frequency and duration as the SuPerSense 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 Parkinson's disease will be evaluated before and after the one-month rehabilitation period. Instrumental assessments will include gait analysis using the G-Walk inertial 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, the Tinetti Gait scale, the Berg Balance Scale, and a Numerical Rating Scale for back pain.

Participants with Parkinson's disease will also undergo a SuPerSense assessment session before and after the rehabilitation period. Data extracted from the SuPerSense device will be compared with data obtained from the baropodometric/stabilometric platform, the inertial 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 SuPerSense in individuals with Parkinson's disease. Secondary objectives are to evaluate the immediate and medium-term effects of SuPerSense-based rehabilitation on postural stability, gait function, trunk symmetry, balance, and back pain. The study will also explore whether quantitative pressure-distribution measures obtained from the SuPerSense device can provide clinically meaningful information for monitoring proprioceptive rehabilitation in Parkinson's disease.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00179
    • IRCCS Fondazione Santa Lucia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proprioceptive rehabilitation; Proprioceptive rehabilitation with sensorised surface	Device: Proprioceptive treaning; Proprioceptive training carried out using a sensorised surface
Active Comparator: physiotherapy; Conventional physiotherapy	Behavioral: Physiotherapy; conventional physiotherapy exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in postural stability measured by stabilometric assessment	Postural stability will be assessed using the FreeMed baropodometric and stabilometric platform. Stabilometric parameters 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in gait speed measured by G-Walk	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	Balance performance will be assessed using the Berg Balance Scale. 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	Balance will be assessed using the balance section of the Tinetti Performance-Oriented Mobility Assessment. 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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale for back pain	Back pain intensity will be assessed using a Numerical Rating Scale. 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)

Collaborators and Investigators

• Sponsor: I.R.C.C.S. Fondazione Santa Lucia
• Investigators: Principal Investigator: Giovanni Morone, PhD, Associate Professor, IRRCS Santa Lucia foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Actual): April 1, 2025
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: sensorised surface; proprioceptive training
• Additional Relevant MeSH Terms: Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: PerceptiveRehab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No