Proprioceptive Exercise in Parkinson's Disease

NCT07681609 | Active Not Recruiting

• 1 other identifier: PerceptiveRehab
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Proprioceptive Training; Physiotherapy

Keywords

sensorised surface; proprioceptive training

Outcome Measures

Primary Outcomes (1)

• Change from baseline in postural stability measured by stabilometric assessment

  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

Secondary Outcomes (3)

• 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)

Other Outcomes (1)

• Numerical Rating Scale for back pain

  Day 0 (baseline) and Day 28 (end of treatment)

Study Arms (2)

Proprioceptive rehabilitation

EXPERIMENTAL

Proprioceptive rehabilitation with sensorised surface

Device: Proprioceptive treaning

physiotherapy

ACTIVE COMPARATOR

Conventional physiotherapy

Behavioral: Physiotherapy

Interventions

Proprioceptive treaning DEVICE

Proprioceptive training carried out using a sensorised surface

Proprioceptive rehabilitation

Physiotherapy BEHAVIORAL

conventional physiotherapy exercises

physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

IRCCS Fondazione Santa Lucia

Roma, 00179, Italy

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Giovanni Morone, PhD, Associate Professor

  IRRCS Santa Lucia foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: May 31, 2021
• Primary Completion: April 1, 2025
• Study Completion (Estimated): April 15, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)