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Parkinson DiseaseNCT07010328

Integrating AI in Postural Rehabilitation for Parkinson's Disease

A study testing Neurorehabilitation and AI-based home rehabilitation for postural disorders in people with Parkinson Disease and Physical Inactivity, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Postural abnormalities are highly disabling complications of Parkinson's disease (PD). These include camptocormia, anterocollis, and Pisa Syndrome (PS). PS is characterized by a lateral trunk flexion (LTF) typically exceeding 10 degrees, often accompanied by axial rotation, asymmetric shoulder positioning, and poor… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Neurorehabilitation and AI-based home rehabilitation for postural disorders
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
1 Oct 2024to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age above 18 years
  • Diagnosis of Parkinson's disease according to MDS criteria
  • Hoehn and Yahr stage ≤ III
  • Clinical diagnosis of camptocormia (presence of an anterior axial trunk flexion of at least 30°), or of Pisa Syndrome (presence of a lateral trunk flexion of at least 10°) at the time of enrollment (T0)
  • Mini-Mental State Examination (MMSE) score > 23

Who cannot join

  • Atypical parkinsonian syndromes
  • History of spinal surgery
  • Previous vertebral trauma
  • Current or past spinal tumors or infections
  • Idiopathic scoliosis
  • Ankylosing spondylitis
Show all 9Show fewer
  • Spinal canal stenosis
  • Other neurological conditions
  • Severe dyskinesias

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • IRCCS Mondino Foundation

    Pavullo nel Frignano, Pavia, 27100

    Roberto De Icco, +390382380479, roberto.deicco@mondino.it

    Recruiting

Other trials in Italy

About this study

Official title: Efficacy of Integrating Artificial Intelligence Solutions in Rehabilitation in Postural Trunk Disorders in Parkinson's Disease.

Postural abnormalities are highly disabling complications of Parkinson's disease (PD). These include camptocormia, anterocollis, and Pisa Syndrome (PS). PS is characterized by a lateral trunk flexion (LTF) typically exceeding 10 degrees, often accompanied by axial rotation, asymmetric shoulder positioning, and poor awareness of the postural alteration. This condition worsens during upright activities and improves in a supine position. Patients with PD and PS are characterized by more pronounced motor asymmetry, a disorganized trunk muscle activity, back pain, balance issues, and reduced quality of life compared to PD patients without postural disorders.

Camptocormia, another disabling postural anomaly, involves an anterior trunk flexion that also improves when lying down. Both PS and camptocormia are challenging to treat, with limited and short-lasting benefits from current multidisciplinary approaches, including medication, physiotherapy, botulinum toxin injections, and transcranial direct current stimulation (tDCS).

Read more

Given the limitations of traditional rehabilitation strategies, there is a growing need for innovative and personalized approaches. In this context, advanced technologies such as artificial intelligence (AI) offer new possibilities for home-based treatment. This study aims to evaluate the feasibility of using a real-time visual feedback system powered by AI as a complementary intervention following inpatient neurorehabilitation for PD patients with trunk postural disorders (PS or camptocormia). A secondary objective is to assess whether an AI-guided, personalized exercise program can help maintain improvements in posture, mobility, and quality of life in the medium term.

By integrating quantitative and qualitative outcomes, this study seeks to fill a gap in the literature and explore the potential of AI-driven home rehabilitation to support long-term functional gains and foster greater independence and well-being in people with PD.

Read the detailed description

Postural abnormalities represent particularly disabling complications of Parkinson's disease (PD), significantly affecting patients' functional independence and quality of life. Among the most commonly observed postural deformities there are camptocormia, anterocollis, and Pisa Syndrome (PS). Pisa Syndrome is clinically characterized by a lateral trunk flexion (LTF) greater than 10 degrees, typically presenting with a uniform inclination from the sacrum to the C7 vertebra. It is often accompanied by axial rotation, leading to elevation and forward displacement of the contralateral shoulder. Additional clinical features include difficulty rotating the trunk away from the leaning side, worsening of symptoms during upright posture or walking, improvement in the supine position, and poor patient awareness of the postural deviation.

Patients with PD and PS exhibit greater motor symptom asymmetry, disorganized paraspinal muscle activation, back pain, balance and postural control issues, and reduced quality of life compared to PD patients without postural abnormalities. The current standard of care for these postural disorders typically includes a multidisciplinary approach involving pharmacological treatment, physical therapy, botulinum toxin injections, and transcranial direct current stimulation (tDCS). However, these interventions frequently yield only modest and short-lived improvements, highlighting the need for more sustainable and accessible treatment strategies.

Camptocormia is another severe postural abnormality seen in PD, defined as an involuntary forward flexion of the trunk that is mostly apparent during standing and walking, and tends to reduce when the patient is supine. Like PS, camptocormia is frequently associated with chronic back pain and is often resistant to dopaminergic medication, with many patients reporting no significant improvement in either "on" or "off" states.

The long-term management of these postural disorders remains a significant clinical challenge. Innovative, individualized rehabilitation strategies that can be seamlessly integrated into patients' daily routines are urgently needed. In recent years, technological advancements-particularly in the field of artificial intelligence (AI)-have opened up new avenues for delivering personalized home-based interventions.

This study investigates the feasibility and potential benefits of using a real-time, AI-based visual feedback system as a complementary treatment following hospital-based neurorehabilitation for PD patients with trunk postural disorders, specifically PS and camptocormia. The intervention uses the Kemtai platform, which analyzes movement through video-based AI to deliver customized exercise routines and real-time corrective feedback. This allows patients to engage in highly interactive and adaptive rehabilitation sessions from home, potentially improving adherence and functional outcomes.

The primary objective of the study is to assess the feasibility, safety, and usability of this AI-based system as a continuation of care after inpatient rehabilitation. The secondary objective is to evaluate whether this personalized exercise program can prolong, over the medium term, the gains in posture, mobility, and quality of life achieved during the structured hospital-based rehabilitation period.

By collecting both qualitative feedback (e.g., user satisfaction, perceived usefulness) and quantitative metrics (e.g., trunk inclination angles, mobility scores by means of cinemtaic analysis of movement), this study aims to contribute new evidence on the role of intelligent digital tools in managing postural abnormalities in PD. The overarching hypothesis is that a home-based, AI-monitored exercise program could offer a sustainable, effective, accessible, and patient-centered approach to maintaining functional gains and supporting greater autonomy in everyday life.

Being tested
Neurorehabilitation, AI-based home rehabilitation for postural disorders
Keywords
Physical activity, Neurological disorder, Artificial Intelligence
Medical subject headings
Parkinson Disease, Sedentary Behavior, Motor Activity, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeurorehabilitationProcedure or surgery

    4-8 weeks of inhospital Neurorehabilitation

  • AI-based home rehabilitation for postural disordersDevice

    AI-based home rehabilitation for postural disorders by means of the Kemtai platform.

Study groups in NCT07010328
Study groupRoleWhat they receive
PD-SubjectsExperimentalSubjects with Parkinson's Disease and postural disorders (Pisa syndrome or camptocormia).
Receives: Procedure: Neurorehabilitation; Device: AI-based home rehabilitation for postural disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. System Usability Scale (SUS)

    System Usability Scale (SUS) (continuous variable, score ranging from 0 to 100, with higher scores indicating better perceived usability of the system)

    Measured: Single evaluation after 6-8 weeks from intervention (T1)

Secondary outcomes (8)
  1. Static trunk cinematic analysis of movement

    By means of a cinematic analysis of movement, we will record trunk posture in static upright standing position (anterior trunk flexion and lateral trunk flexion).

    Measured: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)

  2. Dynamic trunk cinematic analysis of movement

    By means of a cinematic analysis of movement, we will record the range of motion of trunk during four dynamic tasks (anterior flexion, trunk extension, right and left trunk lateral flexion).

    Measured: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)

  3. Time Up and Go test

    Time Up and Go test (continuous variable with units of measurement: second)

    Measured: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)

  4. Inertial Gait Analysis

    Gait analysis performed Inertial Measeurement Units to assess trunk acceleration-derived gait indexes ( continuous variables without measure unit)

    Measured: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)

  5. 30 second chair stand test

    Sit to Stand Test (continuous variable with units of measurement: second)

    Measured: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)

  6. 2 minutes walking test

    2 minutes walking test (continuous variable with units of measurement: meters)

    Measured: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)

  7. Functional Independence Measure

    Functional Independence Measure (FIM) total score (continuous variable, score ranging from 18 to 126, with higher scores indicating greater functional independence)

    Measured: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)

  8. Visual Analogue Scale

    Visual Analogue Scale for pain (continuous variable, score ranging from 0 to 10, with higher scores indicating greater pain intensity)

    Measured: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2025
  2. Study start1 Oct 2024
  3. Primary completionJan 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07010328
Sponsor's protocol ID
PD_PISA_AI
Status last verified
May 2025
First submitted
20 May 2025
Last updated
8 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The final anonymized database will be uploaded in the Zenodo platform.

Publications

  • Hoshiyama M, Kaneoke Y, Koike Y, Takahashi A, Watanabe S. Hypokinesia of associated movement in Parkinson's disease: a symptom in early stages of the disease. J Neurol. 1994 Aug;241(9):517-21. doi: 10.1007/BF00873512.

    PubMed 7798998
  • Fasano A, Geroin C, Berardelli A, Bloem BR, Espay AJ, Hallett M, Lang AE, Tinazzi M. Diagnostic criteria for camptocormia in Parkinson's disease: A consensus-based proposal. Parkinsonism Relat Disord. 2018 Aug;53:53-57. doi: 10.1016/j.parkreldis.2018.04.033. Epub 2018 May 8.

    PubMed 29759930
  • Doherty KM, van de Warrenburg BP, Peralta MC, Silveira-Moriyama L, Azulay JP, Gershanik OS, Bloem BR. Postural deformities in Parkinson's disease. Lancet Neurol. 2011 Jun;10(6):538-49. doi: 10.1016/S1474-4422(11)70067-9. Epub 2011 Apr 22.

    PubMed 21514890

Questions about this trial

What is this clinical trial studying?

A study testing Neurorehabilitation and AI-based home rehabilitation for postural disorders in people with Parkinson Disease and Physical Inactivity, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Roberto De Icco (+390382380425, roberto.deicco@mondino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

System Usability Scale (SUS) (time frame: Single evaluation after 6-8 weeks from intervention (T1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07010328, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.

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