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.
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
- Conditions the study is for
- Parkinson Disease, Physical Inactivity, Physical Disability
- What is being tested?
- Neurorehabilitation and AI-based home rehabilitation for postural disorders
- Type of treatment
- Medical device, Surgery or procedure
- 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
- Recruiting
IRCCS Mondino Foundation
Pavullo nel Frignano, Pavia, 27100
Roberto De Icco, +390382380479, roberto.deicco@mondino.it
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 group | Role | What they receive |
|---|---|---|
| PD-Subjects | Experimental | Subjects 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.
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted8 Jun 2025
- Study start1 Oct 2024
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Martinis, Principal investigator, IRCCS Mondino Foundation
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 7798998Fasano 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 29759930Doherty 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Integrating Artificial Intelligence Solutions in Rehabilitation in Postural Trunk Disorders in Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT07010328
- Acronym / sponsor ID
- PD_PISA_AI
- Keywords
- Physical activity, Neurological disorder, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-Subjects | Experimental | Procedure: Neurorehabilitation, Device: AI-based home rehabilitation for postural disordersSubjects with Parkinson's Disease and postural disorders (Pisa syndrome or camptocormia). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Atypical parkinsonian syndromes
- History of spinal surgery
- Previous vertebral trauma
- Current or past spinal tumors or infections
- Idiopathic scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurorehabilitation4-8 weeks of inhospital Neurorehabilitation | Procedure or surgery | PD-Subjects |
| AI-based home rehabilitation for postural disordersAI-based home rehabilitation for postural disorders by means of the Kemtai platform. | Device | PD-Subjects |
Primary outcome
System Usability Scale (SUS)
Time frame: Single evaluation after 6-8 weeks from intervention (T1)
System Usability Scale (SUS) (continuous variable, score ranging from 0 to 100, with higher scores indicating better perceived usability of the system)
8 secondary outcomes
Static trunk cinematic analysis of movement
Time frame: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)
Dynamic trunk cinematic analysis of movement
Time frame: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)
Time Up and Go test
Time frame: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)
Inertial Gait Analysis
Time frame: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)
30 second chair stand test
Time frame: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)
2 minutes walking test
Time frame: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)
Functional Independence Measure
Time frame: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)
Visual Analogue Scale
Time frame: Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Background: PubMed 7798998Hoshiyama 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.
- Background: PubMed 29759930Fasano 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.
- Background: PubMed 21514890Doherty 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.
- Individual participant dataSharing planned: Yes. The final anonymized database will be uploaded in the Zenodo platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca Martinis principal investigator
IRCCS Mondino Foundation
1 site in 1 country: see every site and its status.
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.