Integrating AI in Postural Rehabilitation for Parkinson's Disease

NCT07010328 | Recruiting

• 1 other identifier: PD_PISA_AI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Parkinson Disease; Physical Inactivity; Physical Disability; Pisa Syndrome

Keywords

Physical activity; Neurological disorder; Artificial Intelligence

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (8)

• Static trunk cinematic analysis of movement

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

• Dynamic trunk cinematic analysis of movement

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

• Time Up and Go test

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

• Inertial Gait Analysis

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

• 30 second chair stand test

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

Study Arms (1)

PD-Subjects

EXPERIMENTAL

Subjects with Parkinson's Disease and postural disorders (Pisa syndrome or camptocormia).

Procedure: Neurorehabilitation; Device: AI-based home rehabilitation for postural disorders

Interventions

Neurorehabilitation PROCEDURE

4-8 weeks of inhospital Neurorehabilitation

PD-Subjects

AI-based home rehabilitation for postural disorders DEVICE

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

PD-Subjects

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

IRCCS Mondino Foundation

Pavullo nel Frignano, Pavia, 27100, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 7798998 BACKGROUND

• 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.

  PMID: 29759930 BACKGROUND

• 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.

  PMID: 21514890 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Sedentary Behavior; Motor Activity; Nervous System Diseases

Interventions

Neurological Rehabilitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Luca Martinis

  IRCCS Mondino Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto De Icco

CONTACT

+390382380425; roberto.deicco@mondino.it

Cinzia Fattore

CONTACT

+390382380385; cinzia.fattore@mondino.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 8, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)