Integrating AI in Postural Rehabilitation for Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Atypical parkinsonian syndromes
History of spinal surgery
Previous vertebral trauma
Current or past spinal tumors or infections
Trial design
Design model
Single group
Treatments tested in this trial
Neurorehabilitation
Procedure/Surgery4-8 weeks of inhospital Neurorehabilitation
AI-based home rehabilitation for postural disorders
DeviceAI-based home rehabilitation for postural disorders by means of the Kemtai platform.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: PD-SubjectsExperimental treatment 2 interventions
Trial outcomes
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)
Time frame
Single evaluation after 6-8 weeks from intervention (T1)Secondary outcomes
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).
Time frame
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).
Time frame
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)
Time frame
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)
Time frame
Evaluation at baseline, 6-8 weeks from baseline (T1) and 4 weeks from T1 (T2)Sponsors and contacts
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Source ClinicalTrials.gov