CST+MST Intervention on People Living With Mild-to-moderate Dementia (CST+MST)

Outcome Research Study on the Evaluation of a Combined Treatment of Cognitive Stimulation Therapy and Group Motor Stimulation in People With Mild-to-Moderate Dementia

Non-pharmacological interventions such as Cognitive Stimulation Therapy (CST) and physical activity are recommended for people living with mild-to-moderate dementia. Emerging evidence suggests that combining cognitive and motor interventions may provide synergistic benefits on cognition, mobility, and functional abilities. This study aims to evaluate the effectiveness of a combined CST and Motor Stimulation Treatment (MST) programme.

This multicenter quasi-experimental study will involve 30 clinical centers across five Italian regions. Participants aged ≥65 years with mild-to-moderate dementia will receive 14 combined CST+MST sessions delivered twice weekly over 7 weeks. Assessments will be conducted at baseline, post-intervention, and after 14 weeks by the end of the interventions. Primary outcomes include proportion of responders on the Mini-Mental State Examination (≥2.32 points) and Timed Up and Go test (≥1 point). Secondary outcomes include cognitive, motor, functional, psychological, and caregiver-related measures.

Ethical approval was obtained from the Italian National Ethics Committee in July 2025 (reference number: 2025_0032251). Written informed consent will be obtained from participants and/or their legal representatives, as well as from caregivers involved in the study. All procedures will comply with the Declaration of Helsinki and national data protection regulations. Study findings will be disseminated through peer-reviewed scientific publications and presentations at national and international conferences.

Study Overview

• Status: Recruiting
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Cognitive Stimulation Therapy and Motor Stimulation Treatment

• Study Type: Interventional
• Enrollment (Estimated): 421
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ernesto Palummeri; Phone Number: +39 3312627145; Email: ernesto.palummeri@alisa.liguria.it

Study Locations

• Italy
  • Genova
    • Genova, Genova, Italy, 16132
      • Recruiting
      • Centre for Cognitive Disorders and Dementia "ASL 3 GENOVESE"
      • Contact: Claudio Ivaldi; Phone Number: +39 3477569654; Email: Claudio.Ivaldi@asl3.liguria.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age ≥ 65 years;
• having been assessed by a Center for Dementia and Cognitive Disorders (CCDD) who diagnosed dementia with any etiology of mild to moderate severity;
• being able to perform a Timed Up and Go test (TUG) regardless of the time taken, i.e. being able to walk independently or with assistance, but without the need for human help during the test;
• having no hearing or visual impairments of a degree that would preclude participation in the interventions.

Exclusion Criteria:

• presence of specific behavioural disorders (delusions, hallucinations, agitation, anxiety, euphoria, disinhibition, irritability, wandering) of a degree that prevents participation in the interventions;
• diseases that contraindicate physical activity (e.g. severe heart failure).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: People living with mild-to-moderate dementia; People living with mild-to-moderate dementia being able to perform a Timed Up and Go test (TUG) regardless of the time taken, i.e. being able to walk independently or with assistance, but without the need for human help during the test, and having no hearing or visual impairments of a degree that would preclude participation in the interventions.

Behavioral: Cognitive Stimulation Therapy and Motor Stimulation Treatment; The intervention will consist of a total of 14 sessions lasting 2 hours each over 7 weeks (twice a week). The intervention will be delivered in groups of 6-8 patients with similar cognitive abilities and will always be carried out by two operators, a psychologist and a physiotherapist. The space will be large enough to allow patients to walk easily in a circle; however, adjustments may be made (e.g. walking on the spot). Each session will consist of an initial 45-minute CST session followed by an MST session. The short break scheduled in the CST protocol will be postponed until the end of this intervention and before the MST session.; Other Names: CST; MST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini Mental State Examination (MMSE)	A screening neuropsychological test assessing cognitive global function. The total score is 30. Higher scores indicate better cognitive performance.	The test will be administered at baseline, at week 7 and at week 14
Timed and Up Go Test (TUG)	TUG test is a simple clinical measure of functional mobility and fall risk. It records the time (in seconds) needed to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Scores are interpreted as follows: lower times indicate better mobility, with <10 seconds generally considered normal, 10-20 seconds indicating mild mobility impairment, and >20-30 seconds suggesting increased fall risk and functional limitation, depending on clinical context.	Baseline, week 7, and week 14

Collaborators and Investigators

• Sponsor: Istituto Superiore di Sanità

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: dementia; cognitive stimulation therapy; combined intervention; cst; motor stimulation treatment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 2025_0032251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share individual participant data (IPD) including baseline demographic and clinical characteristics, outcome measures collected during and after the intervention (e.g., cognitive, functional, and motor assessments), and relevant safety/adverse event data. All shared IPD will be de-identified to ensure participant confidentiality.
• IPD Sharing Time Frame: At the end of the study
• IPD Sharing Access Criteria: Immediately after the first publication of the results. IPD wil be shared through scientific publications.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No