Animal-Assisted Therapy Combined With Standard Rehabilitation for Motor Recovery in Dementia Patients in a Medical and Rehabilitation Care Unit

NCT07730983 | Not Yet Recruiting

• 1 other identifier: 2025-A02415-44
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized study is to find out if animal-assisted therapy (AAT) - a structured program where trained animals take part in care sessions guided by health professionals - can help improve movement abilities in older adults with dementia or memory-related conditions who are staying in a medical rehabilitation unit. The main questions this study aims to answer are:

• Can adding animal-assisted therapy to standard rehabilitation improve participants' movement and motor abilities better than standard rehabilitation alone?
• Can this combined approach help participants stay more independent in daily activities?
• Can this combined approach improve participants' quality of life?
• Can this combined approach reduce the risk of falls? Researchers will compare two groups:
• Group 1 (experimental): Standard rehabilitation + animal-assisted therapy sessions with a trained dog and/or rabbits
• Group 2 (control): Standard rehabilitation alone Both groups attend 2 one-hour rehabilitation sessions per week for 4 weeks. Participants will:
• Complete movement and daily-life ability tests at the start and end of the study
• Attend 8 rehabilitation sessions (over 4 weeks)
• Participants in the animal therapy group will interact with a trained dog and/or rabbits during sessions, guided by a certified nurse-animal therapist, a psychomotor therapist, and a nursing assistant
• Be assessed at the end of the 4-week program (Week 6) to measure any changes in motor abilities, independence, quality of life, and fall risk

Conditions

Dementia; Cognitive Dysfunction ( MMSE < 24 ); Motor Skills Disorders

Keywords

Dementia; Animal-Assisted Therapy; Motor Rehabilitation; Psychomotor Function; Geriatric Rehabilitation; Non-Pharmacological Intervention; Cognitive Decline; Medical and Rehabilitation Care

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Motor Abilities as Assessed by the Geronto-Psychomotor Examination (EGP) at Week 6

  The EGP (Examen Géronto-Psychomoteur) is a standardized French geriatric psychomotor assessment tool evaluating items 1 to 10.5 across domains including global motor function, balance and posture, fine motor skills and praxis, body schema, and sensory-motor function. Items are scored on discrete scales and combined to produce a composite psychomotor score. Higher scores indicate better psychomotor functioning. Scoring range per protocol assessment tools (Annex XIII). MCID not yet established in this population

  Baseline (Day 0, Week 1) and End of Study (Week 6, ± 7 days)

Secondary Outcomes (5)

• Change from Baseline in Functional Autonomy as Assessed by the Instrumental Activities of Daily Living (IADL) Scale at Week 6

  Baseline (Day 0, Week 1) and End of Study (Week 6, ± 7 days)

• Change from Baseline in Quality of Life as Assessed by the Alzheimer's Disease-Related Quality of Life (ADRQL) Scale at Week 6

  Baseline (Day 0, Week 1) and End of Study (Week 6, ± 7 days)

• Change from Baseline in Fall Risk as Assessed by the Tinetti Performance-Oriented Mobility Assessment at Week 6

  Baseline (Day 0, Week 1) and End of Study (Week 6, ± 7 days)

• Number of Psychomotor Rehabilitation or Animal-Assisted Therapy Sessions Attended Over the 4-Week Rehabilitation Period

  Weeks 2 to 5 (End of 4-week rehabilitation period)

• Change in Emotional, Social, and Motor Behavioral Dimensions as Assessed by a Qualitative Behavioral Grid at Each Rehabilitation Session (Weeks 2-5)

  At each of the 8 rehabilitation sessions (Weeks 2 to 5)

Study Arms (2)

Group Experimental : Standard Rehabilitation Combined with Animal-Assisted Therapy

EXPERIMENTAL

Standard rehabilitation program (physiotherapy, occupational therapy, adapted physical activity) plus structured animal-assisted therapy (AAT) sessions integrating psychomotor rehabilitation. Sessions led by a certified nurse-animal therapist, a psychomotor therapist, and a nursing assistant. Frequency: 2 sessions × 1 hour/week for 4 weeks (8 sessions total, max 2 participants/session). Animals: 1 dog (golden retriever/malinois cross) and/or 2-4 rabbits. Sessions address global motor function, balance, fine motor skills, body schema, and sensory stimulation.

Behavioral: Animal-Assisted Therapy

Group Control : Standard Rehabilitation

ACTIVE COMPARATOR

Standard rehabilitation program as delivered at Institut Médical de Sologne (IMDS), including physiotherapy, occupational therapy, adapted physical activity, and group psychomotor rehabilitation. Psychomotor therapy: 2 group sessions × 1 hour/week for 4 weeks (8 sessions total). Sessions cover fine and manual motor skills, static and dynamic coordination, posture, muscle tone, and praxis. This represents the recognized standard of care for patients with dementia in a French medical and rehabilitation care unit.

Behavioral: Standard psychomotor rehabilitation

Interventions

Animal-Assisted Therapy BEHAVIORAL

Structured AAT sessions integrating psychomotor rehabilitation, delivered by a certified nurse-animal therapist, psychomotor therapist, and nursing assistant. Frequency: 2 sessions × 1 hour/week for 4 weeks (8 sessions). Individualized therapeutic motor objectives defined before first session. Each session: (1) welcome/emotions check-in; (2) animal introduction and contact; (3) motor exercises across 5 domains: global motor function, balance/posture, fine motor skills/praxis, body schema, sensory-motor stimulation; (4) session debrief. Animals: 1 dog and/or 2-4 rabbits. Maximum 2 participants per session.

Also known as: AAT, Animal-Mediated Therapy

Group Experimental : Standard Rehabilitation Combined with Animal-Assisted Therapy

Standard psychomotor rehabilitation BEHAVIORAL

Group psychomotor rehabilitation sessions led by the establishment's certified psychomotor therapist. Frequency: 2 group sessions × 1 hour/week for 4 weeks (8 sessions total). Sessions address fine and manual motor skills, static and dynamic coordination, posture, muscle tone, and praxis. Participants also receive individualized physiotherapy, occupational therapy, and adapted physical activity as part of standard geriatric rehabilitation care.

Also known as: Standard rehabilitation

Group Control : Standard Rehabilitation

Eligibility Criteria

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

You may qualify if:

• Hospitalized in the geriatric medical and rehabilitation ward (SMR) of Institut Médical de Sologne (IMDS)
• Diagnosed dementia or confirmed cognitive decline, shown by a score between 15 and 24 on the Mini-Mental State Examination (MMSE - a short standardized test of memory and thinking)
• Has active motor rehabilitation goals (identified need to improve movement abilities during hospitalization)
• Participant and/or their legal guardian, trusted person (personne de confiance), curator, or family member has provided written consent to participate in the study
• Affiliated to a French social security scheme

You may not qualify if:

• Known allergy to the animals used in the animal-assisted therapy sessions (dog, rabbits)
• Fear of animals
• History of aggressive behavior toward animals
• Concomitant psychiatric disorders
• Needs only a stimulation and/or skills maintenance approach (no active motor rehabilitation goals)
• Currently enrolled in another interventional research study
• (Note: A participant who was previously enrolled in another interventional study may join RÉMÉDI-A once their participation in the prior study has ended, without a washout period, provided all eligibility criteria are met.)

Sponsors & Collaborators

• LNA SANTE: lead

Study Sites (1)

Institut Médical de Sologne LNA Santé

Lamotte-Beuvron, 41600, France

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Motor Skills Disorders

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rodrigue DR SAGBO

  Institut Médical de Sologne LNA Santé

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva MRS BRIAND

CONTACT

(0)240160161 ext +33; eva.briand@lna-sante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, single-center, cluster-randomized pilot study

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

FR (1)