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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLNA SANTE

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Group Experimental : Standard Rehabilitation Combined with Animal-Assisted TherapyExperimental treatment 1 intervention
Group B: Group Control : Standard RehabilitationActive comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

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

The IADL (Lawton \& Brody) is an 8-item scale assessing functional independence in instrumental activities of daily living: telephone use, shopping, food preparation, housekeeping, laundry, transportation, medication management, and financial management. Each item scored 0 (dependent) or 1 (independent). Score range: 0 to 8; higher score = greater functional independence/autonomy.

Time frame
Baseline (Day 0, Week 1) and End of Study (Week 6, ± 7 days)
2

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

The ADRQL is a 40-item proxy-rated quality of life scale designed for people with dementia, assessing 5 domains: social interaction, awareness of self, feelings and mood, enjoyment of activities, and response to surroundings. Items rated binary by caregiver/clinician familiar with participant. Score range: 0 to 100; higher score = better quality of life.

Time frame
Baseline (Day 0, Week 1) and End of Study (Week 6, ± 7 days)
3

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

The Tinetti scale is a two-part observational assessment of balance and gait. Balance subscale: 16 items, scored 0-16. Gait subscale: 12 items, scored 0-12. Total score range: 0 to 28; higher score = better performance and lower fall risk. Risk categories: score \<19 = high fall risk; 19-24 = moderate fall risk; ≥25 = low fall risk.

Time frame
Baseline (Day 0, Week 1) and End of Study (Week 6, ± 7 days)
4

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

Total number of rehabilitation sessions attended by each participant over the 4-week rehabilitation period (Weeks 2-5), per allocated arm. Maximum possible: 8 sessions. This outcome measures participant adherence and engagement with the rehabilitation program, and allows comparison of session attendance rates between groups.

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

Other outcomes

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