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临床试验/NCT07730983
NCT07730983尚未招募不适用

Impact of a Combined Rehabilitation and Animal-Assisted Therapy Approach on the Recovery of Motor Abilities in Patients With Dementia Hospitalized in a Medical and Rehabilitation Care Unit

LNA SANTE1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
Change from Baseline in Motor Abilities as Assessed by the Geronto-Psychomotor Examination (EGP) at Week 6

研究概览

简要总结

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

详细描述

  1. Background and Rationale Dementia is a progressive syndrome characterized by cognitive decline beyond what is expected from normal aging, affecting memory, reasoning, orientation, comprehension, language, and judgment. According to the World Health Organization (WHO), approximately 50 million people worldwide are affected by dementia, with an estimated 10 million new cases per year. This figure is projected to reach 152 million by 2050, making dementia care a major global public health challenge.

Current pharmacological treatments for managing behavioral and psychological symptoms of dementia (BPSD) demonstrate limited efficacy and carry significant adverse effects. French health authorities (Haute Autorité de Santé, HAS) therefore recommend prioritizing non-pharmacological interventions (NPIs) as first-line approaches for symptom management. 2. Rationale for the Intervention Animal-Assisted Therapy (AAT) is a targeted, structured therapeutic intervention involving the introduction of trained animals into clinical care, delivered by qualified health professionals with documented assessment of participant progress. Based on the International Association of Human-Animal Interaction Organizations (IAHAIO) definition, AAT is a goal-directed intervention designed to promote therapeutic benefits in human health by introducing animals into care. It emphasizes improvement of physical, cognitive, behavioral, and/or socio-emotional functioning.

While AAT has been used since the 18th century, its scientific evidence base for dementia populations remains limited. A 2019 systematic review (Lai et al., Cochrane Database) identified only 9 eligible studies (6 RCTs, 2 cluster RCTs, 1 crossover RCT), showing that AAT may slightly reduce depressive symptoms in dementia patients, while evidence for effects on other outcomes (quality of life, other BPSD) remains inconclusive. Positive effects on agitation, depression, quality of life, and balance have been observed, but no study has specifically addressed the recovery of motor abilities in demented patients in a rehabilitation setting.

Since October 2021, the Institut Médical de Sologne (IMDS) has integrated AAT into the care program of elderly patients with dementia hospitalized in its geriatric medical and rehabilitation care unit (SMR). Clinical observation showed that patients resistant to or disengaged from standard rehabilitation became more accessible and demonstrated previously unseen motor capacities when in contact with trained animals. The therapeutic alliance between the nurse-animal therapist, psychomotor therapist, and nursing assistant appeared to facilitate patient engagement, improve therapeutic compliance, and unlock motor potential.

This exploratory pilot study aims to formally and objectively measure the impact of this combined approach on motor recovery. 3. Study Design RÉMÉDI-A is a prospective, single-center, cluster-randomized, open-label pilot study conducted in the geriatric SMR ward of the Institut Médical de Sologne (IMDS), 1 rue Cécile Boucher, 41600 Lamotte-Beuvron, France.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.)

结局指标

主要结局

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

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

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

次要结局

  • 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))

研究者

发起方
LNA SANTE
申办方类型
Other
责任方
Sponsor

研究点 (1)

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