- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06662578
Using Equine Therapy in Dementia Cognitive Stimulation (ETMW_DEM)
Exploring Neurocognitive Stimulation in Dementia Through Equine-Assisted Therapy: A RCT Pilot Study
The goal of this clinical trial is to learn if integrating equine therapy in memory workshops in mild to moderate Dementias can improve cognitive function, quality of life and mood. The main question[s] it aims to answer is:
Does the mediation of a horse in memory workshops increase its effects ?
Researchers will compare traditional memory workshops, memory workshops using equine therapy and a control group to see if the equine therapy mediation will increase cognitive functions, mood and quality of life in individuals with mild to moderate Dementias.
Participants will participate in 8 weekly sessions of equine therapy memory workshops / traditional memory workshops / a control group will not have any interventions during that period. All subjects will be evaluated pre and post intervention period.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Le Boulou, France, 66160
- CAJOU
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have been medically diagnosed with Major Neurocognitive Disorders
- Scores between 0.5 and 2 on the Cognitive Dementia Rating scale (CDR) (Berg, 1982)
- Adults of all genders, aged 65 and over; and
- Willingness to participate in a memory workshop; e) willingness to interact with a horse.
Exclusion Criteria:
- Expressed fear, aversion, or has had a negative experience with horses
- Allergy or other medical condition which did not allow contact with horses.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
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Active Comparator: Traditional memory workshop
Neurocognitive stimulation as usual
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The participants received 8 weekly sessions of 60 minutes of neurocognitive stimulation, based on French memory workshops.
Other Names:
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Experimental: Equine assisted therapy memory workshop
Neurocognitive stimulation mediated with a horse based on a defined protocol.
|
The participants received 8 weekly sessions of 60 minutes, based on traditional memory workshops (French type of neurocognitive stimulation) with the mediation of a horse (example : working on associative memory by selecting which object is used for the horse between 2 presented objects).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline and ten weeks after
|
Pre and post-intervention period, the Montreal Cognitive Assessment was used to assess cognitive function. Score range: 0 to 30; higher scores indicate better cognitive function |
Baseline and ten weeks after
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Depression Symptoms as Assessed by the Geriatric Depression Scale (GDS-15)
Time Frame: Baseline and ten weeks after
|
Assessment of depression levels pre and post-intervention using the Geriatric Depression Scale - 15 items Score range: 0 to 15; higher scores indicate more depressive symptoms (worse outcome).
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Baseline and ten weeks after
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Change in Quality of Life as Assessed by the Quality of Life in Alzheimer's Disease (QoL-AD NH)
Time Frame: Baseline and ten weeks after
|
Assessment of the quality of life pre and post intervention using the Quality of life in Alzheimer's Disease - Nursing homes . The scale includes 15 items, each rated 1 to 4, for a total score ranging from 15 to 60; higher scores indicate better quality of life. |
Baseline and ten weeks after
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Behavioral Symptoms
- Neurocognitive Disorders
- Behavior
- Depression
- Dementia
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Animal Assisted Therapy
- Equine-Assisted Therapy
Other Study ID Numbers
- 05/CE-UICS/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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