The Benefits of Hippotherapy for Patients With Parkinson's Disease of 75 Years (EQUIDIA)

The Benefits of Hippotherapy for Patients With Parkinson's Disease of 75 Years of Age or More at Risk of Losing Their Independance.

There is no cure for Parkinson's disease, resulting in an interest for research in this domain. Non pharmacological measures remain essential, specifically physical activity. Hippotherapy is a nonconventional method which uses the horse in addition to standard care. The goal being to improve or maintain the gains of the person through cognitive, sensorial and motor stimulation, with the aim of improving quality of life and maintaining independence. With this in mind, the researchers propose to evaluate quality of life as the main criterion, using the PDQ8 scale validated for this disease. The researchers hope results will lead to the coverage of the costs of non-conventional therapies such as hippotherapy by social security services.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: hippotherapy sessions

Detailed Description

Parkinson's disease is a degenerative disorder with a prevalence of 2.50 patients per 1,000 people in 2015. Prevalence and incidence increase progressively with age up to the age of 80; more than half of patients are over 75.

There are two main types of Parkinson's disease in the elderly:

1. Parkinson's disease begins late, after the age of 75, and the disease may progress relatively slowly if there are no co-morbidities.
2. Or Parkinson's disease has been evolving for a long time, starting on average around the age of 55, and in this situation a number of difficulties arise depending on how long the disease has been present, the association of motor and non-motor fluctuations, the emergence of axonal signs and a decline in the severity of the disease, signs and a decline in cognitive function.

The therapeutic management of Parkinson's disease in the elderly must be assessed on a case-by-case basis. The efficacy/tolerance ratio of dopaminergic treatments must be taken into account.

In Alzheimer's disease (AD), it has been shown that aerobic exercise can delay cognitive decline. With this in mind, the researchers would like to propose a new and original approach using equitherapy in elderly Parkinson's patients.

The aim of this therapy will be to improve patients' quality of life, particularly in terms of well-being, maintain and encourage their autonomy and promote social interaction.

Equitherapy is an unconventional therapy which uses the horse as a complement to the treatment. For the EQUIDIA study, the researchers have suggested using the PDQ-8 score, validated for this condition, to evaluate quality of life as well as well-being and cognitive capacity for a group of Parkinson's patients over the age of 75 following 6 therapy sessions.Their Parkinson's diagnosis is to be confirmed through morphological and phase contrast MRI. The sessions will take place at the same interval of time following the administration of any dopaminergic medication. Progress will be recorded by the hippotherapy therapist using an evaluation developed by a horse-riding instructor. Sessions will be evaluated using inertia measurement devices to analyze quality of movement and the effect of specific activites with the horse.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jadwiga ATTIER, PHD; Phone Number: 0033 0323065707; Email: a.attier@ch-stquentin.fr
• Study Contact Backup: Name: Abdelkrim BOULANOUAR, M; Phone Number: 0033 03323067861; Email: a.boulanouar@ch-stquentin.fr

Study Locations

• France
  • Aisne
    • Saint-Quentin, Aisne, France, 02100
      • Recruiting
      • Centre Hospitalier de Saint-Quentin;
      • Contact: ATTIER Dr Jadwiga, PI

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age ≥ 75 years with PD according to Movement Disorders Society criteria (2015).
• Clinical diagnosis of Alzheimer's disease
• Has been on stable antiparkinsonian treatment for less than 3 months.
• Ability to understand the principle of the study as well as its risks.
• Written consent to participate in the trial.
• Have social insurance
• Agree to comply with all safety procedures during the study and its duration.
• Ability to understand and freely give consent
• Patient affiliated to social security or entitled beneficiary
• Autonomy preserved

Exclusion criteria :

• age <75 years
• refusal to sign consent
• MOCA <23
• Presence of major behavioural problems that do not allow MRI to be performed under optimal conditions
• Subjects unable to receive informed information, unable to participate in the study as a whole
• Subjects with a diagnosis of atypical parkinsonian syndrome (Lewy body disease, progressive supranuclear palsy, multisystem atrophy, cortico-basal degeneration, etc.).
• A classic contraindication to an MRI examination: claustrophobia, presence of incompatible foreign material,
• Subjects who have practised horse riding at a high level, animal phobias, wish to stop studying, etc.
• No affiliation to a social security scheme
• Antiparkinsonian treatment has not been stable for at least 3 months.
• People under protective supervision (guardianship, curatorship)
• People under family guardianship are also excluded, as are people for whom a mandate for future protection has been activated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• 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: hippotherapy sessions; Patients will benefit from the hippotherapy sessions in additional to continuing to receive traditional care ,To evaluate any differences between the initial visit and the evaluation following 6 weeks in PDQ8 scores, which contain 8 items given a score between 0 (never) and 4 (always)	Other: hippotherapy sessions; Patients benefit from the hippotherapy sessions in additional to continuing to receive traditional care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing quality of life in Parkinson's disease by PDQ8 questionnaires	changes from baseline in PDQ8 scores, which contain 8 items given a score between 0 (never) and 4 (always) maximum control; range, 0 to 32.	06 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing Parkinson's disease Motor disorders	Motor disorders assessed by Mbientlab devices .	06 weeks
Assessing Parkinson's disease Postural and walking disorders	Postural and walking disorders assessed by the Gait and Balance Scale (GABS) 33 (maximum control; range, 0 to 95). changes from baseline in severity motor signs of Parkinson's disease,assessed by the motor score of the MDS UPDRS scale.	06 weeks
MRI in diagnosis differential in Parkinson's disease	The usefulness of flow MRI in diagnosis differential in Parkinson's disease	day 0
Assessing Parkinson's disease severity of the non-motor symptoms	The severity of the non-motor symptoms of Parkinson's disease assessed by the score on the non-motor symptoms assesment scale for Parkinson's Disease. This is a 30-question questionnaire. For each question, a severity score ranging from 0 (none) to 3 (severe) and a frequency score ranging from 1 (rarely) to 4 (very frequent) are to be indicated.	06 weeks

Collaborators and Investigators

• Sponsor: Central Hospital Saint Quentin
• Investigators: Principal Investigator: Jadwiga ATTIER, PHD, CH Saint-Quentin

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2020-A03105-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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