Parkinson DiseaseEQUIDIANCT06500182
The Benefits of Hippotherapy for Patients With Parkinson's Disease of 75 Years
A study testing hippotherapy sessions in people with Parkinson Disease, run by Central Hospital Saint Quentin at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- hippotherapy sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.).
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Saint-Quentin;
Saint-Quentin, Aisne, 02100
ATTIER Dr Jadwiga, PI
About this study
Official title: 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.
Read the 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:
- Parkinson's disease begins late, after the age of 75, and the disease may progress relatively slowly if there are no co-morbidities.
- 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.
- Conditions
- Parkinson Disease
- Being tested
- hippotherapy sessions
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hippotherapy sessionsOther
Patients benefit from the hippotherapy sessions in additional to continuing to receive traditional care.
| Study group | Role | What they receive |
|---|---|---|
| hippotherapy sessions | Experimental | 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) Receives: Other: hippotherapy sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 06 weeks
Secondary outcomes (4)
Assessing Parkinson's disease Motor disorders
Motor disorders assessed by Mbientlab devices .
Measured: 06 weeks
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.
Measured: 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.
Measured: 06 weeks
MRI in diagnosis differential in Parkinson's disease
The usefulness of flow MRI in diagnosis differential in Parkinson's disease
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Jul 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital Saint Quentin
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jadwiga ATTIER, PHD, Principal investigator, CH SAINT-QUENTIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500182
- Sponsor's protocol ID
- 2020-A03105-34
- Acronym
- EQUIDIA
- Status last verified
- Jul 2024
- First submitted
- 20 May 2021
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Hippotherapy for Patients With Parkinson's Disease of 75 Years of Age or More at Risk of Losing Their Independance.
- ClinicalTrials.gov ID
- NCT06500182
- Acronym / sponsor ID
- EQUIDIA / 2020-A03105-34
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Central Hospital Saint QuentinOther government
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Parkinson's disease begins late, after the age of 75, and the disease may progress relatively slowly if there are no co-morbidities.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hippotherapy sessions | Experimental | Other: hippotherapy sessionsPatients 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) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hippotherapy sessionsPatients benefit from the hippotherapy sessions in additional to continuing to receive traditional care. | Other | hippotherapy sessions |
Primary outcome
Assessing quality of life in Parkinson's disease by PDQ8 questionnaires
Time frame: 06 weeks
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.
4 secondary outcomes
Assessing Parkinson's disease Motor disorders
Time frame: 06 weeks
Assessing Parkinson's disease severity of the non-motor symptoms
Time frame: 06 weeks
Assessing Parkinson's disease Postural and walking disorders
Time frame: 06 weeks
MRI in diagnosis differential in Parkinson's disease
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jadwiga ATTIER, PHD principal investigator
CH SAINT-QUENTIN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hippotherapy sessions in people with Parkinson Disease, run by Central Hospital Saint Quentin at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jadwiga ATTIER, PHD (0323065707 ext. 0033, a.attier@ch-stquentin.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing quality of life in Parkinson's disease by PDQ8 questionnaires (time frame: 06 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.