NCT06500182

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

May 20, 2021

Last Update Submit

July 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Assessing Parkinson's disease Motor disorders

    06 weeks

  • Assessing Parkinson's disease severity of the non-motor symptoms

    06 weeks

  • Assessing Parkinson's disease Postural and walking disorders

    06 weeks

  • MRI in diagnosis differential in Parkinson's disease

    day 0

Study Arms (1)

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)

Other: hippotherapy sessions

Interventions

Patients benefit from the hippotherapy sessions in additional to continuing to receive traditional care.

hippotherapy sessions

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Saint-Quentin;

Saint-Quentin, Aisne, 02100, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Jadwiga ATTIER, PHD

    CH SAINT-QUENTIN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jadwiga ATTIER, PHD

CONTACT

Abdelkrim BOULANOUAR, M

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

July 15, 2024

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations