NCT06554171

Brief Summary

The hippotherapy simulator imitates the three-dimensional mechanical movement and walking of the horse and transfers the mechanical effect to the rider during hippotherapy. The aim of this study was to investigate the effect of exercise program with hippotherapy simulator on upper extremity functions and trunk control of individuals with cerebral palsy.All individuals diagnosed with Cerebral Palsy who agree to participate in the study and meet the inclusion criteria will be randomly divided into two groups as Study and Control Group. In addition to conventional physiotherapy, the study group will be trained in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.n addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks. However, the simulator will be kept in closed position to prevent oscillations.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

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

August 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

August 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 13, 2024

Last Update Submit

August 13, 2024

Conditions

Keywords

Cerebral palsyHippotherapy smilatorUpper extremity

Outcome Measures

Primary Outcomes (1)

  • Hand Function assessment

    Jabson Taylor hand function test will be used. The test measures the accuracy of speed and performance on a variety of grip and release tasks using everyday items.

    2 minutes

Secondary Outcomes (2)

  • Trunk control assessment

    2 minutes

  • Balance assessment

    2 minutes

Study Arms (2)

Hippotherapy group

EXPERIMENTAL

In addition to conventional physiotherapy, training will be given in the Hippotherapy Simulator for 15 minutes a day, 5 days a week for 4 weeks. The hippotherapy simulator serves a wide range of purposes from recreational use that mimics the movements of a real horse or can make similar movements, to fitness, exercise, sports, education and therapy and is suitable for use by individuals with cerebral palsy.

Other: Hippotherapy group

Control group

EXPERIMENTAL

In addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks. However, the simulator will be kept in closed position to prevent oscillations.

Other: Control group

Interventions

In addition to conventional physiotherapy, training will be given in the Hippotherapy Simulator for 15 minutes a day, 5 days a week for 4 weeks. The hippotherapy simulator serves a wide range of purposes from recreational use that mimics the movements of a real horse or can make similar movements, to fitness, exercise, sports, education and therapy and is suitable for use by individuals with cerebral palsy.

Hippotherapy group

In addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks. However, the simulator will be kept in closed position to prevent oscillations.

Control group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being between 6-18 years old
  • Being diagnosed with unilateral spastic type cerebral palsy
  • Voluntariness of the family and individuals to participate in the study
  • Being at I, II, III level according to the Hand Skills Classification System
  • To have the cognitive development to cooperate

You may not qualify if:

  • Having undergone any orthopedic and/or neurological surgery and/or BoNT A operation within the last 6 months
  • Having a history of epilepsy
  • Hearing and/or vision loss at a level that prevents participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songul Baglan Yentur

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Firat University

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 15, 2024

Study Start

August 20, 2024

Primary Completion

October 20, 2024

Study Completion

October 30, 2024

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations