NCT05518370

Brief Summary

Hippotherapy simulators imitate the passive movements of the horse, producing simple movements similar to those of the horse. Hippotherapy simulators are intended to improve sitting balance, postural control and trunk balance. The aim of this study was to research the therapeutic effects of hippotherapy simulator on sitting balance, trunk control and upper extremity skills in individuals with Cerebral Palsy (CP).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 26, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

August 23, 2022

Last Update Submit

May 5, 2024

Conditions

Keywords

Cerebral palsyHippotherapy simulator

Outcome Measures

Primary Outcomes (7)

  • Gross Motor Function Classification System (GMFCS)

    Assessing functional level and motor function. Gross motor functions of children with CP are classified in five levels with GMFCS. This is a classification system based on the child's self-initiated movements with emphasis on sitting, displacement and mobility.

    At Baseline

  • Manuel ability classification system (MACS)

    This is a classification system based on the grasping and releasing objects in daily life, and how they use their hands while holding objects. It is classify the hand skills of children with CP between the ages of 4-18.Children with CP are classified in five levels with MACS. The higher level indicates worse hand function

    At Baseline

  • Change from Baseline Gross Motor Function Measure-88 at 8 weeks

    It is used to show gross motor functions and changes in these functions. It consists of five main sections. Each section can be used by calculating separately within itself. The total score ranges from 0 to 100, with a high score indicating better function.

    Change from Baseline at 8 weeks

  • Change from Baseline Trunk Control Measurement Scale at 8 weeks

    This scale consists of two main parts as dynamic and static sitting balance. The scale consists of 15 questions. The scoring of the items is 0, 1, 2 or 3. The total score ranges from 0 to 58, with a high score indicating better trunk control.

    Change from Baseline at 8 weeks

  • Change from Baseline Pediatric Evaluation of Disability Inventory at 8 weeks

    The Pediatric Evaluation of Disability Inventory (PEDI) is designed for the functional evaluation of children with special needs. This will be used to evaluate functional ability and performance. 0: can not do, 1: can do in the form of scoring is done. At the end of the evaluation, the points of the related section are collected. Higher score indicates a better level of functional independence.

    Change from Baseline at 8 weeks

  • Change from Baseline ABILHAND-Kids at 8 weeks

    Abilhand Kids evaluates manual ability in children with upper extremity disorders. It consists of 21 items and confirmed in CP. The lowest score that can be obtained from the scale is 21 and the highest score is 63. It can be stated that higher scores correspond to more difficulty in activities.

    Change from Baseline at 8 weeks

  • Change from Baseline The Jebsen Taylor Hand Function Test at 8 weeks

    The Jebsen Taylor Hand Function Test (JTHFT) will be used to evaluate hand function in daily life. Both hands are tested separately. The time for all activities is recorded with a stopwatch. Higher duration indicates worse hand function.

    Change from Baseline at 8 weeks

Study Arms (2)

Hippotherapy simulator training group

EXPERIMENTAL

Hippotherapy simulator training group will receive a traditional physiotherapy and hippotherapy simulator training, two days a week for a total of 8 weeks (30 minutes traditional physiotherapy session+15 minutes hippotherapy simulator training).

Other: Hippotherapy simulator trainingOther: Traditional physiotherapy

Traditional physiotherapy group

ACTIVE COMPARATOR

Traditional physiotherapy group individuals will be given a traditional physiotherapy two days per week for a total of 8 weeks (traditional physiotherapy session will last 45 minutes).

Other: Traditional physiotherapy

Interventions

Hippotherapy simulator training will be designed for the individual basis.

Hippotherapy simulator training group

Traditional physiotherapy within a specific program

Hippotherapy simulator training groupTraditional physiotherapy group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of Spastic Cerebral Palsy voluntary participation
  • Age between 4-18 years,
  • GMFCS Level I-II-III
  • MACS Level I-II-III
  • Have the ability to sit upright with support

You may not qualify if:

  • Not voluntary to participate in the research,
  • Botox in the last 6 months
  • Hip or spine surgeries in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep

Gaziantep, 27010, Turkey (Türkiye)

Location

Related Publications (1)

  • Gozacan Karabulut D, Numanoglu Akbas A. The effect of horse riding simulator on upper extremity skills, trunk control and functionality in cerebral palsy: a randomized controlled trial. Disabil Rehabil. 2025 Apr;47(7):1725-1732. doi: 10.1080/09638288.2024.2380785. Epub 2024 Jul 18.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Demet GÖZAÇAN KARABULUT

    Gaziantep Islam Science and Technology University

    STUDY DIRECTOR

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
Assistant Professor

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 26, 2022

Study Start

August 26, 2022

Primary Completion

July 10, 2023

Study Completion

September 15, 2023

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations