NCT06550258

Brief Summary

The purpose of this clinical review is to investigate the effect of hippotherapy in improving upper limb functionality in children with cerebral palsy. The main question it aims to answer is The questions are as follows:

  1. 1.Does hippotherapy improve gross motor function of the upper extremity in children with cerebral palsy?
  2. 2.Is the development of trunk control in children with cerebral palsy who receive hippotherapy different from the development of trunk control in children who receive conventional physiotherapy?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 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

Study Start

First participant enrolled

August 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

August 5, 2024

Last Update Submit

August 9, 2024

Conditions

Keywords

hippotherapyphysiotherapycerebral palsy

Outcome Measures

Primary Outcomes (2)

  • Box and block test

    This test evaluates manual dexterity. The person being tested is asked to move blocks from one compartment to the other compartment as fast as they can within 60 seconds. The test is started with the dominant hand and the test is repeated with both hands. In addition, a 15-second trial period is given for both hands. The blocks are held in the compartment on the side of the hand to be tested, and the test is started by positioning the box in the midline of the person being tested. When the time is up, the blocks carried are counted and the result is recorded.

    8 weeks

  • Trunk Control Measurement Scale

    The Trunk Control Measurement Scale includes 15 items that measure the two main components of trunk control, static and dynamic sitting balance. The Static Sitting Balance Scale (items 1-5) evaluates the ability to maintain stable trunk posture during movements of the upper and lower extremities. The Dynamic Sitting Balance Scale (items 6-15) is divided into two subscales: the selective movement control scale and the dynamic reach scale. The total score ranges from 0-58. A high score indicates good performance.

    8 weeks

Secondary Outcomes (3)

  • ABILHAND-Kids

    8 weeks

  • Moberg pickup test

    8 weeks

  • Gross Motor Function Measure

    8 weeks

Study Arms (2)

Hippotherapy group

EXPERIMENTAL

Hippotherapy was applied with a physiotherapist for 2 months.

Other: Equine-assisted therapy

Control group

ACTIVE COMPARATOR

Classical physiotherapy was applied with the help of a physiotherapist for 2 months.

Other: Traditional Pediatric Physiotherapy

Interventions

Hippotherapy is a therapeutic intervention applied by physiotherapists that aims to improve impaired body functions. Hippotherapy is a therapy in which the rider receives stimuli from the horse that stimulate the sensory, neuromotor and cognitive systems during riding and exercise on the back of a horse. Hippotherapy is effective on posture control, balance, gross motor functions and functional performance in children with cerebral palsy.

Hippotherapy group

In traditional pediatric physiotherapy, cushions of appropriate hardness were used for proprioceptive input. Stools of different heights were used for sitting, squatting, standing up by holding on and standing, Bobath balls and balance boards were used for balance reactions. Triangular and roll cushions of different hardness were used for weight transfer. Surfaces with different patterns were used for sensory input. The child's wishes and interests were taken into consideration in the selection of materials. The treatment was planned according to the activities that were difficult in daily life and the aim was to transfer the knowledge learned to daily life.

Control group

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Having been diagnosed with SP
  • Being between the ages of 4-16
  • Being at GMFCS (Gross Motor Function Classification System) level 1,2 or 3
  • Being at MACS (The Manual Ability Classification System) level 1,2,3 or 4
  • Having a stable clinical condition
  • Having the cognitive level to follow the instructions in the test and treatment protocol

You may not qualify if:

  • Families who do not sign the consent form
  • Presence of active seizures
  • Presence of developmental hip dysplasia
  • Presence of allergy to horses
  • Having undergone surgical intervention or Botulinum Toxin A (BTX-A) application in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University

Istanbul, Ümraniye, 34768, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Champagne D, Corriveau H, Dugas C. Effect of Hippotherapy on Motor Proficiency and Function in Children with Cerebral Palsy Who Walk. Phys Occup Ther Pediatr. 2017 Feb;37(1):51-63. doi: 10.3109/01942638.2015.1129386. Epub 2016 Mar 1.

    PMID: 26930110BACKGROUND
  • Park ES, Rha DW, Shin JS, Kim S, Jung S. Effects of hippotherapy on gross motor function and functional performance of children with cerebral palsy. Yonsei Med J. 2014 Nov;55(6):1736-42. doi: 10.3349/ymj.2014.55.6.1736.

    PMID: 25323914BACKGROUND
  • Kwon JY, Chang HJ, Yi SH, Lee JY, Shin HY, Kim YH. Effect of hippotherapy on gross motor function in children with cerebral palsy: a randomized controlled trial. J Altern Complement Med. 2015 Jan;21(1):15-21. doi: 10.1089/acm.2014.0021. Epub 2014 Dec 31.

    PMID: 25551626BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Animal Assisted TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Before - after trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 13, 2024

Study Start

August 1, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations