NCT05297149

Brief Summary

Purpose: The aim of this study was to determine the effect of hippotherapy on balance, functional mobility, and functional independence in children with Down syndrome (DS). Methods: Thirty-four children with DS were randomly assigned to the experimental (hippotherapy) and control groups after initial assessment. Both groups received physiotherapy including balance exercises, and the experimental group also received hippotherapy. Pediatric Balance Scale (PBS), Timed Up and Go Test (TUG), and Functional Independence Measure for Children (WeeFIM) were used before and after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2021

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

March 4, 2022

Last Update Submit

March 22, 2022

Conditions

Keywords

HippotherapyFunctional MobilityBalanceDown Syndrome

Outcome Measures

Primary Outcomes (3)

  • Pediatric Balance Scale (PBS)

    The PBS is a modified version of the Berg Balance Scale that is used to assess functional balance skills in children with mild to moderate motor impairment. The scale consists of 14 items that are scored from 0 (lowest function) to 4 (highest function) with a maximum score of 56 points. Lower scores indicate poorer balance. The PBS has been validated for use in children with neuromotor dysfunction.

    Change from baseline PBS at 6th week

  • Timed Up and Go Test (TUG)

    The TUG assesses balance and functional mobility. The time required for the person to stand up from a chair, walk 3 meters forward, return to the chair, and sit down again was recorded. Times of 14 seconds or more are interpreted as high risk of falling. The TUG was reported to be reliable for assessing functional mobility in people with DS.

    Change from baseline TUG at 6th week

  • Pediatric Functional Independence Measure for Children (WeeFIM)

    The WeeFIM is a pediatric version of the Functional Independence Measure (FIM) that was developed to measures a child's consistent functional performance in essential daily functional skills (independence in self-care, sphincter control, transfers, locomotion, communication, and social cognition). It is an 18-item, 7-level ordinal scale instrument (score range: 18-126) and can be used for children with developmental disabilities aged 6 months to 21 years.

    Change from baseline WeeFIM at 6th week

Study Arms (2)

hippotherapy group

EXPERIMENTAL

Participants that are performed hippotherapy

Behavioral: Hippotherapy

Control group

ACTIVE COMPARATOR

Participants that are performed home exercise program

Behavioral: Home exrecises

Interventions

HippotherapyBEHAVIORAL

The hippotherapy program consisted of 6 weekly sessions that varied in duration between 20 and 30 minutes depending on the weekly program and the participant's condition. Each session started with brief greetings and contact with the horse.

hippotherapy group
Home exrecisesBEHAVIORAL

The home exercise program consisted of the following balance training exercises: one leg standing on foam with eyes open and closed, double leg standing on foam with eyes open and closed, walking in tandem with eyes open and closed, balance exercises on an inclined surface, balance exercises in squat, and jumping over an obstacle on the ground. All participants performed the exercises under parental supervision, 3 times per week for 6 weeks. The physiotherapist made video calls to the children and parents to ensure their adherence to the home exercise program.

Control group

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosed with down syndrome
  • being aged 4 to 14 years
  • being voluntary

You may not qualify if:

  • having a history of previous hippotherapy intervention,
  • having a phobia related to horse riding, epileptic seizures, atlantoaxial instability, and
  • having any orthopedic, neurological, or cardiovascular disease that prevents physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haliç University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Bronson C, Brewerton K, Ong J, Palanca C, Sullivan SJ. Does hippotherapy improve balance in persons with multiple sclerosis: a systematic review. Eur J Phys Rehabil Med. 2010 Sep;46(3):347-53. Epub 2010 Apr 13.

  • Moriello G, Terpstra ME, Earl J. Outcomes following physical therapy incorporating hippotherapy on neuromotor function and bladder control in children with Down syndrome: A case series. Phys Occup Ther Pediatr. 2020;40(3):247-260. doi: 10.1080/01942638.2019.1615601. Epub 2019 May 20.

  • Portaro S, Cacciola A, Naro A, Cavallaro F, Gemelli G, Aliberti B, De Luca R, Calabro RS, Milardi D. Can Individuals with Down Syndrome Benefit from Hippotherapy? An Exploratory Study on Gait and Balance. Dev Neurorehabil. 2020 Aug;23(6):337-342. doi: 10.1080/17518423.2019.1646830. Epub 2019 Jul 25.

MeSH Terms

Conditions

Down Syndrome

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Seda Saka, PT, PhD

    Haliç University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT PhD

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 28, 2022

Study Start

November 30, 2020

Primary Completion

January 4, 2021

Study Completion

January 25, 2021

Last Updated

March 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations