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CompletedNCT05297149Updated Mar 28, 2022

Effect of Hippotherapy in Children With Down Syndrome

An interventional study of Hippotherapy and Home exrecises in Down Syndrome, sponsored by Halic University. Completed at 1 site in Turkey. Open to participants aged 4 Years to 14 Years. Per ClinicalTrials.gov, last updated 2022-03-28.

Sponsored by Halic University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Nov 2020, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
4 Years to 14 Years
Sex
All
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Down Syndrome

Keywords

  • Hippotherapy
  • Functional Mobility
  • Balance
  • Down Syndrome
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In context

Down Syndrome

432 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.

This study's enrollment of 34 is close to the median of 36 across 283 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

Halic University is the lead sponsor of 80 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    hippotherapy group

    Participants that are performed hippotherapy

    Behavioral: Hippotherapy

  • Active comparator
    Control group

    Participants that are performed home exercise program

    Behavioral: Home exrecises

Interventions

  • BehavioralHippotherapy

    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.

  • BehavioralHome exrecises

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline PBS at 6th week

  2. 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.

    Time frame: Change from baseline TUG at 6th week

  3. 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.

    Time frame: Change from baseline WeeFIM at 6th week

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Study locations

1 site
  • Haliç University
    Istanbul, Turkey
08

References and documents

Publications

  • 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. PubMed 20927000 ↗
  • 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. PubMed 31106675 ↗
  • 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. PubMed 31342817 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05297149
Lead sponsor
Halic University
Responsible party
Seda Saka (PT PhD, Halic University) — Principal investigator
First posted
Mar 28, 2022
Start date
Nov 30, 2020
Primary completion
Jan 4, 2021
Completion
Jan 25, 2021
Last update
Mar 28, 2022

Study contacts

Seda Saka, PT, PhD
study director · Haliç University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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