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Effect of Hippotherapy in Children With Down Syndrome

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hippotherapy
Home exrecises
Sponsored by
Halic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Down Syndrome focused on measuring Hippotherapy, Functional Mobility, Balance, Down Syndrome

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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.

Sites / Locations

  • Haliç University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hippotherapy group

Control group

Arm Description

Participants that are performed hippotherapy

Participants that are performed home exercise program

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2022
Last Updated
March 22, 2022
Sponsor
Halic University
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1. Study Identification

Unique Protocol Identification Number
NCT05297149
Brief Title
Effect of Hippotherapy in Children With Down Syndrome
Official Title
Effect of Hippotherapy on Balance, Functional Mobility, and Functional Independence in Children With Down Syndrome: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
January 4, 2021 (Actual)
Study Completion Date
January 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Halic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Hippotherapy, Functional Mobility, Balance, Down Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hippotherapy group
Arm Type
Experimental
Arm Description
Participants that are performed hippotherapy
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants that are performed home exercise program
Intervention Type
Behavioral
Intervention Name(s)
Hippotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home exrecises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pediatric Balance Scale (PBS)
Description
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
Title
Timed Up and Go Test (TUG)
Description
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
Title
Pediatric Functional Independence Measure for Children (WeeFIM)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with down syndrome being aged 4 to 14 years being voluntary 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seda Saka, PT, PhD
Organizational Affiliation
Haliç University
Official's Role
Study Director
Facility Information:
Facility Name
Haliç University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20927000
Citation
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.
Results Reference
result
PubMed Identifier
31106675
Citation
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.
Results Reference
result
PubMed Identifier
31342817
Citation
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.
Results Reference
result

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Effect of Hippotherapy in Children With Down Syndrome

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