Effect of Hippotherapy in Children With Down Syndrome

Sponsor

Halic University (Other)

Overall Status

Completed

CT.gov ID

NCT05297149

Collaborator

(none)

Enrollment

Location

Arms

1.8

Actual Duration (Months)

18.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome	Behavioral: Hippotherapy Behavioral: Home exrecises	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Effect of Hippotherapy on Balance, Functional Mobility, and Functional Independence in Children With Down Syndrome: A Randomized Controlled Trial

Actual Study Start Date :

Nov 30, 2020

Actual Primary Completion Date :

Jan 4, 2021

Actual Study Completion Date :

Jan 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hippotherapy group Participants that are performed hippotherapy	Behavioral: Hippotherapy 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.
Active Comparator: Control group Participants that are performed home exercise program	Behavioral: Home 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.

Arm

Intervention/Treatment

Experimental: hippotherapy group

Participants that are performed hippotherapy

Behavioral: Hippotherapy

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.

Active Comparator: Control group

Participants that are performed home exercise program

Behavioral: Home 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.

Outcome Measures

Primary Outcome Measures

Pediatric Balance Scale (PBS) [Change from baseline PBS at 6th week]
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) [Change from baseline TUG at 6th week]
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) [Change from baseline WeeFIM at 6th week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 14 Years

Sexes Eligible for Study:

All

Accepts 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.