Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05297149
Other study ID # ssaka4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2020
Est. completion date January 25, 2021

Study information

Verified date March 2022
Source Halic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date January 25, 2021
Est. primary completion date January 4, 2021
Accepts healthy volunteers No
Gender All
Age group 4 Years to 14 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Haliç University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Halic University

Country where clinical trial is conducted

Turkey, 

References & 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. Review. — View 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: 10.1080/01942638.20 — View Citation

Portaro S, Cacciola A, Naro A, Cavallaro F, Gemelli G, Aliberti B, De Luca R, Calabrò 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04854122 - Blood Flow Regulation in Individuals With Down Syndrome - Training Study N/A
Completed NCT04020302 - Self-Monitoring Shopping Intervention N/A
Recruiting NCT01950624 - DS-Connect {TM}: The Down Syndrome Registry
Completed NCT04751136 - the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome Phase 2
Completed NCT04767412 - Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial N/A
Not yet recruiting NCT04037579 - Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
Completed NCT04536506 - Bobath and Vojta Therapy for DS N/A
Completed NCT02882698 - Performance Analysis in Down Syndrome on Mobile Phone N/A
Completed NCT01791725 - A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia Phase 2
Unknown status NCT01975545 - Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21 Phase 2
Completed NCT01808508 - Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome N/A
Terminated NCT00754052 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17 Phase 3
Terminated NCT00754013 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10 Phase 3
Completed NCT01256112 - Parent Supported Weight Reduction in Down Syndrome N/A
Completed NCT01313325 - Hippotherapy to Improve the Balance of Children With Movement Disorders N/A
Completed NCT01594346 - Multicenter Vitamin E Trial in Aging Persons With Down Syndrome Phase 3
Completed NCT05343468 - Life Skills Improved in Children With Down Syndrome After Using Assistive Technology N/A
Suspended NCT05755464 - Evaluation of Patients With Down Syndrome Compliance to Dental Therapy
Recruiting NCT04022460 - Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
Completed NCT04818437 - Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome N/A