NCT03548376

Brief Summary

The hippotherapy is a complementary therapeutic modality that seeks to promote changes in the functionality of children with cerebral palsy (CP). Knowing the domains in which this therapy causes both direct and indirect effects, and identify the mechanisms that produce their effects, contributes to broadening and deepening of the knowledge available on the hippotherapy. The main aim of this study was to evaluate changes in postural control and balance, gross motor function and quality of life (QoL) of children with CP undergoing hippotherapy for a period of six months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 7, 2018

Completed
Last Updated

June 7, 2018

Status Verified

June 1, 2018

Enrollment Period

9 months

First QC Date

May 24, 2018

Last Update Submit

June 5, 2018

Conditions

Keywords

rehabilitationcerebral palsypostural controlbalancegross-motor functionquality of lifehippotherapy

Outcome Measures

Primary Outcomes (2)

  • Change in Child's Postural control and balance

    The Early Clinical Assessment of Balance (ECAB) estimates the postural stability of the child according to head and trunk controls during static activities and dynamic activities

    From Pre-intervention to 3 months after intervention onset

  • Change in Child's Postural control and balance

    The Early Clinical Assessment of Balance (ECAB) estimates the postural stability of the child according to head and trunk controls during static activities and dynamic activities

    From 3 months to 6 months after intervention onset

Secondary Outcomes (3)

  • Change in Child's Gross Motor Function Measure (GMFM)

    From pre-intervention to 3 months after intervention onset

  • Change in Child's Gross Motor Function Measure (GMFM)

    From 3 months to 6 months after intervention onset (end on intervention period)

  • Change in Child's Quality of Life

    From pre-intervention to 6 months after intervention onset (end on intervention period)

Study Arms (1)

One-group intervention

EXPERIMENTAL

Hippotherapy sessions were delivered once a week for 30 minutes, during 6 months.

Other: Hippotherapy

Interventions

Hippotherapy is a therapeutic intervention that is typically conducted by a physical or occupational therapist and is aimed at improving impaired body function. Hippotherapy has been proposed as a technique to decrease the energy requirements and improve walking in patients with cerebral palsy. It is thought that the natural swaying motion of the horse induces a pelvic movement in the rider that simulates human ambulation. In addition, variations in the horse's movements can also prompt natural equilibrium movements in the rider.

Also known as: horse therapy, equine movement therapy
One-group intervention

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with medical diagnosis of cerebral palsy
  • Ages 4 to 12 years old

You may not qualify if:

  • Other CP-associated diagnoses (e.g., autism)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1. Zadnikar M, Kastrin A. Effects of hippotherapy and therapeutic horseback riding on postural control or balance in children with cerebral palsy: a meta-analysis. Dev Med Child Neurol. 2011;53: 684-691. 2. Whalen CN, Case-Smith J. Therapeutic effects if horseback riding on gross motor function in children with cerebral palsy: a systematic review. Phys Occup Ther Pediatr. 2012;32: 229-242. 3. Meregliano G. Hippotherapy. Phys Med Rehabil Clin North Am. 2004;15: 843-854. 4. Debuse D, Gibb C, Chandler C. Effects of hippotherapy on people with cerebral palsy from the users' perspective: a qualitative study. Phys Theor Pract. 2009;25(3): 174-192.. 5. Davis E, Davies B, Wolfe R, Raadsveld R, Heine B, Thomason P, et al. A randomized controlled trial of the impact of therapeutic horse riding on the quality of life, health, and function of children with cerebral palsy. Dev Med Child Neurol. 2009;51: 111-119. 6. McCoy SW, Bartlett DJ, Yocum A, Jeffries L, Fiss AL, Chiarello L, et al. Development and validity of the early assessment of balance for young children with cerebral palsy. Dev Neurorehabil. 2014; 17: 375-383. 7. Randall KE, Bartlett DK, McCoy SW. Measuring postural stability in young children with cerebral palsy: a comparison of 2 instruments. Pediatr Phys Ther, 2014;26: 332-337. 8. Cyrillo LT, Galvão MCS. Gross Motor Function Measure [GMFM-66 & GMFM-88] (Portuguese translated manual). São Paulo: Memnon; 2011. 9. Russel DJ, Rosenbaum PL, Cadman DT, Gowland C, Hardy S, Jarvis S. The gross motor function measure: a means to evaluate the effects of physical therapy. Dev Med Child Neurol. 1989; 31: 341-352. 10. Russel DJ, Avery LM, Rosenbaum PL, Raina, PS, Walter SD, Palisano RJ. Improved scaling of the gross motor function measure for children with cerebral palsy: evidence of reliability and validity. Physical Therapy, 2000;80: 873-885. 11. Waters E, Maher E, Salmon L, Reddihpugh D, Boyd R. Developing a new quality of life scale for children with cerebral palsy. Child: Care, Health and Develop. 2005; 31: 127-135. 12. Braccialli LMP, Braccialli AC, Sankako AN, Dechandt MLC, Almeida VC, Carvalho SMR. Quality of life questionnaire for children with cerebral palsy (CP QOL-CHILD): Translation and cultural adaptation to the Brazilian Portuguese language. J Hum Growth and Develop. 2013; 23(2): 154-163. 13. Shurtleff TL, Standeven JW, Engsberg JR. Changes in dynamic trunk/head stability and functional reach after hippotherapy. Arch Phys Med Rehabil. 2009;90: 1185-1195. 14. Casady RL, Nichols-Larsen DS. The effect of hippotherapy on ten children with cerebral palsy. Pediatr Phys Ther. 2004;16: 165-172. 15. Park ES, Rha DW, Shin JS, Kim S, Jung S. Effects of hippotherapy on gross motor function and functional performance of children with cerebral palsy. Yonsei Med J. 2014;55(6): 1736-1742. 16. Hammil D, Washington K, White OR. The effect of hippotherapy on postural control in sitting for children with cerebral palsy. Phys Occup Ther Pediatr. 2007;27: 23-42. 17. Galloux P, Richard N, Dronka T, Leard M, Perrot A, Jouffroy JL, et al. Analysis of equine gait using three-dimensional accelerometers fixed on the saddle. Equine Vet J. 1994; 17(Suppl.): 44-47. 18. Temcharoensuk P, Lekskulchai R, Akamanon C, Ritruechai P, Sutcharitpongsa S. Effect of horseback riding simulator on sitting ability of children with cerebral palsy: a randomized controlled trial. J Phys Ther Sci. 2015;27: 273-277.

    RESULT

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Marisa C Mancini, PhD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
the scoring of repeated evaluations was blinded regarding order. To do so, the scores of all of the instruments were calculated without the knowledge of which was the evaluation (T1, T2 or T3) or access to the previous scores of the same child. The GMFM-88 score was made by an examiner who did not participate in the data collection (evaluations and intervention). This examiner watched the videos and was blinded to the child's descriptive information and the order of the evaluation. The ECAB test score was calculated by two other external examiners who watched the videos and were also blinded regarding the same information.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Before-after trial (6 months of follow-up; one group with three repeated measurements)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2018

First Posted

June 7, 2018

Study Start

November 1, 2016

Primary Completion

August 12, 2017

Study Completion

February 1, 2018

Last Updated

June 7, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share