Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03548376
Other study ID # MMancini
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2016
Est. completion date February 1, 2018

Study information

Verified date June 2018
Source Federal University of Minas Gerais
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

We conducted a quasi-experimental study with 31 children with cerebral palsy from both sexes, of various types and GMFCS levels who were followed for 6 months with three repeated measurements: beginning of the study (T1), 3 months (T2) and 6 months (T3) after the initial evaluation. Participants were measured 3 times on postural control and balance, gross-motor function and twice on quality of life. Children attended hippotherapy session one a week for 30 minutes. Sessions were conducted by equestrian therapists (physiotherapists or occupational therapists) qualified by the National (Brazilian) Association of Hippotherapy. The horses were trained for hippotherapy practice, and each patient used the same animal in all sessions. The specific hippotherapy gear included safety straps, riding blankets, stirrups and saddles with and without support straps. The use of protective helmets for patients was mandatory in all sessions. Playful and educational toys were also used. The participants included the patient, the equestrian therapist, the horse handler (the professional who drives the horse) and, when necessary, an auxiliary helper to ensure the safety of the child. The hippotherapy sessions were individualized. The goals set by the therapist were based on the specific demands and the motor condition of each client. The activities proposed during each session sought to stimulate the development of the postural control of the child with CP. Such activities could be performed in various postures (i.e., classic, inverted, lateral, dorsal decubitus, ventral decubitus and standing on the stirrups). They included demands for stability and balance (i.e., trunk rotation activities, range in various directions and bimanual tasks), active stretches and antigravitational exercises during riding, integrated with ludic-cognitive resources (i.e., memory games and identification of colors, numbers and letters). For the most part, children with mild and moderate impairments rode individually and were encouraged to maintain an upright posture throughout the session. Those with more severe impairment were encouraged to maintain control and postural alignment, with the minimum of support being provided. In some cases, it was necessary to use a double riding strategy, in which the therapist rode the horse along with the patient to favor and stimulate the child's postural control on the animal. Throughout the session, the horse varied speed, cadence and direction to the therapist's command, using different paths (i.e., circles, zigzags and straight lines) and different types of terrain (i.e., uphill, downhill, dirt, asphalt and grass). All participants were instructed to continue with their rehabilitation routine (i.e., physical therapy, occupational therapy and others). For data analysis, participants were stratified by age (04-07 years and 08-12 years), severity (mild, moderate and severe), topography of the members involved (diplegia, hemiplegia, and quadriplegia) and previous time of hippotherapy (between 3-6 months and more than 6 months).


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date February 1, 2018
Est. primary completion date August 12, 2017
Accepts healthy volunteers No
Gender All
Age group 4 Years to 12 Years
Eligibility Inclusion Criteria:

- Children with medical diagnosis of cerebral palsy

- Ages 4 to 12 years old

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hippotherapy
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Minas Gerais

References & 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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Change in Child's Gross Motor Function Measure (GMFM) Assessed by the GMFM-88, which includes five dimensions: (A) Lying and Rolling, (B) Sitting, (C) Crawling and Kneeling, (D) Standing and (E) Walking, Running and Jumping. The item scores generate a score for each dimension and a total score. Higher scores give information on a greater repertoire of the gross motor function. From pre-intervention to 3 months after intervention onset
Secondary Change in Child's Gross Motor Function Measure (GMFM) Assessed by the GMFM-88, which includes five dimensions: (A) Lying and Rolling, (B) Sitting, (C) Crawling and Kneeling, (D) Standing and (E) Walking, Running and Jumping. The item scores generate a score for each dimension and a total score. Higher scores give information on a greater repertoire of the gross motor function. From 3 months to 6 months after intervention onset (end on intervention period)
Secondary Change in Child's Quality of Life Assessed by the Quality of Life Questionnaire for Children with Cerebral Palsy: questionnaire for primary caregivers (CPQOL-Child), which gives information on the wellbeing of children with CP between 4 and 12 years of age and was administered in an interview with key caregivers. This version has 66 questions organized in seven domains of QOL: social wellbeing and acceptance; functioning; participation and physical health; emotional wellbeing and self-esteem; access to services; pain and disability impact; and family health. Scoring is transformed into domain-specific percentages. From pre-intervention to 6 months after intervention onset (end on intervention period)
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2