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Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03870893
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Collaborator:
National Research Foundation of Korea
Information provided by (Responsible Party):
Jeong Yi Kwon, Samsung Medical Center

Brief Summary:
This research analyzes whether hippotherapy improves the physical activity, cardiopulmonary fitness, and attention in children with cerebral palsy and whether this enhances their general health and quality of life.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Physical Activity Attention Disorder Behavioral: hippotherapy Not Applicable

Detailed Description:

This research aims to promote hippotherapy by scientifically proving its therapeutic effects and mechanism to contribute to improving the health and quality of life of the patients as well as reducing their global burden of disease by shifting the current passive "therapy-oriented" paradigm to a more proactive "participation-oriented" paradigm.

Ever since physical activity and physical fitness have been reported to have an inverse relationship with the mortality rate, especially deaths due to cardiovascular disease, various efforts have been made to optimize physical activity and physical fitness among children with cerebral palsy. ADHD is one of the most common coexisting conditions of cerebral palsy. More participation in engaging sports activities like therapeutic riding is anticipated to improve patient health and their quality of life.

Hippotherapy is expected to improve clinical symptom of ADHD in children with cerebral palsy while preventing possible ensuing psychiatric disorders, thereby bringing significant improvement in their health and quality of life.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Hippotherapy on Physical Activities, Cardiopulmonary Fitness and Attention in Children With Cerebral Palsy
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Effect of hippotherapy in cerebral palsy

Effect of 16 weeks hippotherapy program in children with cerebral palsy

  • duration: 16weeks
  • frequency: 2 times per week
  • time: 40 minutes
Behavioral: hippotherapy
16weeks hippotherapy program




Primary Outcome Measures :
  1. change of GMFM88 [ Time Frame: change in baseline GMFM88 at 16weeks ]
    Gross Motor Function Measure; total 88 question, Each item is scored from 0-3 points. The items in each steps evaluated are expressed as a percentage of the total score for each step, and the percentage of the total score of all 88 items is indicated by GMFM-88. higher values represent a better outcome

  2. change of physical fitness [ Time Frame: change in baseline maximal oxygen consumption at 16weeks ]
    maximal oxygen consumption(ml/kg/min) during graded exercise test

  3. change of physical activity(%) [ Time Frame: change in baseline physical activity at 16weeks ]
    The sedentary/light/moderate/vigorous physical activity(%) during the day using ActiGraph(AMI, Ardsley, NY, USA)

  4. change of physical activity(step) [ Time Frame: change in baseline steps at 16weeks ]
    steps(counts) during the day using ActiGraph(AMI, Ardsley, NY, USA)

  5. change of attention [ Time Frame: change in baseline child behavior at 16weeks ]
    Child Behavior Checklist; The Social Ability Scale consists of Sociality Scale and Academic Performance Scale. The Scale of Problem Behavior Syndrome consists of 113 items related to problem behavior, and 13 (Sociality, Learning Problem, Total Social Ability, Atrophy, , Depression, social immaturity, thinking problems, attention problems, flying, aggression, internalization problems, externalizing problems, total problem behaviors). For each question, the scale is to be rated as 3-point Likert scale, the raw scores of all subscales are converted to standardized T scores . The higher the score, the higher the tendency toward problem behavior.


Secondary Outcome Measures :
  1. change of body composition [ Time Frame: change in baseline height at 16weeks ]
    height(meters)

  2. change of body composition [ Time Frame: change in baseline weight at 16weeks ]
    weight(kilograms)

  3. change of body composition [ Time Frame: change in baseline %fat at 16weeks ]
    %fat; using Inbody 12.0 (Biospace, Seoul, Korea)

  4. change of children health [ Time Frame: change in baseline children health at 16weeks ]
    Child Health Questionnaire Parent Form 50 (CHQ-PF50) Questions; total 50 questions, 4 or 6 score Likert scale, the score range is from 0 to 100, higher values represent a better outcome

  5. chagne of physical fitness [ Time Frame: change in baseline timed up and go at 16weeks ]
    ① Stand up from the chair without support. ② Walk 3m from chair. ③ Turn around. ④ Sit back in the chair. Measure the time(second), higher values represent a worse outcome

  6. change of physical fitness [ Time Frame: change in baseline maximal heart rate at 16weeks ]
    maximal heart rate(beats/min) during graded exercise test

  7. change of physical fitness [ Time Frame: change in baseline blood pressure at 16weeks ]
    blood pressure(mmHg) during graded exercise test

  8. change of physical fitness [ Time Frame: change in baseline Pediatric balance scale at 16weeks ]
    Pediatric balance scale; total 14 question, Each item is scored from 0-4 points. The total score is the sum of the scores obtained from all the items. higher values represent a better outcome

  9. change of attention [ Time Frame: change in baseline ADHD rating scale at 16weeks ]
    ADHD rating scale; total 18 questions. Each item is scored from 0-3 points, The treatment effect is evaluated using Total score(0 ~ 54 points),attention-deficit scores (0 ~ 27 points) and hyperactivity/impulsivity score (0 ~ 27 points)

  10. change of attention [ Time Frame: change in baseline self-esteem at 16weeks ]
    Self-Esteem Scale; total 10 question, Each item is scored from 1-4 points. Five of the ten questions are positive and five are negative. In the positive item, 1 = 'almost not so' and 4 = 'always'. In the negative item, the scores range from 10 to 40. The treatment effect is evaluated using the total score.

  11. change of attention [ Time Frame: change in baseline quality life of child at 16weeks ]
    PedsQL 4.0; total 23 questions; Each item is scored from 0-4 points, the scores range from 0 to 2300, higher values represent a better outcome

  12. change of attention [ Time Frame: change in baseline attention at 16weeks ]
    Continuous Performance Test 3rd edition; It is a computerized assessment tool designed to measure attention-related problems, instructing them to respond to all stimuli except alphabet X, and instructing them to perform as accurately and quickly as possible. Detectability, Omission Errors, Commission Errors, Perseverations, HRT(hit reaction time), HRT SD (standard deviation), Variability, HRT Block Change, HRT ISI Change are used to assess respondents' performance on inattentiveness, impulsivity, sustained attention, and vigilance. It is used 9 T-scores to assess the level of attention problem.

  13. change of attention [ Time Frame: change in baseline Quantitative electroencephalography at 16weeks ]
    Quantitative electroencephalography; using Neuroscan Synamp2 amplifier(Compumedics USA, El Paso, TX, USA); EEG is measured in the closed eye state and the GO / NOGO task state respectively. For quantitative analysis, EEG without a handwriting is digitized by Fast Fourier Transformation. The square root of the magnitude of the EEG was calculated as the microvolt (uV) value, and the relative power is defined as the electrical force of the specific region divided by the electrical force in the whole region. The relative power of delta, theta, alpha, and beta waves and theta / beta ratio measured at the Cz electrode are used for the analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of spastic CP
  • GMFCS level I-III
  • weight < 35kg
  • ability to walk independently with or without an assistive device
  • ability to comply with the study protocol and follow verbal directions

Exclusion Criteria:

  • botulinum toxin injection within 3 months
  • orthopedic surgery within 1 year
  • moderate to severe intellectual disability
  • uncontrolled seizure
  • poor visual or hearing acuity Families of the participants were advised about the study, including the risks and benefits, before giving written consent. Approval for this study was obtained from the Institutional Review Board of the Samsung Medical Center, Korea
  • Patients who weigh more than 35 kg, uncontrolled seizures, visual disturbances, hearing impairments, intellectual disabilities, difficulty performing one step instructions, hip dislocation, scoliosis more than 30 degrees, musculoskeletal surgery within 1 year, Injection of botulinum toxin within 3 months or other medical reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870893


Contacts
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Contact: Jeongyi Kwon, Professor 82-10-4591-1039 pedsrehab@gmail.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: JEONG-YI KWON, MD, PHD    +8210-4591-1039    jeongyi.kwon@samsung.com   
Principal Investigator: JEONG-YI KWON, MD         
Sponsors and Collaborators
Samsung Medical Center
National Research Foundation of Korea
Investigators
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Principal Investigator: Minhwa Suk Researcher

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Responsible Party: Jeong Yi Kwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03870893     History of Changes
Other Study ID Numbers: 2017-0665-000
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeong Yi Kwon, Samsung Medical Center:
cerebral palsy
hippotherapy
cardiopulmonary fitness
physical activity
attention
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Cognition Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders