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Cerebral PalsyNCT03870893

Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy

A study testing hippotherapy in people with Cerebral Palsy and Physical Activity, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 years
What is being tested?
hippotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteSouth Korea
Study dates
5 Jul 2017to 28 Feb 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • botulinum toxin injection within 3 months
  • orthopedic surgery within 1 year (difficulty performing one step instructions)
  • moderate to severe intellectual disability
  • uncontrolled seizure
  • poor visual or hearing acuity
  • patients who weigh more than 35 kg
Show all 9Show fewer
  • hip dislocation
  • scoliosis more than 30 degrees
  • musculoskeletal surgery within 1 year

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: Effects of Hippotherapy on Physical Activities, Cardiopulmonary Fitness and Attention in Children With Cerebral Palsy

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.

Read the 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.

Being tested
hippotherapy
Keywords
cerebral palsy, hippotherapy, cardiopulmonary fitness, physical activity, attention
Medical subject headings
Cerebral Palsy, Motor Activity, Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hippotherapyBehavioural

    16weeks hippotherapy program

Study groups in NCT03870893
Study groupRoleWhat they receive
Intervention groupExperimentalIntervention is administered to patients in this Arm.
Receives: Behavioral: hippotherapy
control groupNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Clinical Global Improvement(CGI)

    The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Lower values represent a better outcome.

    The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as 1= very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Higher values represent a better outcome.

    Measured: Change in baseline CGI at 16weeks

Secondary outcomes (18)
  1. Change of Attention

    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.

    Measured: Change in baseline attention at 16weeks

  2. Change of Physical Activity(%)

    The %sedentary physical activity(%SPA), %light physical activity(%LPA), %moderate physical activity(%MPA), %vigorous physical activity(%VPA) during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA).

    Measured: Change in baseline physical activity at 16weeks

  3. Change of Peak Oxygen Uptake(VO2peak)

    peak oxygen uptake(ml/kg/min) is a category of physical fitness, which is measured during graded submaximal exercise test. Higher values represent a better outcome.

    Measured: Change in baseline peak oxygen uptake at 16weeks

  4. Change of Gross Motor Function Measure 66

    GMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. The score of each dimension is expressed as a percentage of the maximum score. The GMFM-66, which includes 66 items of the original 88 items. Item scoring is the same for the GMFM-88 and the GMFM-66. There is a scoring system with each item scored as 0, 1, 2, 3, or "not tested". A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. Scoring the GMFM-66 requires the use of a computer program called the Gross Motor Ability Estimator (GMAE). Individual item scores are entered and a mathematical algorithm calculates an interval level total score. The total score is an estimate of the child's gross motor function. The range of total score in GMFM-66 is from 0 to 100. The range of % in GMFM-88 is from 0 to 100. Higher values represent a better outcome.

    Measured: Change in baseline Gross Motor Function Measure 66 at 16weeks

  5. Change of Physical Activity(Steps)

    Steps(counts) was measured during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA)

    Measured: Change in baseline steps at 16weeks

  6. Change of Resting Heart Rate(RHR)

    Resting heart rate(beats/min) is a category of physical fitness, which is measured during graded submaximal exercise test. A normal resting heart rate for adults ranges from 60 to 100 beats per minute. Generally, a lower heart rate at rest implies more efficient heart function and better cardiovascular fitness.

    Measured: Change in baseline resting heart rate at 16weeks

  7. Change of Respiratory Exchange Ratio(RER)

    All patients performed a symptom-limited, treadmill exercise test using the Modified Naughton protocol. Respiratory exchange ratio(RER) were measured with a gas analyzer. RER is the ratio between the amount of carbon dioxide (CO2) produced in metabolism and oxygen (O2) used. A high RER (RER values≥1) indicates that carbohydrates are being predominantly used, whereas a low RER (RER values<1) suggests lipid oxidation.

    Measured: Change in baseline respiratory exchange ratio at 16weeks

  8. Change of Heart Rate Recovery(HRR)

    All patients performed a symptom-limited, treadmill exercise test using the Modified Naughton protocol. In the recovery period, the patients walked for 2 minutes at a speed of 1.9 km/h and a grade of 0% and then sat down in a chair for the last 3 minutes (recovery). The Heart rate recovery (HRR) was defined as the difference between peak HR during the test and HR at 1 (HRR1), 3 (HRR3), and 5 (HRR5) minutes.

    Measured: Change in baseline heart rate recovery at 16weeks

  9. Change of Children Health Questionnaire Parent Form 50 (CHQ-PF50)

    The Child Health Questionnaire™ (CHQ) is a family of generic person-reported outcomes measures to assess health-related quality of life for children and adolescents from 5-to-18 years of age. 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. Scores can be analyzed at combined to derive an overall physical and psychosocial score, (CHQ Summary Scores).

    Measured: Change in baseline child health questionnaire-parent form 50 at 16weeks

  10. Change of Timed up and go(TUG)

    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. Lower values represent a better outcome.

    Measured: Change in baseline timed up and go at 16weeks

  11. Change of 6 Minute Walk Test(6MWT)

    The 6 minute walk test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity and endurance. Higher values represent a better outcome.

    Measured: Change in baseline 6 minute walk test at 16weeks

  12. Change of Blood Pressure(BP)

    Blood pressure(mmHg) measured before graded exercise test using treadmill.

    Measured: Change in baseline blood pressure at 16weeks

  13. Change of Pediatric Balance Scale(PBS)

    PBS is a functional balance scale adapted and customized from Berg Balance Scale for use with children. The PBS has been used initially to measure the balance functions for school-age children with mild-to-moderate motor impairments. The PBS is a 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks. It can easily be administered and scored in less than 20 minutes using equipment commonly found in schools and clinics. Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. The range of total score is from 0 to 56. Higher values represent a better outcome.

    Measured: Change in baseline pediatric balance scale at 16weeks

  14. Change of Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale

    ADHD(attention deficit hyperactivity disorder) 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)

    Measured: Change in baseline ADHD rating scale at 16weeks

  15. Change of Self-Esteem Scale

    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.

    Measured: Change in baseline self-esteem at 16weeks

  16. Change of PedsQL 4.0

    PedsQL 4.0; total 23 questions; Each item is scored from 0-4 points and scores are transformed on a scale from 0 to 100. Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Thus, the scores range from 0 to 2300, higher values represent a better outcome.

    Measured: Change in baseline quality life of child at 16weeks

  17. Change of Continuous Performance Test 3rd Edition

    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.

    Measured: Change in baseline attention at 16weeks

  18. Change of Quantitative Electroencephalography

    An electroencephalogram (EEG) is a test that detects electrical activity in your brain using small, metal discs(electrodes) attached to your scalp. Your brain cells communicate via electrical impulses and are active all the time. This activity shows up as wave lines on an EEG recording. It is using Neuroscan Synamp2 amplifier(Compumedics USA, El Paso, TX, USA). 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 Fz, Cz, Pz electrode are used for the analysis. The value of theta/beta ratio is average as it approaches 0 and deviates from the mean as it gets away from 0.

    Measured: Change in baseline Quantitative electroencephalography at 16weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2019
  2. Study start5 Jul 2017
  3. Primary completion28 Feb 2020
  4. Study completion28 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03870893
Sponsor's protocol ID
2017-0665-000
Status last verified
Jul 2020
First submitted
26 Jul 2017
Last updated
5 Aug 2020
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Suk MH, Kwon JY. Effect of Equine-Assisted Activities and Therapies on Cardiorespiratory Fitness in Children with Cerebral Palsy: A Randomized Controlled Trial. J Integr Complement Med. 2022 Jan;28(1):51-59. doi: 10.1089/jicm.2021.0158.

    PubMed 35085017
  • Ahn B, Joung YS, Kwon JY, Lee DI, Oh S, Kim BU, Cha JY, Kim JH, Lee JY, Shin HY, Seo YS. Effects of equine-assisted activities on attention and quality of life in children with cerebral palsy in a randomized trial: examining the comorbidity with attention-deficit/hyperactivity disorder. BMC Pediatr. 2021 Mar 19;21(1):135. doi: 10.1186/s12887-021-02597-0.

    PubMed 33740922
  • Park IK, Lee JY, Suk MH, Yoo S, Seo YG, Oh JK, Kwon JY. Effect of Equine-Assisted Activities on Cardiac Autonomic Function in Children with Cerebral Palsy: A Pilot Randomized-Controlled Trial. J Altern Complement Med. 2021 Jan;27(1):96-102. doi: 10.1089/acm.2020.0346. Epub 2020 Nov 27.

    PubMed 33252241

Questions about this trial

What is this clinical trial studying?

A study testing hippotherapy in people with Cerebral Palsy and Physical Activity, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Clinical Global Improvement(CGI) (time frame: Change in baseline CGI at 16weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03870893, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.

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