Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870893
• Other study ID #: 2017-0665-000
• Status: Completed
• Phase: N/A
• Start date: July 5, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: July 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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 (difficulty performing one step instructions)

• moderate to severe intellectual disability

• uncontrolled seizure

• poor visual or hearing acuity

• patients who weigh more than 35 kg

• hip dislocation

• scoliosis more than 30 degrees

• musculoskeletal surgery within 1 year

Related Conditions & MeSH terms

• Attention Disorder
• Cerebral Palsy
• Cognition Disorders
• Paralysis
• Physical Activity

Intervention

Behavioral:
• hippotherapy
16weeks hippotherapy program

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in baseline CGI at 16weeks
Secondary	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.	Change in baseline attention at 16weeks
Secondary	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).	Change in baseline physical activity at 16weeks
Secondary	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.	Change in baseline peak oxygen uptake at 16weeks
Secondary	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.	Change in baseline Gross Motor Function Measure 66 at 16weeks
Secondary	Change of Physical Activity(Steps)	Steps(counts) was measured during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA)	Change in baseline steps at 16weeks
Secondary	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.	Change in baseline resting heart rate at 16weeks
Secondary	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.	Change in baseline respiratory exchange ratio at 16weeks
Secondary	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.	Change in baseline heart rate recovery at 16weeks
Secondary	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).	Change in baseline child health questionnaire-parent form 50 at 16weeks
Secondary	Change of Timed up and go(TUG)	? Stand up from the chair without support. ? Walk 3m from chair. ? Turn around. ? Sit back in the chair. Measure the time(second), higher values represent a worse outcome. Lower values represent a better outcome.	Change in baseline timed up and go at 16weeks
Secondary	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.	Change in baseline 6 minute walk test at 16weeks
Secondary	Change of Blood Pressure(BP)	Blood pressure(mmHg) measured before graded exercise test using treadmill.	Change in baseline blood pressure at 16weeks
Secondary	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.	Change in baseline pediatric balance scale at 16weeks
Secondary	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)	Change in baseline ADHD rating scale at 16weeks
Secondary	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.	Change in baseline self-esteem at 16weeks
Secondary	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.	Change in baseline quality life of child at 16weeks
Secondary	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.	Change in baseline attention at 16weeks
Secondary	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.	Change in baseline Quantitative electroencephalography at 16weeks