Trial Outcomes & Findings for Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy (NCT NCT03870893)
NCT ID: NCT03870893
Last Updated: 2020-08-05
Results Overview
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.
COMPLETED
NA
47 participants
Change in baseline CGI at 16weeks
2020-08-05
Participant Flow
Participant milestones
| Measure |
Intervention Group
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
No intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy
Baseline characteristics by cohort
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.74 years
STANDARD_DEVIATION 1.63 • n=5 Participants
|
7.22 years
STANDARD_DEVIATION 1.48 • n=7 Participants
|
7.48 years
STANDARD_DEVIATION 1.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in baseline CGI at 16weeksThe 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.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Clinical Global Improvement(CGI)
Change of CGI-S
|
-0.13 score on a scale
Standard Deviation 0.46
|
-0.09 score on a scale
Standard Deviation 0.29
|
|
Change of Clinical Global Improvement(CGI)
Change of CGI-I
|
2.65 score on a scale
Standard Deviation 0.78
|
3.87 score on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Change in baseline attention at 16weeksChild 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.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Attention
Total problems(pre)
|
57.52 T-score
Standard Deviation 9.08
|
57.70 T-score
Standard Deviation 7.15
|
|
Change of Attention
Total problems(post)
|
54.61 T-score
Standard Deviation 11.63
|
55.39 T-score
Standard Deviation 7.55
|
SECONDARY outcome
Timeframe: Change in baseline physical activity at 16weeksThe %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).
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Physical Activity(%)
Change of %SPA
|
1.86 percentage of physcal activity
Standard Deviation 5.07
|
-0.61 percentage of physcal activity
Standard Deviation 4.86
|
|
Change of Physical Activity(%)
Change of %LPA
|
-1.58 percentage of physcal activity
Standard Deviation 4.41
|
0.24 percentage of physcal activity
Standard Deviation 3.74
|
|
Change of Physical Activity(%)
Change of %MPA
|
-0.28 percentage of physcal activity
Standard Deviation 0.67
|
0.13 percentage of physcal activity
Standard Deviation 1.00
|
|
Change of Physical Activity(%)
Change of %VPA
|
0.00 percentage of physcal activity
Standard Deviation 0.53
|
0.25 percentage of physcal activity
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Change in baseline peak oxygen uptake at 16weeksPopulation: Five Participants want to stop during measurement (Intervention group -\> 3 participants; Control group -\> 2 participants)
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.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=21 Participants
No intervention
|
|---|---|---|
|
Change of Peak Oxygen Uptake(VO2peak)
|
1.84 ml/kg/min
Standard Deviation 4.33
|
-0.09 ml/kg/min
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: Change in baseline Gross Motor Function Measure 66 at 16weeksGMFM-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.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Gross Motor Function Measure 66
|
2.24 scores on a scale
Standard Deviation 2.32
|
0.81 scores on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Change in baseline steps at 16weeksSteps(counts) was measured during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA)
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Physical Activity(Steps)
|
-37.97 step counts per minute
Standard Deviation 140.50
|
20.94 step counts per minute
Standard Deviation 180.53
|
SECONDARY outcome
Timeframe: Change in baseline resting heart rate at 16weeksPopulation: Participants want to stop during measurement (Intervention group -\> 3 participants; Control group -\> 2 participants)
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.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=21 Participants
No intervention
|
|---|---|---|
|
Change of Resting Heart Rate(RHR)
|
-12.40 beats per minute
Standard Deviation 11.98
|
-0.62 beats per minute
Standard Deviation 8.41
|
SECONDARY outcome
Timeframe: Change in baseline respiratory exchange ratio at 16weeksAll 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.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=21 Participants
No intervention
|
|---|---|---|
|
Change of Respiratory Exchange Ratio(RER)
|
0.04 Ratio
Standard Deviation 0.05
|
0.01 Ratio
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: Change in baseline heart rate recovery at 16weeksAll 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.
Outcome measures
| Measure |
Intervention Group
n=13 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=13 Participants
No intervention
|
|---|---|---|
|
Change of Heart Rate Recovery(HRR)
Change of heart rate recovery 1
|
6.54 beats per minute
Standard Deviation 6.34
|
-2.15 beats per minute
Standard Deviation 5.20
|
|
Change of Heart Rate Recovery(HRR)
Change of heart rate recovery3
|
13.38 beats per minute
Standard Deviation 12.92
|
-5.54 beats per minute
Standard Deviation 5.81
|
|
Change of Heart Rate Recovery(HRR)
Change of heart rate recovery5
|
11.15 beats per minute
Standard Deviation 11.42
|
-3.80 beats per minute
Standard Deviation 7.07
|
SECONDARY outcome
Timeframe: Change in baseline child health questionnaire-parent form 50 at 16weeksThe 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).
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Children Health Questionnaire Parent Form 50 (CHQ-PF50)
Summary score(Physical)
|
2.73 score on a scale
Standard Deviation 7.42
|
2.08 score on a scale
Standard Deviation 7.78
|
|
Change of Children Health Questionnaire Parent Form 50 (CHQ-PF50)
Summary score(Psychosocial)
|
3.31 score on a scale
Standard Deviation 7.78
|
2.50 score on a scale
Standard Deviation 6.65
|
SECONDARY outcome
Timeframe: Change in baseline timed up and go at 16weeks① 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.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Timed up and go(TUG)
|
-1.55 seconds
Standard Deviation 1.19
|
-1.33 seconds
Standard Deviation 3.64
|
SECONDARY outcome
Timeframe: Change in baseline 6 minute walk test at 16weeksThe 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.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of 6 Minute Walk Test(6MWT)
|
37.22 meters
Standard Deviation 49.52
|
13.43 meters
Standard Deviation 37.47
|
SECONDARY outcome
Timeframe: Change in baseline blood pressure at 16weeksBlood pressure(mmHg) measured before graded exercise test using treadmill.
Outcome measures
| Measure |
Intervention Group
n=20 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=21 Participants
No intervention
|
|---|---|---|
|
Change of Blood Pressure(BP)
Change of SBP
|
-1.30 mmHg
Standard Deviation 7.03
|
0.05 mmHg
Standard Deviation 6.29
|
|
Change of Blood Pressure(BP)
Change of DBP
|
-1.55 mmHg
Standard Deviation 8.22
|
0.52 mmHg
Standard Deviation 7.73
|
SECONDARY outcome
Timeframe: Change in baseline pediatric balance scale at 16weeksPBS 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.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Pediatric Balance Scale(PBS)
|
2.48 score on a scale
Standard Deviation 2.00
|
0.30 score on a scale
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Change in baseline ADHD rating scale at 16weeksADHD(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)
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale
Total score(pre)
|
12.22 score on a scale
Standard Deviation 8.66
|
11.13 score on a scale
Standard Deviation 8.32
|
|
Change of Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale
Total score(post)
|
11.17 score on a scale
Standard Deviation 8.32
|
10.26 score on a scale
Standard Deviation 8.20
|
SECONDARY outcome
Timeframe: Change in baseline self-esteem at 16weeksSelf-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.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Self-Esteem Scale
Pre-test outcome
|
31.22 score on a scale
Standard Deviation 4.34
|
32.48 score on a scale
Standard Deviation 2.81
|
|
Change of Self-Esteem Scale
Post-test outcome
|
32.35 score on a scale
Standard Deviation 3.61
|
33.34 score on a scale
Standard Deviation 3.72
|
SECONDARY outcome
Timeframe: Change in baseline quality life of child at 16weeksPedsQL 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.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of PedsQL 4.0
School functioning(post)
|
74.13 score on a scale
Standard Deviation 18.99
|
85.44 score on a scale
Standard Deviation 12.33
|
|
Change of PedsQL 4.0
Physical functioning(pre)
|
60.73 score on a scale
Standard Deviation 19.21
|
65.90 score on a scale
Standard Deviation 18.15
|
|
Change of PedsQL 4.0
Physical functioning(post)
|
69.70 score on a scale
Standard Deviation 15.81
|
77.85 score on a scale
Standard Deviation 15.10
|
|
Change of PedsQL 4.0
Emotional functioning(pre)
|
70.22 score on a scale
Standard Deviation 24.84
|
69.57 score on a scale
Standard Deviation 27.67
|
|
Change of PedsQL 4.0
Emotional functioning(post)
|
79.13 score on a scale
Standard Deviation 20.49
|
82.17 score on a scale
Standard Deviation 16.98
|
|
Change of PedsQL 4.0
Social functioning(pre)
|
58.48 score on a scale
Standard Deviation 28.14
|
61.30 score on a scale
Standard Deviation 27019
|
|
Change of PedsQL 4.0
Social functioning(post)
|
74.13 score on a scale
Standard Deviation 16.90
|
80.65 score on a scale
Standard Deviation 22.02
|
|
Change of PedsQL 4.0
School functioning(pre)
|
69.35 score on a scale
Standard Deviation 22.98
|
72.39 score on a scale
Standard Deviation 24.67
|
SECONDARY outcome
Timeframe: Change in baseline attention at 16weeksContinuous 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.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Continuous Performance Test 3rd Edition
detectability(pre)
|
59.00 T-scores
Standard Deviation 7.62
|
54.00 T-scores
Standard Deviation 7.76
|
|
Change of Continuous Performance Test 3rd Edition
detectability(post)
|
52.57 T-scores
Standard Deviation 10.23
|
49.61 T-scores
Standard Deviation 8.11
|
|
Change of Continuous Performance Test 3rd Edition
Omissions(pre)
|
71.70 T-scores
Standard Deviation 16.66
|
59.91 T-scores
Standard Deviation 11.29
|
|
Change of Continuous Performance Test 3rd Edition
Omissions(post)
|
67.13 T-scores
Standard Deviation 18.61
|
57.91 T-scores
Standard Deviation 14.84
|
|
Change of Continuous Performance Test 3rd Edition
Commisions(pre)
|
48.74 T-scores
Standard Deviation 9.90
|
46.65 T-scores
Standard Deviation 9.47
|
|
Change of Continuous Performance Test 3rd Edition
Commisions(post)
|
42.96 T-scores
Standard Deviation 7.50
|
43.13 T-scores
Standard Deviation 7.24
|
|
Change of Continuous Performance Test 3rd Edition
Perseveration(pre)
|
61.30 T-scores
Standard Deviation 13.65
|
51.57 T-scores
Standard Deviation 8.77
|
|
Change of Continuous Performance Test 3rd Edition
Perseveration(post)
|
53.04 T-scores
Standard Deviation 8.22
|
49.91 T-scores
Standard Deviation 6.82
|
|
Change of Continuous Performance Test 3rd Edition
hit reaction time(pre)
|
69.87 T-scores
Standard Deviation 14.75
|
65.04 T-scores
Standard Deviation 11.31
|
|
Change of Continuous Performance Test 3rd Edition
hit reaction time(post)
|
70.04 T-scores
Standard Deviation 14.22
|
65.70 T-scores
Standard Deviation 12.31
|
|
Change of Continuous Performance Test 3rd Edition
standard deviation of hit reaction time(pre)
|
65.74 T-scores
Standard Deviation 12.08
|
55.83 T-scores
Standard Deviation 10.18
|
|
Change of Continuous Performance Test 3rd Edition
standard deviation of hit reaction time(post)
|
60.78 T-scores
Standard Deviation 12.14
|
55.04 T-scores
Standard Deviation 9.77
|
SECONDARY outcome
Timeframe: Change in baseline Quantitative electroencephalography at 16weeksAn 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.
Outcome measures
| Measure |
Intervention Group
n=23 Participants
Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).
|
Control Group
n=23 Participants
No intervention
|
|---|---|---|
|
Change of Quantitative Electroencephalography
Fz(pre)
|
0.384 Z-score
Standard Deviation 0.961
|
-0.046 Z-score
Standard Deviation 0.910
|
|
Change of Quantitative Electroencephalography
Fz(post)
|
0.522 Z-score
Standard Deviation 0.835
|
-0.098 Z-score
Standard Deviation 0.826
|
|
Change of Quantitative Electroencephalography
Cz(pre)
|
0.501 Z-score
Standard Deviation 1.420
|
0.058 Z-score
Standard Deviation 0.883
|
|
Change of Quantitative Electroencephalography
Cz(post)
|
0.274 Z-score
Standard Deviation 0.933
|
0.342 Z-score
Standard Deviation 0.760
|
|
Change of Quantitative Electroencephalography
Pz(pre)
|
0.077 Z-score
Standard Deviation 0.857
|
-0.130 Z-score
Standard Deviation 0.980
|
|
Change of Quantitative Electroencephalography
Pz(post)
|
0.240 Z-score
Standard Deviation 1.141
|
-0.156 Z-score
Standard Deviation 0.730
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place