An interventional study of Horse-Assisted Rehabilitation in Cancer, Child, Only and Child Behavior, sponsored by Escoles Universitaries Gimbernat. Status unknown at 2 sites in Spain. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by Escoles Universitaries Gimbernat · Not applicable, Interventional, and Treatment
Clinical trial on the physical and psychological effects of Horse Assisted Rehabilitation after the treatment of cancer in children 4 to 18 years of age.
Randomized controlled open labelled trial. Duration: 6 months. Groups: Control Group (standard follow-up) and Intervention Group (one weekly rehabilitation session assisted by horse). Participants: 30 children, 4 to 18 years of age, after 6 months of the discharge of the cancer treatment with nervous system involvement.
327 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 246 interventional studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →Escoles Universitaries Gimbernat is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Regular follow ups.
One weekly session (1 hour) of Horse-Assisted Rehabilitation, 24 weeks.
Other: Horse-Assisted Rehabilitation
One hour weelky session of hippotherapy.
Also known as: Equine-Assisted Rehabilitation, Hippotherapy
Self-Reported Quality Of Life Changes
Pediatric Quality of Life Inventory - Child-Self Report (PedsQL-C) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).
Time frame: Baseline and 25th week
Parent-Proxys Reported Quality Of Life Changes
Pediatric Quality of Life Inventory - Parent-Proxy Report (PedsQL-PC) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).
Time frame: Baseline and 25th week
General Health Status Changes
Barcelona General Health Status Questionnaire 2000 (sections: C, D, E, F, K, L, M; qualitative questionnaire, no total score).
Time frame: Baseline and 25th week
Anxiety Changes
State Trait Ansiety IInventory for children (STAI-CH) - norm-referenced scores (T scores and percentile ranks) for each one of the two subscales: Anxiety-Trait \& Anxiety-State (scores 0-60 in each subscale, higher = worse).
Time frame: Baseline and 25th week
Depression Changes
Childhood Depression Inventory (CDI), self report long version (28 items) to assess the presence and severity of depressive symptoms in children. Scores range from 0-56, with higher scores indicating higher levels of depression.
Time frame: Baseline and 25th week
Behavior Changes
Behavior Assessment System for Children - Parent Rating Scale (BASC-PRS), second version (BASC-2) - BASC-2 is parent-reported, well-established scale for externalizing/internalizing problem of children and adolescents. Scoring manual and software is provided by the assessment developers; norm-referenced scores (T scores and percentile ranks) are available in the score reports, as are interpretations of strengths and weaknesses and target behaviors for intervention (mean of 50 and standard deviation of 10; for the behavior problem scales, scores above 60 are considered problematic; for the adaptive scales, scores below 40 are considered problematic).
Time frame: Baseline and 25th week
Self-Reported Physical Function Changes
PedsQL-C (subscale Health and Activities: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Time frame: Baseline and 25th week
Parents-Reported Physical Function Changes
PedsQL-PC (subscale Physical Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Time frame: Baseline and 25th week
Self-Reported Emotional Function Changes
PedsQL-C (subscale Feelings: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Time frame: Baseline and 25th week
Parent-Reported Emotional Function Changes
PedsQL-PC (subscale Emotional Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Time frame: Baseline and 25th week
Self-Reported Sociability Function Changes
PedsQL-C (subscale Get Along with Others: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Time frame: Baseline and 25th week
Parent-Reported Sociability Function Changes
PedsQL-PC (subscale Emotional Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Time frame: Baseline and 25th week
Balance Changes
Pediatric Balance Scale (PBS: 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks; 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 highest score in PBS is 56, higher is better).
Time frame: Baseline, 6th, 12th and 25th week
Position Changes
Sitting Assessment Scale (Sitting Assessment Scale (SAS) is a standardized observational instrument designed for assessment of sitting in children with cerebral palsy (CP); the scale is composed of five items evaluating head, trunk and foot control and arm and hand function, where each item is assessed with a score from 1 to 4 (1 =none; 2=poor; 3=fair; 4=good) and each score (1,2,3,4) has specific decriptors of each item of the SAS).
Time frame: Baseline, 6th, 12th and 25th week
Proprioception-Coordination Changes
Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07: the DCDQ is a brief questionnaire designed to screen for coordination disorders in children, aged 5 to 15 years, and consists of 15 items grouped into three distinct factors (motor control during movement, fine motor and handwriting and general coordination; to reach scores, sum each column to compute the numbers onto the Score Sheet, and add all factor scores to compute a Total Score: 0-75, higher is better).
Time frame: Baseline and 25th week
Autonomous Neurvous System activation function Changes
Heart Rate Variability (HRV, low/high frequency (LH/FH) power ratio; modulation of heart rate variability assessed through analysis of data collected by HRV wireless monitorisation and PolarH7(R) thoracic band (medical device), following the American and European Cardiological Societies).
Time frame: Baseline, 6th, 12th and 25th week
Plan to share: No
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Escoles Universitaries Gimbernat