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Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects

Primary Purpose

Cancer, Child, Only, Child Behavior

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Horse-Assisted Rehabilitation
Sponsored by
Escoles Universitaries Gimbernat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Child Behavior, Neurologic Gait Disorder, Cancer, Physical Therapy Modalities, Physical Therapy Specialty, Physical and Rehabilitation Medicine, Rehabilitation

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children between 4 and 18 years of age, who had suffered a cancer with affectation of the Central Nervous System
  • With or without motor, functional and / or cognitive deficits or neurological disorders due to their basic problem or be as a consequence of the therapeutic procedures, with any degree of disability
  • More than 6 months after receiving the discharge of oncology (chemotherapy or radiotherapy)

Exclusion Criteria:

  • Immunodepression
  • Hypotonia with severe pelvic instability that does not allow seating on the horse safely
  • Weight greater than 80Kg.
  • Phobia to horses

Sites / Locations

  • Hospital Universitari de Sant Joan de Déu
  • Hospital Universitari Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

Regular follow ups.

One weekly session (1 hour) of Horse-Assisted Rehabilitation, 24 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
General Health Status Changes
Barcelona General Health Status Questionnaire 2000 (sections: C, D, E, F, K, L, M; qualitative questionnaire, no total score).
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).
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.
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).
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)
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)
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)
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)
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)
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)
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).
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).
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).
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).

Full Information

First Posted
August 21, 2019
Last Updated
March 22, 2022
Sponsor
Escoles Universitaries Gimbernat
Collaborators
Hospital Vall d'Hebron, Hospital Sant Joan de Deu
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1. Study Identification

Unique Protocol Identification Number
NCT04070131
Brief Title
Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects
Official Title
Rehabilitació Assistida Amb Cavalls Posttractament oncològic en Nens i Adolescents: Efectes físics i psicològics
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Escoles Universitaries Gimbernat
Collaborators
Hospital Vall d'Hebron, Hospital Sant Joan de Deu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Child, Only, Child Behavior, Neurologic Gait Disorder, Neurologic Complication
Keywords
Child Behavior, Neurologic Gait Disorder, Cancer, Physical Therapy Modalities, Physical Therapy Specialty, Physical and Rehabilitation Medicine, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Controlled parallel clinical trial, randomised, not-masked, with Control Group and Intervention Group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Regular follow ups.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
One weekly session (1 hour) of Horse-Assisted Rehabilitation, 24 weeks.
Intervention Type
Other
Intervention Name(s)
Horse-Assisted Rehabilitation
Other Intervention Name(s)
Equine-Assisted Rehabilitation, Hippotherapy
Intervention Description
One hour weelky session of hippotherapy.
Primary Outcome Measure Information:
Title
Self-Reported Quality Of Life Changes
Description
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
Secondary Outcome Measure Information:
Title
Parent-Proxys Reported Quality Of Life Changes
Description
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
Title
General Health Status Changes
Description
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
Title
Anxiety Changes
Description
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
Title
Depression Changes
Description
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
Title
Behavior Changes
Description
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
Title
Self-Reported Physical Function Changes
Description
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
Title
Parents-Reported Physical Function Changes
Description
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
Title
Self-Reported Emotional Function Changes
Description
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
Title
Parent-Reported Emotional Function Changes
Description
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
Title
Self-Reported Sociability Function Changes
Description
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
Title
Parent-Reported Sociability Function Changes
Description
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
Title
Balance Changes
Description
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
Title
Position Changes
Description
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
Title
Proprioception-Coordination Changes
Description
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
Title
Autonomous Neurvous System activation function Changes
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children between 4 and 18 years of age, who had suffered a cancer with affectation of the Central Nervous System With or without motor, functional and / or cognitive deficits or neurological disorders due to their basic problem or be as a consequence of the therapeutic procedures, with any degree of disability More than 6 months after receiving the discharge of oncology (chemotherapy or radiotherapy) Exclusion Criteria: Immunodepression Hypotonia with severe pelvic instability that does not allow seating on the horse safely Weight greater than 80Kg. Phobia to horses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordi Esquirol Caussa, PhD, MD
Organizational Affiliation
Escoles Universitàries Gimbernat
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Teresa Xipell Prunés, PT
Organizational Affiliation
Escoles Universitàries Gimbernat
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari de Sant Joan de Déu
City
Esplugues De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects

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