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Clinical Trials/NCT04070131
NCT04070131
Unknown
Not Applicable

Rehabilitació Assistida Amb Cavalls Posttractament oncològic en Nens i Adolescents: Efectes físics i psicològics

Escoles Universitaries Gimbernat2 sites in 1 country30 target enrollmentOctober 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Escoles Universitaries Gimbernat
Enrollment
30
Locations
2
Primary Endpoint
Self-Reported Quality Of Life Changes
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2019
End Date
June 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Escoles Universitaries Gimbernat
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Self-Reported Quality Of Life Changes

Time Frame: Baseline and 25th week

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 Outcomes

  • Anxiety Changes(Baseline and 25th week)
  • Depression Changes(Baseline and 25th week)
  • Self-Reported Sociability Function Changes(Baseline and 25th week)
  • Self-Reported Physical Function Changes(Baseline and 25th week)
  • Behavior Changes(Baseline and 25th week)
  • Parents-Reported Physical Function Changes(Baseline and 25th week)
  • Self-Reported Emotional Function Changes(Baseline and 25th week)
  • Parent-Proxys Reported Quality Of Life Changes(Baseline and 25th week)
  • General Health Status Changes(Baseline and 25th week)
  • Parent-Reported Emotional Function Changes(Baseline and 25th week)
  • Balance Changes(Baseline, 6th, 12th and 25th week)
  • Proprioception-Coordination Changes(Baseline and 25th week)
  • Autonomous Neurvous System activation function Changes(Baseline, 6th, 12th and 25th week)
  • Parent-Reported Sociability Function Changes(Baseline and 25th week)
  • Position Changes(Baseline, 6th, 12th and 25th week)

Study Sites (2)

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