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Recruiting NCT07166055

Effect of Dance on the Parameters of the ICF in Children With Functional Diversity

No phase Interventional Children With Disabilities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Therapeutic dance.
Who it may be relevant to
Registry conditions: Children With Disabilities. Basic parameters: 3 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Therapeutic Dance on the Parameters of the International Classification of Functioning, Disability, and Health in Children With Functional Diversity

Overview

The goal of this clinical trial is to determine the effect of a therapeutic dance program developed in a school environment on different parameters of structure and function, activity and participation according to the ICF framework in children with functional diversity. Researchers will compare the effects of eight months of therapeutic dance classes (consisting of two one-hour sessions per week) on ICF parameters to the effects of no intervention.

Detailed description

This randomized clinical trial is designed to determine the effect of therapeutic dance developed in a school environment on different parameters of structure, function, activity, and participation according to the ICF framework in children with functional diversity. The study will include around 30 participants between the ages of 3 and 14.

Participants will be selected from five collaborating educational centers. Participants will be selected after an interview with teachers and after meeting the inclusion criteria. All families must sign an informed consent form allowing their child to participate. Each educational center will be randomly assigned to the intervention or control group.

The protocol includes two sessions per week from October to May. Each session lasts one hour. There will be two evaluations: one before the intervention begins and one at the end of the protocol. The primary outcomes include motor function, balance, walking speed, quality of life as perceived by patients and caregivers, and participation in daily activities.

This study adheres to the CONSORT guidelines and the Declaration of Helsinki, and it has been reviewed by an ethics committee.

Interventions

  • Other Therapeutic dance
    The protocol includes two sessions per week of therapeutic dance, during the months of October to May.

Primary outcome measures

  • The Canadian Occupational Performance Measure (COPM). [Time frame: Baseline (pre-intervention) and immediately post-intervention.]
  • Goal Attainment Scale (GAS). [Time frame: Baseline (pre-intervention) and immediately post-intervention.]
Secondary outcome measures (5)
  • Quality of life with the Pediatric Quality of Life Inventory (PEDS QL) [Time frame: Baseline (pre-intervention) and immediately post-intervention.]
  • Gross Motor Function Measure (GMFM-88). [Time frame: Baseline (pre-intervention) and immediately post-intervention.]
  • Pediatric Balance Scale [Time frame: Baseline (pre-intervention) and immediately post-intervention.]
  • Timed up and go test (TUG) [Time frame: Baseline (pre-intervention) and immediately post-intervention.]
  • Joint ranges [Time frame: Baseline (pre-intervention) and immediately post-intervention.]

Eligibility criteria

Inclusion criteria

  • children with motor impairment
  • aged between 3-14 years,
  • who can cognitively follow simple tasks

Exclusion criteria

  • having suffered a serious clinical condition or surgical intervention in the last 6 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • University of Valencia — Valencia

Identifiers

NCT: NCT07166055 · 2024-FIS-3495976

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗