跳至主要内容
临床试验/NCT07166055
NCT07166055招募中不适用

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

University of Valencia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
The Canadian Occupational Performance Measure (COPM).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The researcher in charge of the statistical analysis is blinded.

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Dance group

Experimental

Paticipants in this group will perform eight months of therapeutic dance classes (consisting of two one-hour sessions per week).

干预措施: Therapeutic dance (Other)

Control group

No Intervention

Participants in this group will continue their usual activities.

结局指标

主要结局

The Canadian Occupational Performance Measure (COPM).

时间窗: Baseline (pre-intervention) and immediately post-intervention.

Is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.

Goal Attainment Scale (GAS).

时间窗: Baseline (pre-intervention) and immediately post-intervention.

Goal Attainment Scaling (GAS) is a method of scoring the extent to which patient's individual goals are achieved in the course of intervention.

次要结局

  • Gross Motor Function Measure (GMFM-88).(Baseline (pre-intervention) and immediately post-intervention.)
  • Joint ranges(Baseline (pre-intervention) and immediately post-intervention.)
  • Quality of life with the Pediatric Quality of Life Inventory (PEDS QL)(Baseline (pre-intervention) and immediately post-intervention.)
  • Pediatric Balance Scale(Baseline (pre-intervention) and immediately post-intervention.)
  • Timed up and go test (TUG)(Baseline (pre-intervention) and immediately post-intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

M Luz Sanchez

Professor

University of Valencia

研究点 (1)

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