NCT06648408

Brief Summary

This study looks at how ballet training affects movement and personal feelings in children with a condition called idiopathic coxa antetorta.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

October 14, 2024

Last Update Submit

December 6, 2024

Conditions

Keywords

Increased femoral anteversion (IFA)Idiopathic coxa antetortaChildhood knee painPhysical activity interventionBallet training for childrenHip strength and mobilityKnee flexion in childrenExercise for hip flexibilityIn-toeing gait in children

Outcome Measures

Primary Outcomes (2)

  • Kinematic measurement and

    This study will track knee flexion during the mid-stance phase of walking, as children with coxa antetorta often show increased knee bending, which can lead to future knee issues. The children's walking will be recorded using a 2D gait analysis system on the C-Mill treadmill, offering accurate results while minimizing stress and reducing the chance of errors.

    Week1 and week 8

  • Subjective functional mobility

    The children's mobility and quality of life will be assessed, using the parent-reported Pediatric Outcomes Data Collection Instrument (PODCI), a reliable questionnaire designed for children with musculoskeletal conditions. It measures various aspects of daily functioning and well-being, and the scores range from 0 to 100, with lower scores indicating more difficulties.

    Week1 and week 8

Secondary Outcomes (5)

  • Gait Analysis

    Week1 and week 8

  • Measurement of femoral anteversion angle (°)

    Week1 and week 8

  • Measurement of hip strength (N)

    Week1 and week 8

  • Measurement of hip mobility (°)

    Week1 and week 8

  • Feasibility assessment

    Week 8

Study Arms (2)

Ballet training

EXPERIMENTAL

The children in this arm of the study will receive ballet training.

Procedure: Balett Training

Control group

NO INTERVENTION

The children in the control group in this study will not receive any intervention, according to the German guidelines for idiopathic coxa antetorta 2002. This is in line with the standard approach, as children in this developmental phase typically do not receive therapy for this condition.

Interventions

The ballet training will happen twice a week for six weeks, with each session lasting 60 minutes, for a total of 12 sessions. These sessions will be held in groups of 10 to 12 children and led by experienced ballet teachers. The classes will follow a beginner-level ballet routine, introducing the kids to ballet techniques in a fun and playful way, making sure they learn the movements step by step. Each lesson will follow the same structure, allowing the children to improve their skills week after week. In addition to the group sessions, the children will be given a 10-minute daily home exercise program. This will include simple ballet exercises they learned in their first class, which they should practice on the five days when they don't have ballet sessions. The children will track their practice in a child-friendly diary designed just for them.

Ballet training

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of idiopathic coxa antetorta with FNA\> 30°
  • Children between 8 and 12 years of age
  • Cognitive abilities must include: Ability to actively participate in a 60-minute ballet class; Ability to communicate pain or discomfort; Ability to attend training, testing and follow-up sessions. All included participants can make decisions on their own and do not show any signs of mental or cognitive limitations.

You may not qualify if:

  • Any surgery within 6 months prior to the start of the study or surgery scheduled during the study period. Other medications can be continued as prescribed by the participants' physician
  • Known cardiovascular or pulmonary diseases that have not received medical clearance to participate in the physical exercise intervention
  • Neurological or other musculoskeletal comorbidities
  • The children should not have completed any ballet training in the last 12 months
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäts-Kinderspital beider Basel (UKBB)

Basel, 4031, Switzerland

RECRUITING

Study Officials

  • Michèle Widmer, Dr. med.

    Universitäts-Kinderspital beider Basel (UKBB)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michèle Widmer, Dr. med.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 18, 2024

Study Start

August 8, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations