NCT03629821

Brief Summary

Is a parallel longitudinal protocol where half patients receive a experimental protocol and the other half receive orientation to maintain your daily live routine as usually. The experimental protocol include Ballet sessions. The hypothesis is interventional group will improve the balance control more than control group.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

June 11, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

June 11, 2018

Last Update Submit

November 4, 2020

Conditions

Keywords

Postural BalanceDance TherapyExercise Therapy

Outcome Measures

Primary Outcomes (8)

  • Change from baseline in total score of Star Excursion Balance Test at 8 weeks.

    Changing between the beginning and end of intervention. This measure is shown in cm.

    Before, immediate after intervention protocol

  • Change from baseline in anteriorposterior and mediolateral displacements of Pressure Center at 8 weeks.

    Changing between the beginning and end of intervention of anteroposterior and mediolateral displacements of pressure center in cm.

    Before, immediate after intervention protocol

  • Change from baseline in average speed of Pressure Center at 8 weeks.

    Changing between the beginning and end of average speed of pressure center in cm/s.

    Before, immediate after intervention protocol

  • Change from baseline in 95% ellipse area of Pressure Center at 8 weeks.

    Changing between the beginning and end of 95% ellipse area of pressure center in cm².

    Before, immediate after intervention protocol

  • Maintenance at 30 and 60 days from baseline in total score of Star Excursion Balance Test.

    Changing between the end and 30 and 60 days after intervention. This measure is shown in cm.

    Immediate after, 30 and 60 days after intervention protocol.

  • Maintenance at 30 and 60 days from baseline in anteroposterior and mediolateral displacements of pressure center

    Changing between the end and 30 and 60 days after intervention of anteroposterior and mediolateral displacements of pressure center in cm.

    Immediate after, 30 and 60 days after intervention protocol.

  • Maintenance at 30 and 60 days from baseline in average speed of pressure center

    Changing between the end and 30 and 60 days after intervention of average speed of pressure center in cm/s.

    Immediate after, 30 and 60 days after intervention protocol.

  • Maintenance at 30 and 60 days from baseline in 95% ellipse area of pressure center

    Changing between the end and 30 and 60 days after intervention of 95% ellipse area of pressure center in cm².

    Immediate after, 30 and 60 days after intervention protocol.

Secondary Outcomes (2)

  • Vertical stiffness

    Before, immediate after, 30 and 60 days after intervention protocol

  • Peak and absortion rate of ground reaction force

    Before, immediate after, 30 and 60 days after intervention protocol

Other Outcomes (1)

  • Physical activity level

    Before intervention

Study Arms (2)

Ballet

EXPERIMENTAL

Subjects who will receive the experimental protocol.

Other: Ballet

Control

NO INTERVENTION

Subjects who will not receive the experimental protocol, only will be on a wait list.

Interventions

BalletOTHER

The classic ballet classes will respect biological limits of children. The sessions will be 75 minutes long, twice a week during 8 weeks. The class sequence will be: warm-up, follow by exercises about upper and lower limbs ballet positions and sequences of ballet jumps, and at the end a cool-down.

Ballet

Eligibility Criteria

Age9 Years - 12 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Female sex
  • to 12 years of age

You may not qualify if:

  • Musculoskeletal pain at last 3 months
  • Perform other physical activity besides scholar's physical activity
  • Has been participated Ballet class.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kelen Munhos Pinto

Santa Maria, Rio Grande do Sul, 97105900, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups design where one group receives treatment and the other not in the same period of time.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2018

First Posted

August 14, 2018

Study Start

July 15, 2018

Primary Completion

October 30, 2018

Study Completion

November 30, 2022

Last Updated

November 6, 2020

Record last verified: 2020-11

Locations