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Recruiting

NCT Number: NCT06082739

Managing Kyphosis With Exercise

The primary objective of this study is to determine if stretching exercises as a conservative treatment option will correct kyphosis in postural and Scheuermann's kyphosis.

Recruiting

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Cristabelle Alexander, BS

CONTACT

[email protected]

310-423-1061

David L Skaggs, MD, MMM

PRINCIPAL_INVESTIGATOR

About this study

Despite comprehensive documentation of surgical interventions in existing literature, the investigation into non-operative approaches for addressing hyperkyphosis or Scheuermann's kyphosis in the pediatric population has been investigated with inconsistent findings. Various outcomes have been observed with regard to the effectiveness of multiple brace treatment options, alongside recommendations for various physiotherapeutic approaches, either in conjunction with brace treatment or as standalone interventions.

However, there is no universally accepted consensus regarding the conservative management of kyphosis that simultaneously ensures substantial patient satisfaction and heightened bodily awareness. Notably, there have been no studies investigating the efficacy of stretching in the treatment of individuals with kyphosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ages 8 and older with postural or Scheuermann's kyphosis with >45° of kyphosis or >10° of thoracolumbar kyphosis from T11-L1 or other cases which seem to have excessive kyphosis.
  • Parents of patients aged 17 and younger who are 18 and older and cognitively able to complete a survey will be included in the study as well.

Exclusion criteria

  • Patients with congenital kyphosis or scoliosis greater than 30°.
  • Parents of patients aged 17 and younger who are less than 18 years of age or cognitively unable to complete a survey will be excluded from the study.
  • Any records flagged "break the glass" or "research opt out."

Treatment and study plan

Exercises

Other

Stretching exercises with and without a bolster, ball, or foam roller.

Primary outcomes

  1. Kyphosis angle

    Time frame: Enrollment, 6-month follow-up, 2-year follow-up

    Change in severity of kyphosis angle evaluated using radiographs

Secondary outcomes

  1. Patient Satisfaction and Perception

    Time frame: Enrollment, 6-month follow-up, 2-year follow-up

    Patient Satisfaction and Perception measured via questionnaires

  2. Parental Perception

    Time frame: Enrollment, 6-month follow-up, 2-year follow-up

    Parental Perception of kyphosis measured via questionnaires

  3. Exercise Adherence

    Time frame: Enrollment, 6-month follow-up, 2-year follow-up

    Exercise Adherence measured via questionnaires

Study contacts

Contact information is provided by the study sponsor or research team.

Cristabelle Alexander, BS

CONTACT

[email protected]

310-423-1061

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Effectiveness of Various Exercises in Managing Kyphosis

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Oct 13, 2023
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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