NCT03212664

Brief Summary

This proposal is a single center preliminary prospective cohort trial that evaluates patients with hyperkyphosis. Participants will receive physical therapy exercises and be followed for the above outcome measures over time. The treatment arm will receive training in one-time training in kyphosis-specific exercises. It is hypothesized that participants receive physical therapy exercises will demonstrate improved outcome measures over time. Also, it is hypothesized that participants who receive kyphosis-specific exercises will demonstrate significantly improved perceived quality-of-life and significantly reduced pain, compared to participants who receive generalized back exercises after 6 months. Also, it is hypothesized that a kyphosis-specific SAQ will demonstrate satisfactory test-retest reliability and concurrent validity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 5, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2020

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

2.6 years

First QC Date

July 3, 2017

Last Update Submit

September 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • survey

    19 items that identify factors related to exercise adherence, app usability and acceptability

    6 month follow-up

Secondary Outcomes (2)

  • pain intensity

    baseline

  • pain intensity

    6 month follow-up

Study Arms (1)

Exercise

OTHER

Schroth-based physical therapy exercises for patients who agree to participate in exercises. Will be compared to observation-only treatment

Other: exercise

Interventions

physical therapy exercises

Exercise

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosis of hyperkyphosis
  • ages 10 to 18 years
  • Cobb angles at least 50°
  • pain \>2 on the VAS during the past week.

You may not qualify if:

  • scoliosis greater than 25°
  • conditions preventing understanding and compliance with an exercise schedule
  • current brace wear
  • previous spine surgery
  • inability to commit to at least 15 minutes of exercises for 3 days a week
  • pain \<2 on the VAS during the past week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Scottish Rite Hospital for Children

Dallas, Texas, 75219, United States

Location

Related Publications (1)

  • Zapata KA, Wang-Price SS, Fletcher TS, Johnston CE. Factors influencing adherence to an app-based exercise program in adolescents with painful hyperkyphosis. Scoliosis Spinal Disord. 2018 Jul 18;13:11. doi: 10.1186/s13013-018-0159-x. eCollection 2018.

MeSH Terms

Conditions

Kyphosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karina A Zapata, PhD

    Texas Scottish Rite Hospital for Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research therapist

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 11, 2017

Study Start

August 5, 2014

Primary Completion

March 1, 2017

Study Completion

May 5, 2020

Last Updated

October 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations