Physical Therapy Exercises in Hyperkyphosis
Effectiveness of Physical Therapy Exercises in Hyperkyphosis
1 other identifier
interventional
75
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 3, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2020
CompletedOctober 8, 2021
September 1, 2021
2.6 years
July 3, 2017
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
OTHERSchroth-based physical therapy exercises for patients who agree to participate in exercises. Will be compared to observation-only treatment
Interventions
Eligibility Criteria
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
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.
PMID: 30027121DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karina A Zapata, PhD
Texas Scottish Rite Hospital for Children
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