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Clinical Trials/NCT03212664
NCT03212664CompletedNot Applicable

Effectiveness of Physical Therapy Exercises in Hyperkyphosis

Texas Scottish Rite Hospital for Children1 site in 1 country75 target enrollmentStarted: August 5, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
75
Locations
1
Primary Endpoint
survey

Study Overview

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.

Detailed Description

A total of 50 patients will be recruited for this study. 28 patients will be recruited for both groups, or 14 participants per group. Patients will be randomized by an independent research assistant who will draw the group number from a hat. We assume less than 15% attrition, which results in 12 participants per group.

Patients in both groups will ideally be followed after 6 months, unless the patient's treating orthopaedic surgeon schedules them for a visit up until 12 months later.

Group 1(Kyphosis-specific exercise Group): Patients will receive a one-time treatment consisting of kyphosis-specific exercises that promote depressing the thoracic convexity.

Group 2 (Generalized exercise group): Patients will receive a one-time treatment consisting of core strengthening, hamstring stretching, and generalized back extension exercises.

Patients in each group will be asked to perform these exercises at home about 10 minutes a day, 3 times a week.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
10 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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.

Arms & Interventions

Exercise

Other

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

Intervention: exercise (Other)

Outcomes

Primary Outcomes

survey

Time Frame: 6 month follow-up

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

Secondary Outcomes

  • pain intensity(6 month follow-up)
  • pain intensity(baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Karina Zapata, PT, DPT, PhD

research therapist

Texas Scottish Rite Hospital for Children

Study Sites (1)

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