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Trial record 1 of 7 for:    hyperkyphosis
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Physical Therapy Exercises in Hyperkyphosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03212664
Recruitment Status : Terminated (participants did not adhere to study protocol)
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
Karina Zapata, PT, DPT, PhD, Texas Scottish Rite Hospital for Children

Brief Summary:
The primary aim was to assess whether a one-time physical therapy program for hyperkyphosis is effective. Participants received physical therapy exercises and were followed for 6 months for pain intensity, quality-of-life, and perceived spinal appearance.

Condition or disease Intervention/treatment Phase
Hyperkyphosis Other: exercise Not Applicable

Detailed Description:

All participants were instructed in a one-time physical therapy exercise treatment. The exercise treatment consisted of five exercises. Participants were instructed to perform each exercise for 100 seconds. Participants were instructed to performing these 5 exercises for at least 3 days a week for 6 months.

In addition, each participant was given access to a software application (app) called "Pt pal" on their smart phone or tablet. Participants were asked to use the app whenever they performed their exercises throughout the 6- month period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Physical Therapy Exercises in Hyperkyphosis
Actual Study Start Date : August 5, 2014
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : June 21, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Exercise Other: exercise
physical therapy exercises

Primary Outcome Measures :
  1. survey [ Time Frame: 6 month follow-up ]
    19 items that identify factors related to exercise adherence, app usability and acceptability

Secondary Outcome Measures :
  1. pain intensity [ Time Frame: baseline ]
    Numeric Pain Rating Scale

  2. pain intensity [ Time Frame: 6 month follow-up ]
    Numeric Pain Rating Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Karina Zapata, PT, DPT, PhD, research therapist, Texas Scottish Rite Hospital for Children Identifier: NCT03212664    
Other Study ID Numbers: 1143
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No