Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 1 of 7 for:    hyperkyphosis
Previous Study | Return to List | Next Study

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.
 
ClinicalTrials.gov Identifier: NCT03212664
Recruitment Status : Terminated (participants did not adhere to study protocol)
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
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.

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Karina Zapata, PT, DPT, PhD, research therapist, Texas Scottish Rite Hospital for Children
ClinicalTrials.gov 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No