Physical Therapy Treatment Once a Month Versus Once a Week for Posture Improvement in Children and Adolescents

January 5, 2020 updated by: Assuta Hospital Systems

Physical Therapy Treatment Once a Month Versus Physical Treatment Once a Week for Posture Improvement in Children and Adolescents Who Suffer From Posture Problem or Low Back Pain

This study is design in a clinical setting for testing whether physical therapy treatment that includes postural awareness exercises for strength flexibility and endurance is improving low back pain and postural behavior. The study will consist of two groups, basic treatment that will get one on one treatment once a month for 3 months and the intervention group, will get an additional group therapy once a week.

Study Overview

Detailed Description

Background: Life time prevalence of Low Back Pain among Children and Adolescent ranges from 32% to 66%. This prevalence gets higher with age and among 17 years old it's equal to prevalence among adults. Previous episode of Low Back pain is a predicting risk factor to the next one, hence we should do preventative care at a young age, even before the first attack occur. Poor posture was found as one of the risk factors for Low Back Pain in children. Adolescence with neutral posture had less prevalence of Low Back Pain then those with poor posture. Prolong slouch sitting was associated with Low Back Pain. Prevention education programs, focusing on knowledge, did not show effective change in posture behavior. Hence, the researchers concluded that it's better if they focus on exercise.

Research Goal: comparison between physical therapy treatment for good posture once a week versus once a month, on postural behavior, thorax curve angle and Low Back Pain.

Research type: randomize, Interventional, blinded. Methods and Procedures Population: the study will include 50 children and adolescents age 10-18 years suffering from poor back posture, with or without Low Back Pain.

Procedure: The study will consist of two groups: both groups will get personal meeting once a month and a program of exercising at home every day. Treatment group will have in addition group meeting once a week and control group not. The intervention program will include physical awareness and practice for good posture, and exercises for flexibility, strength and muscle endurance.

Measurement tools:Digital Inclinometer for measuring thorax curve angle. Postural observation for measuring postural habits. Back pain and postural habits questionnaire for measuring LBP on VAS SCALE, postural knowledge and habits of participant, including demographic data. Parents' questionnaire for measuring parents' knowledge and ideas.

Research hypothesis: postural behavior, thorax curve angle and Low Back Pain will get better in both groups but more in the treatment group.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jerusalem-Hashfela
      • Modiin, Jerusalem-Hashfela, Israel, 7177806
        • Phisical Therapy Clinic Maccabi Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Children and Adolescent who referred by their pediatrician or orthopedic doctor to Physical Therapy treatment due to bad posture or Low Back Pain
  2. At the Physical Therapy clinic was found that this is truly the condition of bad posture or low back pain with bad posture.
  3. age 10-18 years
  4. they signed on informed consent.

Exclusion Criteria:

  1. Children and Adolescent who suffer from risk of structural deterioration as structural scoliosis(Cob angle above 20° and Risser sign equal or below 3) or structural Kyphosis (above 40° Risser sign equal or below 3 or Scheuermann Disease)
  2. Any sever health condition neurologic internal or orthopedic like Cerebral Palsy, Juvenile rheumatoid arthritis or Malignancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Once a month and once a week.

Personally meeting once a month of Physical Therapy treatment for Postural Behavior.

In addition exercise group meeting once a week. The intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.

All participants will get 10-15 minutes of exercise for performing every day. The Participants in this group will get also a group exercise meeting once a week That meeting will long 45 minutes and will include the exercise that were given as home work and more.

Total duration 12 weeks/3 months

Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.

All participants will get 10-15 minutes of exercise for performing every day.

Active Comparator: Once a month only.

Personally meeting once a month only for Physical Therapy treatment for Postural Behavior.

The intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.

All participants will get 10-15 minutes of exercise for performing every day. Total duration 12 weeks/3 months

Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.

All participants will get 10-15 minutes of exercise for performing every day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thoracic Kyphosis Angle
Time Frame: 2 time points. before starting intervention and after 3 months.

Normal thoracic kyphosis angle ranges between 25°-40°. Measuring by Digital Inclinometer by placing it on the spinous process of T1 and T12 and the outcome off subtraction the two numbers is our out come.

The participant is to stand how ever he think is the best posture.

2 time points. before starting intervention and after 3 months.
Low Back Pain
Time Frame: 2 time points. before starting intervention and after 3 months.
VAS Scale 0-10 0 no pain 1-2 very mild pain 2-3 mild pain 4-6 moderate pain 7-8 high pain 9-10 very high pain
2 time points. before starting intervention and after 3 months.
Back Postural Behavior
Time Frame: 2 time points. before starting intervention and after 3 months.

the investigator observes the participant in 8 different positions: sitting in the waiting room, walking to the treatment room, sitting in front of the therapist, placing a mattress on the floor, exercising in six position, exercising in sitting position, exercising in standing position, and changing between positions. Each position get a subscore as 0-bad posture 1-fair 2-good. Overall postural behavior: was comprised of all 8 observations including: grades 0 to 16. An higher score is a better behavior.

spontaneous behavior was comprised of 4 sob score that ha a spontaneous characteristics: sitting waiting for treatment, walking into the room, sitting during treatment and transition between exercises. summation of these 4 would range 0-8 . an Higher score is a better behavior.

2 time points. before starting intervention and after 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Asaf Peretz, MD, Deputy Medical Director-Maccabi Health Services-Jerusalem hashfela
  • Study Director: Neta Vitman, PT BA, Phisical Therapy Maccabi Health services-Modiin Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

February 5, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 5, 2020

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Assuta-0133-16-ASMC-AP-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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