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

Primary Purpose

Postural Kyphosis, Thoracic Region

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Physical Therapy treatment for Postural Behavior
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postural Kyphosis, Thoracic Region focused on measuring thorax curve angle

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Phisical Therapy Clinic Maccabi Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Once a month and once a week.

Once a month only.

Arm Description

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

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

Outcomes

Primary Outcome Measures

Thoracic Kyphosis Angle
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.
Low Back Pain
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
Back Postural Behavior
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.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2017
Last Updated
January 5, 2020
Sponsor
Assuta Hospital Systems
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1. Study Identification

Unique Protocol Identification Number
NCT03046472
Brief Title
Physical Therapy Treatment Once a Month Versus Once a Week for Posture Improvement in Children and Adolescents
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assuta Hospital Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Kyphosis, Thoracic Region
Keywords
thorax curve angle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will consist of two groups: a Treatment group and a control group. 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.
Masking
Investigator
Masking Description
One of the investigators has the role of examining the participants before and after the intervention. She will be blinded from the group allocation.
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Once a month and once a week.
Arm Type
Experimental
Arm Description
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
Arm Title
Once a month only.
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Physical Therapy treatment for Postural Behavior
Intervention Description
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.
Primary Outcome Measure Information:
Title
Thoracic Kyphosis Angle
Description
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.
Time Frame
2 time points. before starting intervention and after 3 months.
Title
Low Back Pain
Description
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
Time Frame
2 time points. before starting intervention and after 3 months.
Title
Back Postural Behavior
Description
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.
Time Frame
2 time points. before starting intervention and after 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children and Adolescent who referred by their pediatrician or orthopedic doctor to Physical Therapy treatment due to bad posture or Low Back Pain At the Physical Therapy clinic was found that this is truly the condition of bad posture or low back pain with bad posture. age 10-18 years they signed on informed consent. Exclusion Criteria: 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) Any sever health condition neurologic internal or orthopedic like Cerebral Palsy, Juvenile rheumatoid arthritis or Malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asaf Peretz, MD
Organizational Affiliation
Deputy Medical Director-Maccabi Health Services-Jerusalem hashfela
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neta Vitman, PT BA
Organizational Affiliation
Phisical Therapy Maccabi Health services-Modiin Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Phisical Therapy Clinic Maccabi Health Services
City
Modiin
State/Province
Jerusalem-Hashfela
ZIP/Postal Code
7177806
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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

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