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

NCT ID: NCT03046472

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2018-12-01

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.

Conditions

Postural Kyphosis, Thoracic Region

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Physical Therapy treatment for Postural Behavior

Intervention Type: OTHER

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.

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

Group Type: ACTIVE_COMPARATOR

Physical Therapy treatment for Postural Behavior

Intervention Type: OTHER

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.

Interventions

Physical Therapy treatment for Postural Behavior

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assuta Hospital Systems

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asaf Peretz, MD

Role: PRINCIPAL_INVESTIGATOR

Deputy Medical Director-Maccabi Health Services-Jerusalem hashfela

Neta Vitman, PT BA

Role: STUDY_DIRECTOR

Phisical Therapy Maccabi Health services-Modiin Clinic

Locations

Phisical Therapy Clinic Maccabi Health Services

Modiin, Jerusalem-Hashfela, Israel

Countries

Israel

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Assuta-0133-16-ASMC-AP-CTIL

Identifier Type: -

Identifier Source: org_study_id