NCT03046472

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

February 5, 2017

Results QC Date

August 12, 2019

Last Update Submit

January 5, 2020

Conditions

Keywords

thorax curve angle

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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

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

  • 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.

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

Study Arms (2)

Once a month and once a week.

EXPERIMENTAL

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

Other: Physical Therapy treatment for Postural Behavior

Once a month only.

ACTIVE COMPARATOR

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

Other: Physical Therapy treatment for Postural Behavior

Interventions

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 and once a week.Once a month only.

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phisical Therapy Clinic Maccabi Health Services

Modiin, Jerusalem-Hashfela, 7177806, Israel

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Results Point of Contact

Title
Neta Vitman
Organization
Maccabi Health services and Wingate college

Study Officials

  • Asaf Peretz, MD

    Deputy Medical Director-Maccabi Health Services-Jerusalem hashfela

    PRINCIPAL INVESTIGATOR
  • Neta Vitman, PT BA

    Phisical Therapy Maccabi Health services-Modiin Clinic

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
One of the investigators has the role of examining the participants before and after the intervention. She will be blinded from the group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2017

First Posted

February 8, 2017

Study Start

February 15, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

January 18, 2020

Results First Posted

January 18, 2020

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations