Trial Outcomes & Findings for Physical Therapy Treatment Once a Month Versus Once a Week for Posture Improvement in Children and Adolescents (NCT NCT03046472)

Last Updated: 2020-01-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

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

Results posted on

2020-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	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: 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. 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: 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.
Overall Study STARTED	33	17
Overall Study COMPLETED	33	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Once a Month and Once a Week. n=17 Participants 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: 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. n=33 Participants 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: 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.	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	17 Participants n=17 Participants	33 Participants n=33 Participants	50 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=17 Participants	0 Participants n=33 Participants	0 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=17 Participants	0 Participants n=33 Participants	0 Participants n=50 Participants
Age, Continuous	14.2 years STANDARD_DEVIATION 2.1 • n=17 Participants	14.0 years STANDARD_DEVIATION 1.9 • n=33 Participants	14.2 years STANDARD_DEVIATION 1.9 • n=50 Participants
Sex: Female, Male Female	10 Participants n=17 Participants	16 Participants n=33 Participants	26 Participants n=50 Participants
Sex: Female, Male Male	7 Participants n=17 Participants	17 Participants n=33 Participants	24 Participants n=50 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Israel	17 participants n=17 Participants	33 participants n=33 Participants	50 participants n=50 Participants
Thorax curve angel	39.2 degrees STANDARD_DEVIATION 9.3 • n=17 Participants	38.9 degrees STANDARD_DEVIATION 9.3 • n=33 Participants	39.0 degrees STANDARD_DEVIATION 9.8 • n=50 Participants
Low back Pain in VAS Scale	5.6 units on scale 0-10 STANDARD_DEVIATION 2.2 • n=12 Participants • not all participants had Low Back Pain	5.5 units on scale 0-10 STANDARD_DEVIATION 2.1 • n=21 Participants • not all participants had Low Back Pain	5.5 units on scale 0-10 STANDARD_DEVIATION 2.1 • n=33 Participants • not all participants had Low Back Pain
Overall Back Postural Behavior	2.1 units on scale 0-16 STANDARD_DEVIATION 1.8 • n=17 Participants	2.2 units on scale 0-16 STANDARD_DEVIATION 2.4 • n=33 Participants	2.2 units on scale 0-16 STANDARD_DEVIATION 2.2 • n=50 Participants
spontaneous Back Postural Behavior	0.5 units on scale 0-8 STANDARD_DEVIATION 0.8 • n=17 Participants	0.5 units on scale 0-8 STANDARD_DEVIATION 0.9 • n=33 Participants	0.5 units on scale 0-8 STANDARD_DEVIATION 0.9 • n=50 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Once a Month Only. n=33 Participants 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: 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. n=17 Participants 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: 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.
Thoracic Kyphosis Angle Curve angle baseline	39.2 degrees Standard Deviation 9.3	38.9 degrees Standard Deviation 9.3
Thoracic Kyphosis Angle Curve angle end	27.9 degrees Standard Deviation 7.8	28.2 degrees Standard Deviation 6.8

PRIMARY outcome

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

Population: only 33 out of 50 had LBP 21 in once a month group and 12 in once a month and once a week

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

Outcome measures

Outcome measures
Measure	Once a Month Only. n=21 Participants 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: 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. n=12 Participants 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: 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.
Low Back Pain LBP End	2.8 score on a scale Standard Deviation 2.0	1.6 score on a scale Standard Deviation 1.9
Low Back Pain LBP Baseline	5.5 score on a scale Standard Deviation 2.1	5.6 score on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Once a Month Only. n=33 Participants 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: 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. n=17 Participants 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: 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.
Back Postural Behavior Difference Overall back postural behavior	6.7 score on a scale Standard Deviation 3.1	9.0 score on a scale Standard Deviation 2.3
Back Postural Behavior Difference spontaneous back postural behavior end	3.0 score on a scale Standard Deviation 1.9	4.1 score on a scale Standard Deviation 1.7

Adverse Events

Once a Month Only.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Once a Month and Once a Week.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Neta Vitman

Maccabi Health services and Wingate college

Phone: 0508955529

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place