An interventional study of Physical Therapy treatment for Postural Behavior in Postural Kyphosis, Thoracic Region, sponsored by Assuta Hospital Systems. Completed at 1 site in Israel. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Assuta Hospital Systems · Not applicable, Interventional, and Treatment
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.
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.
132 studies on the registry are indexed under Kyphosis; 31 are open to participants now.
This study's enrollment of 50 is above the median of 44 across 82 interventional studies indexed under Kyphosis.
Browse Kyphosis studies →Assuta Hospital Systems is the lead sponsor of 34 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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
Time frame: 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.
Time frame: 2 time points. before starting intervention and after 3 months.
| Milestone | Once a Month Only. | Once a Month and Once a Week. |
|---|---|---|
| Started | 33 | 17 |
| Completed | 33 | 17 |
| Not completed | 0 | 0 |
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.
| degrees | Once a Month Only. | Once a Month and Once a Week. |
|---|---|---|
| Curve angle baseline | 39.2 ± 9.3 | 38.9 ± 9.3 |
| Curve angle end | 27.9 ± 7.8 | 28.2 ± 6.8 |
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
| score on a scale | Once a Month Only. | Once a Month and Once a Week. |
|---|---|---|
| LBP Baseline | 5.5 ± 2.1 | 5.6 ± 2.2 |
| LBP End | 2.8 ± 2.0 | 1.6 ± 1.9 |
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.
| score on a scale | Once a Month Only. | Once a Month and Once a Week. |
|---|---|---|
| Difference Overall back postural behavior | 6.7 ± 3.1 | 9.0 ± 2.3 |
| Difference spontaneous back postural behavior end | 3.0 ± 1.9 | 4.1 ± 1.7 |
Collected over 3 months for each patient. total time of collecting data no more then 10 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Once a Month Only. | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Once a Month and Once a Week. | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | Once a Month and Once a Week. | Once a Month Only. | Total |
|---|---|---|---|
| <=18 years | 17 | 33 | 50 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Once a Month and Once a Week. | Once a Month Only. | Total |
|---|---|---|---|
| Mean | 14.2 ± 2.1 | 14.0 ± 1.9 | 14.2 ± 1.9 |
| Sex: Female, Male(Participants) | Once a Month and Once a Week. | Once a Month Only. | Total |
|---|---|---|---|
| Female | 10 | 16 | 26 |
| Male | 7 | 17 | 24 |
| Race and Ethnicity Not Collected(Participants) | Once a Month and Once a Week. | Once a Month Only. | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Once a Month and Once a Week. | Once a Month Only. | Total |
|---|---|---|---|
| Israel | 17 | 33 | 50 |
| Thorax curve angel(degrees) | Once a Month and Once a Week. | Once a Month Only. | Total |
|---|---|---|---|
| Mean | 39.2 ± 9.3 | 38.9 ± 9.3 | 39.0 ± 9.8 |
| Low back Pain in VAS Scale(units on scale 0-10) | Once a Month and Once a Week. | Once a Month Only. | Total |
|---|---|---|---|
| Mean | 5.6 ± 2.2 | 5.5 ± 2.1 | 5.5 ± 2.1 |
| Overall Back Postural Behavior(units on scale 0-16) | Once a Month and Once a Week. | Once a Month Only. | Total |
|---|---|---|---|
| Mean | 2.1 ± 1.8 | 2.2 ± 2.4 | 2.2 ± 2.2 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2017 to primary completion in Dec 2017, 9 months.
Results were first posted in Jan 2020, 2 years 1 month after primary completion.
Of 56 non-industry interventional studies with no phase under Kyphosis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's 9 months is close to that.
Counting every sponsor, half of 58 studies reached it within 9 months; a quarter within 4 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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