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| Name | Class |
|---|---|
| Scoliosis Research Society | OTHER |
| Boston Children's Hospital | OTHER |
| Columbia University | OTHER |
| Norton Leatherman Spine Center |
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This study will be a multi-center, dual-arm randomized control study evaluating skeletally immature patients with mild AIS curves. At six institutions, patients will be randomized into either the scoliosis-specific exercise (SSE) treatment arm or a control group. The SSE group will receive training in SSE, posture, and activities of daily living by physical therapists certified in Schroth-based exercise methods. The control group will not receive SSE instruction and will only be observed by their treating orthopaedic surgeon (which is considered the standard-of-care treatment method). Results will be compared after one year of treatment.
All patients with AIS meeting the following inclusion criteria will be eligible to participate in this trial: diagnosis of AIS; ages 10 to 17 years; major curve Cobb angles 15° to 20°; thoracolumbar, lumbar, or primary thoracic curve patterns; and Risser grade 0. Curves less than 15° will not be as clinically meaningful if they do not progress more than 5°. Curves 15° also allow for 5° of measurement error. Curves more than 20° will not be able to progress at least 5° before bracing is initiated according to SRS criteria (at 25°). Patients will be excluded according to the following exclusion criteria: scoliosis other than AIS, upper thoracic or double curve patterns, developmental disorders that prevent understanding and compliance with an exercise schedule, current or previous brace wear, and previous participation in a SSE program, previous spine surgery, inability to commit to performing a home exercise program for 15 minutes a day, 5 days a week, and inability to commit to attend at least 8 hours of PT within 6 months.
Patient medical records will be reviewed for eligibility. If a patient is deemed eligible for inclusion in the study, a member of the research team will meet with the patient and his or her family to review the consent form in a private medical exam room. The family will be given ample time to review the consent form and ask any questions. If a participant chooses to participate, a consent form will be signed by both the patient and the legal guardian prior to any investigational procedures occurring. Once a consent form has been signed, patients will be randomly assigned by the TSRH on site statistician to one of the two following groups:
Standardization of Physical Therapy:
Physical therapists from Texas Scottish Rite Hospital, Boston Children's Hospital, Columbia University Medical Center, Norton Leatherman Spine Center, Johns Hopkins University, and Texas Children's Hospital who received training and certification in the Schroth-based (BSPTS) method have been recruited as members of the study team. Physical therapists at each institution will deliver a standardized exercise intervention.
Study Groups:
A) Scoliosis-Specific Exercise (SSE) Group
Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions:
The exact number of training sessions and time frame will be determined by the patient's ability to perform the exercises. All therapists will use a standardized exercise prescription algorithm and performance checklist similar to Dr. Parent's Schroth scoliosis exercise study. Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises according to the following criteria:
Patients will be asked to use a smartphone or tablet application (app) when performing the home exercise program which will be one method of tracking exercise adherence. A paper version of the app will be available to patients without access to a smartphone or tablet.
Patients will also be sent electronically a weekly survey regarding home exercise adherence through a secure research database, the Research Electronic Data Capture (REDCap). An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer.
Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.
B) Control Group Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months. Once all measurements have been collected at the patient's enrollment and one year followup, patients in this group will continue to be tracked through observation until skeletal maturity in order to record whether the patient experienced curve progression, was prescribed a brace, or proceeded to surgical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Therapy Exercise Group | Experimental | Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions. Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer. Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months. |
|
| Control Group | No Intervention | Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scoliosis Specific Exercises | Behavioral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Recruitment Rate | Measured by the number of participants enrolled through study completion. | through study completion up to 45 months |
| Treatment Attendance in the SSE Group | Measured by the number of prescribed hours of physical therapy sessions attended after 1 year | after 1 year |
| Home Exercise Adherence in the SSE Group According to Weekly E-mails | Measured by the percentage of prescribed exercises completed from baseline to 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Curve Magnitude | Measured by the Cobb angle on radiograph | 1 year |
| Curve Progression | Percentage of participants whose curve progressed >5 degrees |
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Inclusion Criteria:
All patients diagnosed with Adolescent Idiopathic Scoliosis who meet the following inclusion criteria will be eligible to participate in this trial:
Exclusion Criteria:
Patients will be excluded according to the following exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karina Zapata, PhD | Scottish Rite for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Leatherman Spine Center | Louisville | Kentucky | 40202 | United States | ||
| Johns Hopkins |
We never intended to make IPD available to other researchers. Our plan was only to share de-identified data with one lead institution.
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| ID | Title | Description |
|---|---|---|
| FG000 | Physical Therapy Exercise Group | Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions. Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer. Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months. Scoliosis Specific Exercises |
| FG001 | Control Group | Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Physical Therapy Exercise Group | Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions. Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer. Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months. Scoliosis Specific Exercises |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Recruitment Rate | Measured by the number of participants enrolled through study completion. | Posted | Count of Participants | Participants | through study completion up to 45 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Physical Therapy Exercise Group | Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions. Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer. Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months. Scoliosis Specific Exercises |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karina Zapata | Scottish Rite for Children | 214-559-7790 | karina.zapata@tsrh.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2019 | Apr 12, 2023 | Prot_SAP_000.pdf |
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| OTHER |
| Johns Hopkins University | OTHER |
| Baylor College of Medicine | OTHER |
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| after 1 year |
| Brace Prescription | Measured by the percentage of participants prescribed a brace | after 1 year |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Texas Scottish Rite Hospital for Children | Dallas | Texas | 75219 | United States |
| Texas Children's Hospital | Houston | Texas | 75235 | United States |
| BG001 | Control Group | Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| AIS Risser 0 curves 12-24 degrees | Mean | Standard Deviation | degrees |
|
| OG001 | Control Group | Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months. |
|
|
| Primary | Treatment Attendance in the SSE Group | Measured by the number of prescribed hours of physical therapy sessions attended after 1 year | Posted | Mean | Standard Deviation | hours | after 1 year |
|
|
|
| Primary | Home Exercise Adherence in the SSE Group According to Weekly E-mails | Measured by the percentage of prescribed exercises completed from baseline to 1 year | Posted | Mean | Standard Deviation | percentage of exercises completed | 1 year |
|
|
|
| Secondary | Curve Magnitude | Measured by the Cobb angle on radiograph | Posted | Mean | Standard Deviation | degrees | 1 year |
|
|
|
| Secondary | Curve Progression | Percentage of participants whose curve progressed >5 degrees | Out of the 35 participants in the Exercise group who completed the study and 22 participants in the Control group who completed the study, 34 participants in the Exercise group and 21 participants in the Control group had curve magnitude data to report curve progression, since 1 patient in each group did not receive radiographic measurements at that timepoint. | Posted | Count of Participants | Participants | after 1 year |
|
|
|
| Secondary | Brace Prescription | Measured by the percentage of participants prescribed a brace | Posted | Count of Participants | Participants | after 1 year |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control Group | Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months. | 0 | 22 | 0 | 22 | 0 | 22 |
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