Clinical trial NCT02807545: Scoliosis-Specific Exercises for At-Risk AIS Curves
Official title: Scoliosis-Specific Exercises for At-Risk Mild Adolescent Idiopathic Scoliosis Curves: A Multi-Site Preliminary Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis-Specific Exercises
Schroth
Lead sponsor: Texas Scottish Rite Hospital for Children
Sponsor class: OTHER
Collaborators: name: Scoliosis Research Society
name: Boston Children's Hospital
name: Columbia University
name: Norton Leatherman Spine Center
name: Johns Hopkins University
name: Baylor College of Medicine
First posted: 2016-06-21
Enrollment: 98
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. 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.
2. 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:

1. First session: 2 hours
2. Session 2: 1 hour (1 week later)
3. Session 3: 1 hour (1-2 weeks later)
4. Session 4: 1 hour (2-3 weeks after Session 3)
5. Session 5: 1 hour (3-4 weeks after Session 4)
6. Session 6: 1 hour (1-2 months after Session 5)
7. Session 7: 1 hour (1-2 months after Session 6)

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:

1. Correctly move the pelvis so the body weight is over the base of support and neutral.
2. Accurately set up exercises per curve pattern in different positions. Exercises progress from static to dynamic and passive to active corrections.
3. Proficiently perform a minimum of 8 exercises integrating scoliosis-specific corrections which include auto-elongation to increase the spaces between the pelvis, vertebrae, and ribs. Various kinesthetic, mental imagery and proprioceptive strategies are used to further open concavities and depress convexities.
4. Perform scoliosis-specific corrections during activities of daily living. The overall goal is for patients to maintain a corrective posture throughout the day.

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.

Eligibility criteria: Inclusion Criteria:

All patients diagnosed with Adolescent Idiopathic Scoliosis who meet the following inclusion criteria will be eligible to participate in this trial:

1. Age 10 to 17 years
2. Major curve Cobb angles of 12° to 24°
3. Risser Grade 0
4. Single thoracic, thoracolumbar, or lumbar curve patterns

Exclusion Criteria:

Patients will be excluded according to the following exclusion criteria:

1. Scoliosis other than AIS (congenital, neuromuscular, etc)
2. Upper thoracic or double curve patterns
3. Diagnosis of a developmental disorder that prevents understanding and compliance with an exercise schedule
4. Current or previous brace wear
5. Previous participation in a SSE program
6. Previous spine surgery
7. Patient inability to commit to attend at least 8 hours of PT within 6 months

Primary outcomes:
measure: Overall Recruitment Rate
timeFrame: through study completion up to 45 months
measure: Treatment Attendance in the SSE Group
timeFrame: after 1 year
measure: Home Exercise Adherence in the SSE Group According to Weekly E-mails
timeFrame: 1 year
Secondary outcomes:
measure: Curve Magnitude
timeFrame: 1 year
measure: Curve Progression
timeFrame: after 1 year
measure: Brace Prescription
timeFrame: after 1 year
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Leatherman Spine Center
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Dallas
country: United States
facility: Texas Scottish Rite Hospital for Children
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Scottish Rite for Children
name: Karina Zapata, PhD
role: PRINCIPAL_INVESTIGATOR
References: