Scoliosis-specific Exercises for Mild Idiopathic Scoliosis

NCT05138393 | Recruiting

• 1 other identifier: ED-PG-AA-2021-SSE
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. In Sweden, mild scoliosis curves not requiring treatment, but at risk for progression during childhood, are only observed until skeletal maturity without active treatment. If progression occurs and treatment is required, standard treatment consists of bracing 20 hours or more per day. Scoliosis-specific exercises have been reported to be a possible treatment modality in terms of halting progression in mild scoliosis, but the findings are not generally accepted.

Conditions

Idiopathic Scoliosis

Keywords

Idiopathic scoliosis; Randomized controlled trial; Exercise; Rehabilitation; Self-correction

Outcome Measures

Primary Outcomes (1)

• Number of patients progressing in curve severity

  Increase in curve severity (Cobb angle) of more than 6 degrees on two consecutive full-spine frontal radiographs as compared with baseline

  Measured at each radiological (annual) follow-up until skeletal maturity. Skeletal maturity is defined as less than 1 cm body height increase in 6 months

Secondary Outcomes (6)

• Angle of trunk rotation

  At each six-month follow-up and at 2, 5, 10 years after skeletal maturity

• Patient-reported outcome measures

  At each six-months follow-up and 2, 5, 10 years after skeletal maturity

• Patient-reported outcome measures

  At each six-month follow-up and 2, 5, 10 years after skeletal maturity

• Patient-reported outcome measures

  At each six-month follow-up, and 2, 5, 10 years after skeletal maturity

• Patient-reported outcome measures

  At each six-month follow-up, and 2, 5, 10 years after skeletal maturity

Study Arms (2)

Active self-corrective exercises

EXPERIMENTAL

An active self-correction tailored to the individual type of curve and clinical presentation will be applied with the aim to correct the scoliosis in all three planes. Patients will also be informed and educated in task oriented activities of daily living. Training goals are directed towards postural control, spinal stability, muscular stabilization and endurance in corrective postures. Patients will have outpatient sessions once every two weeks the first 3 months and perform the exercises at home in 30-minutes sessions three times per week. Patients are encouraged to continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily. Compliance will be monitored through a mobile application (Physitrack) where the patients record their sessions and can have contact with the research personnel. A cognitive behavioral therapy approach to reinforce physical activity will be performed every 6 months.

Other: Active self-corrective exercises

Observation

ACTIVE COMPARATOR

Patients are encouraged to continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. A cognitive behavioral therapy approach to reinforce physical activity will be performed every 6 months.

Other: Observation

Interventions

Active self-corrective exercises OTHER

Scoliosis specific exercises with an Active self-corrective approach. Non-specific physical activity 60 minutes per day.

Active self-corrective exercises

Observation OTHER

Non-specific physical activity 60 minutes per day.

Observation

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Cobb 15-24 degrees
• Skeletally immature, Sanders score of 4 or less and Risser \< 2.
• No menarche for females
• Aged 9-15 years
• Apex of the primary curve at T7 or caudal

You may not qualify if:

• Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
• No previous surgical or brace treatment for scoliosis

Sponsors & Collaborators

• Karolinska Institutet: lead
• Linkoeping University: collaborator

Study Sites (2)

Linköping university hospital

Linköping, Sweden

RECRUITING

Karolinska university hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Observation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Elias Diarbakerli, PT, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elias Diarbakerli, PT, PhD

CONTACT

+460851770000; elias.diarbakerli@regionstockholm.se

Paul Gerdhem, MD, PhD

CONTACT

paul.gerdhem@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 1, 2021
• Study Start: February 18, 2022
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2037
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol will be submitted to a peer-reviewed journal.
• Access Criteria: The investigators in charge will be responsible for reviewing access requests. Crude data, randomization procedures and intervention details can be shared with other researchers upon request.

Locations

SE (2)