ACtive Treatment for Idiopathic AdolescenT Scoliosis: a feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90480705

Enrollment

Registered

2011-10-25

Start date

2012-09-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent idiopathic scoliosis (AIS) Musculoskeletal Diseases Juvenile idiopathic scoliosis

Interventions

During the pilot RCT participants will be randomised to receive: 1. An excercise programme 2. Usual care Those randomised to the exercise programme will carry out the exercise programme primarily as

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants will be 10-16 years of age with Adolescent Idiopathic Scoliosis, defined by a Cobb angle of between 10 - 50 degrees (measured radiographically)

Exclusion criteria

Exclusion criteria: 1. Individuals who have had previous surgery or are on a waiting list for spinal surgery within the next 6 months 2. Individuals with non-idiopathic scoliosis, for example congenital malformations, syringomyelia, neurofibromatosis, spina bifida, polio and cerebral palsy

Design outcomes

Primary

Measure	Time frame
1. Assess the feasibility to progress to a full randomised controlled trial (RCT) 2. Calculation of the sample size for the RCT and an understanding of recruitment rates across centres 3. We anticipate that the primary outcome measures for a main RCT study will be the progression/stabilisation of curvature quantified by the Cobb angle and this will be measured in the pilot RCT	—

Secondary

Measure	Time frame
1. Progression to surgery 2. Changes to brace-wearing status 3. Respiratory function 4. Quality of life 5. Resource use associated with the provision and consequence of the different treatment options The questionnaires to be piloted include: 1. Scoliosis Research Society-22 questionnaire 2. Paediatric Outcomes Data Collection Instrument EQ-5D-Y 3. Health Utilities Index and SF-6D The commissioning brief requests measures of exercise tolerance and respiratory function and we will investigate the most appropriate method of capturing these outcomes (an incremental walk test is likely to be the best candidate).	—

Measure

Time frame

1. Progression to surgery 2. Changes to brace-wearing status 3. Respiratory function 4. Quality of life 5. Resource use associated with the provision and consequence of the different treatment options The questionnaires to be piloted include: 1. Scoliosis Research Society-22 questionnaire 2. Paediatric Outcomes Data Collection Instrument EQ-5D-Y 3. Health Utilities Index and SF-6D The commissioning brief requests measures of exercise tolerance and respiratory function and we will investigate the most appropriate method of capturing these outcomes (an incremental walk test is likely to be the best candidate).

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026