The PARIS Study 1.0
Research type
Research Study
Full title
A Protocol of Accelerated Rehabilitation for adolescents undergoing Idiopathic Scoliosis correction surgery - An Internal Pilot Study.
IRAS ID
243004
Contact name
Jodie Walters
Contact email
Sponsor organisation
The Royal Orthopaedic Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study aims to identify whether an accelerated physiotherapy led rehabilitation programme for adolescents undergoing idiopathic scoliosis correction surgery can be delivered safely and effectively post-operatively.
This research is being conducted as previous research indicates that up to 41% of patients who have surgical correction of their scoliosis either return to athletic activity at a lower level than before, or they do not return to athletic activity at all. This is despite significant advancement in the instrumentation being used in recent years which makes the corrections more stable and robust. Some studies have shown that surgically treated AIS patients have significantly reduced physical function and quality of life scores, and that this could be improved with exercise. So far no trials have investigated whether post-operative rehabilitation can improve quality of life for these patients.
The initial study will be a pilot study, comprising of 20 participants in a small, pragmatic randomised controlled trial. It will be conducted at The Royal Orthopaedic Hospital, a specialist orthopaedic centre. Adolescents (between 11-18 years of age) who have a diagnosis of AIS and are on the waiting list for surgical correction of this scoliosis will be included. The study will compare a post-operative accelerated rehabilitation programme with usual care and investigate if the accelerated intervention can be delivered safely and effectively after this procedure. Following surgery, both groups will have the same inpatient rehabilitation up until the point of discharge home. The intervention group will then complete 12 sessions of physiotherapy as an outpatient, which starts at 6 week post-op. The usual care group will not have any further physiotherapy, in line with current standard practice at this centre. Both groups will be assessed using patient reported outcome measures pre-operatively, and at 6 months and 12 months post-operatively, measuring function and quality of life.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
18/WM/0387
Date of REC Opinion
5 Feb 2019
REC opinion
Further Information Favourable Opinion