NCT03719807: PARIS

Protocol of Accelerated Rehabilitation Following Surgical Correction of Adolescent Idiopathic Scoliosis

Completed NA Last updated 13 September 2023

What this trial tests

NA trial testing Rehabilitation protocol in Scoliosis Idiopathic in 23 participants. Completed in 30 November 2022.

Timeline

1 December 2018

Primary endpoint
30 November 2022

30 November 2022

Quick facts

Lead sponsor	The Royal Orthopaedic Hospital NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	23
Start date	1 December 2018
Primary completion	30 November 2022
Estimated completion	30 November 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Rehabilitation protocol
• Usual Care

Conditions studied

• Scoliosis Idiopathic — all drugs for Scoliosis Idiopathic →

Sponsor

The Royal Orthopaedic Hospital NHS Trust

Who can join

Adults 11 to 18, any sex, with Scoliosis Idiopathic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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, and whether it might improve activity levels and quality of life outcomes for the study group.

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 (RCT). It will be conducted at The Royal Orthopaedic Hospital, a specialist National Health Service (NHS) orthopaedic centre. Adolescents (between 11-18 years of age) who have a diagnosis of adolescent idiopathic scoliosis (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 (commenced at 6 weeks post surgery) 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, to assess function and quality of life.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Protocol of Accelerated Rehabilitation following surgery for adolescent Idiopathic Scoliosis (PARIS) : a feasibility study.
   Walters J, Stephens G, Gardner A. · · 2025 · PMID 40935367 · DOI 10.1302/2633-1462.69.bjo-2025-0012.r1