Protocol of Accelerated Rehabilitation Following Surgical Correction of Adolescent Idiopathic Scoliosis — PARIS  

Scoliosis Idiopathic Clinical Trial

Official title: A Protocol of Accelerated Rehabilitation for Patients Undergoing Adolescent Idiopathic Scoliosis Correction Surgery - An Internal Pilot Study

Status Completed

Clinical Trial 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, 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.

Clinical Trial Description

This is an internal pilot study, comprising a small pragmatic, RCT conducted at the Royal Orthopaedic Hospital NHS Foundation Trust. It will aim to test whether an accelerated rehabilitation protocol can be implemented safely and effectively for patients following correction surgery for AIS and, if so, whether the intervention leads to an improvement in activity levels or quality of life scores in the study group. It will also aim to identify whether it is feasible to implement such a programme as part of a bigger RCT in the future based on the attendance rate and functional improvements.

Recruitment:

Participants will be identified and recruited pre-operatively through the spinal deformity waiting list. The Eligibility of participants can be obtained through their medical notes.

Once identified and confirmed as eligible, participants will be approached by one of the research nurses and invited to take part in the study. There are two potential pathways to recruitment:

• If the participant is due to have a clinic appointment (such as a pre-operative assessment) within one month of their surgery, then patient information sheets and study invitation letters will be given to them at this appointment with their normal pre-operative information, by a research nurse. Follow up telephone calls can be conducted 7-10 days later to give participants and parents time to read and consider the information. Consent can be obtained at subsequent pre-operative appointments if any are scheduled (giving participants time to consider before consent), or at the time of admission for surgery should the participant want more time to consider.

• If the patient has already completed their pre-operative assessment and is not due to attend for any further appointments prior to their surgery, they will be sent this information in the post. Participants will be given adequate time to read and consider the information given. This time scale has been set at 7-10 days, to give participants and their parents plenty of time to read the information and consider it before contacting them. A telephone call will then take place prior to their admission to ask whether they have read and had time to consider the information and whether they have any questions. If they would like to take part in the trial, then a research clinician will meet with them the day before their surgery, when they are admitted, in order to fill in the consent form and to fill in the baseline questionnaire.

Evidence of screening for all potential participants, whether recruited or not, should be kept and recorded.

Post-Operatively:

Following their surgery, a research clinician will visit the participant on the ward, approximately 3-4 days after their surgery. This is to check from the operation records that there has not been any surgical complications that would exclude them from the study, and to check that the participant and their parents are still happy to take part in the study. If so, the participant will be randomised by the research clinician at this point. Randomisation will be performed using sealed envelopes. The results of the randomisation will be given to the treating physiotherapist. Prior to the participants discharge home from the ward, the treating physiotherapist will inform the participant which group they have been allocated to. If they are in the intervention arm their outpatient physiotherapy appointments will be booked for them at this point. If they are randomised to the usual care arm, then the patient will be discharged from the ward and will not be required to attend for any further physiotherapy. All patients will have the same level of inpatient care on the ward prior to discharge home.

Intervention:

There are two arms to the trial and there will be 10 participants randomly allocated to each arm. The control group will be seen by the physiotherapist on the ward and given daily physiotherapy up until the point of discharge home. They will then not have any further physiotherapy follow up, as part of usual care, unless there are any post-operative complications that require a physiotherapy referral. If a participant in the control group is referred back into secondary care for physiotherapy during the trial, then this will be recorded as a deviation from the protocol and included in final analysis.

The intervention group involves the same inpatient care as the control arm, plus 12 sessions of physiotherapy as an outpatient, and this will start 6 week post-operatively. The participants will initially come once a week for 6 weeks. Then from 12 weeks post-operatively they will be required to come once every 2 weeks. The treatment will be pragmatic depending on the patients individual goals and needs, but will follow the accelerated rehabilitation protocol that has been agreed with the spinal deformity consultant surgeons. Once the participants in the intervention arm have completed their 12 sessions, they will be discharged from physiotherapy for self-management, unless they have any on-going physiotherapy related needs. In this case they can continue with physiotherapy and it will be recorded as a deviation from the protocol.

Data Collection and Follow Up:

All 20 participants will fill in a baseline data collection booklet at the time of consent, which is just before their surgery. This includes patient reported outcome measures. All participants in both groups will be followed up at approximately 6 months, and again at 12 months, following their surgery. Where possible, participants will be approached at their 6 month and 12 months consultant review appointments to fill out the questionnaires for data collection. If this is not possible, then the questionnaires will be sent out in the post for them to complete and return to the research department. The questionnaires booklets contain:

Data will also be collected regarding recruitment rates, compliance with the intervention and serious adverse events (SAEs). ;

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic

• NCT number: NCT03719807
• Study type: Interventional
• Source: The Royal Orthopaedic Hospital NHS Trust
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Completion date: November 30, 2022