Protocol of Accelerated Rehabilitation Following Surgical Correction of Adolescent Idiopathic Scoliosis
Protocol of Accelerated Rehabilitation Following Surgical Correction of Adolescent Idiopathic Scoliosis
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.
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).
Inclusion Criteria:

 -  Aged between 11-18 years old at the time of surgery.

 -  Diagnosis of AIS confirmed by spinal deformity team.

 -  On the waiting list to have a posterior or combined anterior/posterior scoliosis
 correction surgery.

 Exclusion Criteria:

 -  Underlying cause of scoliosis which makes it not idiopathic.

 -  Significant post-operative complications that prevents participation in the trial.

 -  Any significant learning disabilities or cognitive impairment that would limit the
 patient's ability to take part in the rehabilitation protocol.

 -  Planned anterior-only scoliosis correction surgery.

 -  Patients that are unable to understand verbal instructions or written information
 given in English.

 -  Patients involved in any other research trials.