None listed
Conditions
Brief summary
Many people who have shoulder stabilisation surgery do not return to their previous level of sport or activity, and current rehabilitation programs may be overly conservative. This pilot randomised controlled trial compares two physiotherapy rehabilitation programs in adults aged 16–40 following arthroscopic Bankart repair surgery: a standard time-based program (the American Society of Shoulder and Elbow Therapists, or ASSET, guideline) and a new criterion-based program called RISE (Rehabilitation for Instability with Structured Elements), which progresses based on individual recovery milestones rather than fixed timeframes. Participants will be randomly assigned to one of the two programs and followed up for six months, with shoulder function, strength, range of motion, pain, and psychological readiness assessed by an independent assessor. We hypothesise that the RISE program will result in greater shoulder function at six months without compromising safety. The findings will assess the feasibility of a larger trial and inform the design of a future definitive randomised controlled trial comparing the two approaches.
Interventions
The RISE (Rehabilitation for Instability with Structured Elements) protocol is a novel criterion-based rehabilitation program developed specifically for this trial. Rather than progressing at fixed time points, participants advance through four sequential stages (Early, Mid, Late, Return to Activity) by meeting specific clinical benchmarks across four concurrent elements: pain, range of motion, strength, and functional/psychological readiness. Meeting stage criteria advances exercise selection a
The RISE (Rehabilitation for Instability with Structured Elements) protocol is a novel criterion-based rehabilitation program developed specifically for this trial. Rather than progressing at fixed time points, participants advance through four sequential stages (Early, Mid, Late, Return to Activity) by meeting specific clinical benchmarks across four concurrent elements: pain, range of motion, strength, and functional/psychological readiness. Meeting stage criteria advances exercise selection and load; the total number of sessions remains fixed at 10 regardless of progression rate. Training is provided by the lead researcher: a 2-hour face-to-face session prior to trial commencement covering protocol rationale, stage progression criteria, and exercise selection, followed by monthly 1-hour face-to-face feedback and reflection sessions with treating physiotherapists throughout the trial period, which also serve as the ongoing supervision mechanism. Delivered face-to-face and individually by registered physiotherapists with experience in post-surgical orthopaedic rehabilitation, independent of the research team and not involved in outcome assessment. Delivered at participating physiotherapy clinics (Sydney Orthopaedic Physiotherapy, St Leonards NSW; Penrith Physiotherapy Sports Centre, Penrith NSW). 10 sessions over 6 months post-operatively, each approximately 30–45 minutes (up to 60 minutes at stage-transition assessment sessions). Session frequency varies according to individual progression through protocol stages. Additional sessions are permitted if clinically indicated and are recorded. Exercise intensity progresses from low to high across the four stages, monitored using the Borg RPE scale, with a pain ceiling of =3/10 during and after loading. Example exercises include isometric rotator cuff and scapular setting exercises (Early stage); resisted band external/internal rotation and weight-bearing progressions (Mid stage); progressive loaded rotation, rows, and presses (Late stage); and sport-specific and plyometric loading (Return to Activity stage). Adherence is monitored via physiotherapist-completed session attendance logs and treatment records. Protocol deviations are recorded.
Sponsors
RMIT University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Aged 16–40 years Scheduled for isolated arthroscopic Bankart repair for anterior shoulder instability Diagnosis confirmed by orthopaedic surgeon based on clinical assessment and imaging Sufficient English proficiency to provide informed consent and complete outcome measures Able to attend scheduled physiotherapy and assessment sessions at a participating site
Exclusion criteria
Beighton score greater than or equal to 5/9 (generalised hypermobility) Glenoid bone loss greater than or equal to 15% on pre-operative imaging Concurrent procedures performed at the time of Bankart repair that would require modification of the rehabilitation protocol (e.g. rotator cuff repair, SLAP repair, biceps tenodesis) Prior ipsilateral shoulder stabilisation surgery Significant health comorbidity precluding standard rehabilitation Inability to comply with trial requirements (e.g. planned relocation, unavailability for follow-up)
Outcome results
None listed