Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multicentre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2).

INTRODUCTION: Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation. METHODS AND ANALYSIS: The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022. TRIAL REGISTRATION NUMBER: ISRCTN11499185.

Hearing Aids Do Not Alter Cortical Entrainment to Speech at Audible Levels in Mild-to-Moderately Hearing-Impaired Subjects.

BACKGROUND: Cortical entrainment to speech correlates with speech intelligibility and attention to a speech stream in noisy environments. However, there is a lack of data on whether cortical entrainment can help in evaluating hearing aid fittings for subjects with mild to moderate hearing loss. One particular problem that may arise is that hearing aids may alter the speech stimulus during (pre-)processing steps, which might alter cortical entrainment to the speech. Here, the effect of hearing aid processing on cortical entrainment to running speech in hearing impaired subjects was investigated. METHODOLOGY: Seventeen native English-speaking subjects with mild-to-moderate hearing loss participated in the study. Hearing function and hearing aid fitting were evaluated using standard clinical procedures. Participants then listened to a 25-min audiobook under aided and unaided conditions at 70 dBA sound pressure level (SPL) in quiet conditions. EEG data were collected using a 32-channel system. Cortical entrainment to speech was evaluated using decoders reconstructing the speech envelope from the EEG data. Null decoders, obtained from EEG and the time-reversed speech envelope, were used to assess the chance level reconstructions. Entrainment in the delta- (1-4 Hz) and theta- (4-8 Hz) band, as well as wideband (1-20 Hz) EEG data was investigated. RESULTS: Significant cortical responses could be detected for all but one subject in all three frequency bands under both aided and unaided conditions. However, no significant differences could be found between the two conditions in the number of responses detected, nor in the strength of cortical entrainment. The results show that the relatively small change in speech input provided by the hearing aid was not sufficient to elicit a detectable change in cortical entrainment. CONCLUSION: For subjects with mild to moderate hearing loss, cortical entrainment to speech in quiet at an audible level is not affected by hearing aids. These results clear the pathway for exploring the potential to use cortical entrainment to running speech for evaluating hearing aid fitting at lower speech intensities (which could be inaudible when unaided), or using speech in noise conditions.