Is an in-home telerehabilitation program for people with proximal humerus fracture as effective as a conventional face-to face rehabilitation program? A study protocol for a noninferiority randomized clinical trial

The aging population has placed in interesting pressure on our health system. In addition to different age-related conditions, the prevention and treatment of fragility fractures has become an important issue. Although osteoporosis treatments have improved in recent years, in addition to falls, the associated fractures are highly related to morbidity and mortality. Each year, one person out of three falls, and from them, 10 % causes a fracture [1]. The proximal humerus is one of the three most common fractured sites, along with the hip and wrist, making up 4 to 5 % of fractures, all sites combined [2].

Humerus fractures can be treated surgically (e.g. pinning, plate and screws, etc), or conservatively, typically through immobilisation in a splint or an orthotic device [3]. Conservative medical treatment tends to be advocated, mostly because of the complications that may occur following surgical intervention. However, the type of fracture, the surgeon, the patient and the fracture classification will influence the treatment decision. Among the existing proximal humerus fracture classifications (i.e. Neer [4], AO [5], Codman-Hertel [6], and Resch [7]), the Neer classification is the most widely used among orthopaedists. Neer group I and II fractures are often treated with the conservative approach, while group III and IV fractures most likely are surgical cases [8, 9]. Following both of these medical approaches, the individual needs rehabilitation to prevent functional limitations. Indeed, intervention programs in rehabilitation for humerus fractures have demonstrated their efficacy to improve shoulder joint mobility, diminish pain and improve functional state [10, 11].

Immobilisation time between the fracture and the beginning of rehabilitation is a parameter that has a significant influence on conservative treatment outcome [10‐12], and, in reality, varies greatly between cases. A recent randomised clinical trial (RCT) [12] addressed the question of the efficacy of an immediate versus delayed mobilisation, showing that patients with a shorter immobilisation time (1 week) recovered faster functionally than patients with a longer immobilisation time. A similar study demonstrated that, in addition to a faster functional recovery, an immediate rehabilitation following the fracture leads to experiencing less pain for the patient [11]. Another study even claimed that a 3-day immobilisation, followed by passive mobilisation is sufficient and safe to restore physical capacities and post-fracture performance [10]. Finally, a RCT has compared the difference between the efficacy of a conventional physical therapy treatment and an individual in-home training program with instructions [13]. The results demonstrated no significant difference between treatment types. Interestingly, advantages emerged in the individual approach with instructions, such as: 1) allowing the patient to stay at home while receiving their rehabilitation, eliminating the need to travel to a clinic, and 2) patient satisfaction derived from having the responsibility of their rehabilitation at home.

Presently, in Canada, rehabilitation for proximal humerus fractures occurs at the hospital (37.2 %) [14], in external clinics, and in various in-home services. However, not all patients have access to rehabilitation services, mainly due the difficulty of the elderly to travel to the clinic because of their precarious health condition [15]. Therefore, new service delivery strategies are essential to enhance accessibility to rehabilitation services, with a focus on in-home services. Telerehabilitation, defined as a telehealth application that uses telecommunication technologies to provide physical therapy services [16‐19], is an interesting solution to the lack of available services. This approach allows the patient to receive rehabilitation at home, without the need for a health care professional to travel to the patient’s home or to travel to the clinic for the patient. As such, telerehabilitation could permit the elderly with a proximal humerus fracture to have access to rehabilitation directly in their home with adequate and safe supervision. Services provided by telerehabiliation can be very diverse, including telecheckups (phone calls to ensure the wellness of the patient), telemonitoring (record physiological data), teleconsultation (between two service centers) and teletreatment [19, 20]. This long-distance therapeutic intervention also includes the notion of frequency (a set number of sessions per week) and duration (over a specific time period) [21, 22].

A systematic review of telerehabilitation interventions [18] showed a tendency for these services to generate clinical improvements that are generally equal to those resulting from conventional rehabilitation programs. For example, efficacy of teletreatment has been demonstrated: in older populations with loss of autonomy [23], or living at home will mild to moderate dementia [24]; in individuals with mobility impairments [25]; and following total knee [26‐29] or shoulder [30] arthroplasty. Interestingly, in the latest study [30], rehabilitation treatment was provided to 10 elderly patients through a videoconferencing system installed directly in their home. The intervention period length was 2 months and included supervised sessions, where a physical therapist was able to adapt exercises according to each patient’s evolution. Results of this study demonstrated that patients are able to adhere to teletreatment, and that they are able to maintain a good relationship with their physical therapists even though there was no direct physical interaction. Moreover, this remote method of receiving their rehabilitation facilitated their daily living since they were not required to travel to receive treatment. By staying home, patient motivation increased and they felt more independent in their exercises. However, an important limitation to this study was the lack of evaluation of clinical results. Therefore, although a promising avenue for rehabilitation, especially in older populations, the efficacy and functional results of telerehabilitation remain to be studied with high quality evaluations.

To our knowledge, only one study exists on telerehabilitation among patients with a proximal humerus fracture [31]. This study, realised by our research team, demonstrated the feasibility of such a service delivery to this specific population. However, our previous study was more focussed on proof-of-principle, and as such, the lack of a control group (treatment at clinic) did not permit us to affirm that clinical improvement was due to the patient’s natural recovery or to the telerehabilitation received. Thus, the main objective of the present study is to evaluate the efficacy of in-home telerehabilitation (TELE group) compared to the conventional rehabilitation in a clinic (CLINIC group) in a population with a proximal humerus fracture. Our hypothesis is that in-home telerehabilitation will prove to be a good alternative to conventional rehabilitation.

This trial is the next logical step to the feasibility study conducted by our research team on 12 post-proximal humerus facture patients [31]. The previous study demonstrated that telerehabilitation seems to be a promising avenue to provide rehabilitation services to this population without adverse events. The results obtained following the present protocol will affirm the cost-efficacy of telereahabilitation treatment in an orthopaedic context, more precisely, after a proximal humerus fracture treated conservatively.

In order to control a potential selection bias, randomisation will be blind to the evaluator and participants’ characteristics will be compared pre-intervention between each group. If a group differs on some characteristics despite randomisation, corrective measures will be made in subsequent analyses. Furthermore, information bias will be controlled by using standardized measures and by calibrating all the assessors for each assessment.

This study will verify the noninferiority of in-home telerehabilitation compared to face-to-face intervention at a clinic for patients with proximal humerus fracture. In accordance with our hypothesis, we think that telerehabilitation will improve access to a rapid, less expensive, satisfactory and effective rehabilitation services.