Effectiveness of robot-assisted training added to conventional rehabilitation in patients with humeral fracture early after surgical treatment: protocol of a randomised, controlled, multicentre trial

Abstract

BackgroundThe incidence of proximal humeral fractures increases with age. The functional recovery of the upper arm after such fractures is slow, and results are often disappointing. Treatment is associated with long immobilisation periods. Evidence-based exercise guidelines are missing. Loss of muscle mass as well as reduced range of motion and motor performance are common consequences. These losses could be partly counteracted by training interventions using robot-assisted arm support of the affected arm derived from neurorehabilitation. Thus, shorter immobilisation could be reached. Thus far, this approach has been tested in only a few small studies. The aim of the present study is to examine whether assistive robotic training augmenting conventional occupational and physical therapy can improve functional shoulder outcomes.Methods/designPatients aged between 35 and 66 years with proximal humeral fracture and surgical treatment will be recruited at three different clinics in Germany and randomised into an intervention group and a control group. Participants will be assessed before randomisation and followed after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months. The baseline assessment will include cognition (Short Orientation-Memory-Concentration Test); level of pain in the affected arm; ability to work; gait speed (10-m walk); disability of the arm, shoulder and hand (Disabilities of the Arm, Shoulder and Hand Outcome Measure [DASH]); range of motion of the affected arm (goniometer measurement); visual acuity; and motor function of orthopaedic patients (Wolf Motor Function Test–Orthopaedic version [WMFT-O]). Clinical follow-up directly after the intervention will include assessment of disability of the arm, shoulder and hand (DASH) as well as range of motion and motor function (WMFT-O). The primary outcome parameter will be the DASH, and the secondary outcome parameter will be the WMFT-O. The long-term results will be assessed prospectively by postal follow-up. All patients will receive conventional occupational and physical therapy. The intervention group will receive additional robot-assisted training using the Armeo®Spring robot for 3 weeks.DiscussionThis study protocol describes a phase II, randomised, controlled, single-blind, multicentre intervention study. The results will guide and possibly improve methods of rehabilitation after proximal humeral fracture.Trial registrationClinicaltrials.gov, NCT03100201. Registered on 28 March 2017.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2274-z) contains supplementary material, which is available to authorized users.

Inter-rater reliability, sensitivity to change and responsiveness of the orthopaedic Wolf-Motor-Function-Test as functional capacity measure before and after rehabilitation in patients with proximal humeral fractures

“…Due to the funding guidelines of the sponsor of the study (“Deutsche Gesetzliche Unfallversicherung (DGUV)”) only persons up to 69 could be included into the intervention study. This decision is based on the study approach to be able to quickly re-integrate patients after PHF into everyday work [19]. The second group consisted of 40 patients with an age range from 34 to 69 years with surgical treatment after PHF participating in a randomised controlled trail to measure the effectiveness of robot-assisted training added to conventional rehabilitation [19].…”

“…This decision is based on the study approach to be able to quickly re-integrate patients after PHF into everyday work [19]. The second group consisted of 40 patients with an age range from 34 to 69 years with surgical treatment after PHF participating in a randomised controlled trail to measure the effectiveness of robot-assisted training added to conventional rehabilitation [19]. The proximal humeral fractures of both patient groups were surgically fixed by plate osteosynthesis, screw fixation, endoprostheses or humeral nails.…”

An Orthopaedic Robotic-Assisted Rehabilitation Method of the Forearm in Virtual Reality Physiotherapy

“…On the contrary, even if some of the rehabilitation robots reported for neurorehabilitation could have the potential use in orthopaedic rehabilitation, the adopted human-robot interaction schemes and assisted physiotherapy approaches of such systems cannot be directly applied for the needs of orthopaedic patients [ 40 , 41 ]. At most, they should be used with precaution, but in any case, it is not clear if neurorehabilitation approaches would be valid for orthopaedic lesions, given the noticeable different clinical goals [ 41 ].…”

Effects of Virtual Reality-Based Rehabilitation on Burned Hands: A Prospective, Randomized, Single-Blind Study

“…Participants were able to engage with the VR system and complete the interventions without premature withdrawal or non-adherence. A previous study has emphasized the importance of robot-assisted rehabilitation in the acute phase after musculoskeletal injuries and reported that it allowed the patient to mobilize the affected arm early by reducing muscle mass loss and improving motor capacity [22]. Immobilization after burn injuries induces loss of muscle strength and flexibility in adjacent joints.…”