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Robot-assisted training after proximal humeral fracture: a randomised controlled multicentre intervention trial [with consumer summary] |
Kroger I, Nerz C, Schwickert L, Scholch S, Musig J, Studier-Fischer S, Nolte PC, Becker C, Augat P |
Clinical Rehabilitation 2021 Feb;35(2):242-252 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To examine whether robotic-assisted training as a supplement to usual therapy is safe, acceptable and improves function and patient reported outcome after proximal humeral fractures (PHF). DESIGN: Multicentre, assessor-blinded, randomised controlled prospective trial. SETTING: Three different rehabilitation hospitals in Germany. SUBJECTS: In total 928 PHF patients between 35 and 70 years were screened. Forty-eight participants were included in the study (intervention group n = 23; control group n = 25). INTERVENTION: The control group received usual occupational and physiotherapy over three weeks, and the intervention group received additional 12 robot-assisted training sessions at the ARMEO-Spring. MAIN MEASURES: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), the Wolf Motor Function Test-Orthopaedic, active range of motion and grip strength were determined before and after intervention period. The DASH was additionally obtained postal 6 and 13 months following surgery. RESULTS: The mean age of participants was 55 +/- 10 years and was similar in both groups (p > 0.05). The change in DASH as the primary endpoint in the intervention group after intervention was -15 (CI 8 to 22), at follow-up six month -7 (CI -2 to 16) at follow up 13 month -9 (CI 1 to 16); in control group -14 (CI 11 to 18), at follow-up six month -13 (CI 7 to 19) at follow up 13 month -6 (CI -3 to 14). No difference in the change was found between groups (p > 0.05). None of the follow-up time points demonstrated an additional benefit of the robotic therapy. CONCLUSION: The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.
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