Safety, Feasibility and Efficacy of Lokomat(®) and Armeo(®)Spring Training in Deconditioned Paediatric, Adolescent and Young Adult Cancer Patients

SIMPLE SUMMARY: Robot-based training is a field of study which aims to understand and augment rehabilitation through the use of robotic orthotics. This study aimed to assess the safety, feasibility and efficacy of rehabilitation robotics in children, adolescents and young adults (AYAs) during or soon after cancer treatment. Cancer patients with significant musculoskeletal, neurological, gait and/or upper limb deficiencies were recruited. Robotic devices utilised real-time biofeedback and computer games to engage participants. 76% completed the 6-week intervention with an overall adherence of 83%. The mean participant satisfaction score was 8.8/10. Fourty-nine adverse events were recorded throughout the course of the study, and no adverse event led to withdrawal from the study. Results suggest that robot-based rehabilitation is safe and feasible for use in children and AYAs who are currently undergoing or recently completed cancer therapy. Preliminary efficacy results indicate large beneficial effects on functional and patient-reported outcomes. ABSTRACT: Background: Rehabilitation robotics is a field of study which aims to understand and augment rehabilitation through the use of robotics devices. Objective: This proof of concept study aimed to test the safety (no. adverse events, incidence of infection), feasibility (program demand, adherence, participant satisfaction) and efficacy (Peak Oxygen uptake (VO(2peak)), 6-min walk test, gait speeds, Canadian Occupational Performance Measure, quality of life) of Lokomat(®) and Armeo(®)Spring training in children and adolescents and young adults (AYAs) during or soon after cancer treatment. Method: This was a 6-week single arm pre-post study. Cancer patients with significant musculoskeletal, neurological, gait and/or upper limb deficiency aged 5 to 25 years were recruited. The rehabilitation program included access to two robotic orthoses: the Lokomat(®) and/or Armeo(®)Spring. Robotic devices utilised real-time biofeedback and computer games to engage and guide participants through a repetitive functional range of movement aimed at improving functional deficiencies. Progressive increases in exercise intensity and duration were encouraged. Results: Twentey-eight participants were approached for study; twenty-one consented. Seventy-six percent completed the six-week intervention with an overall adherence of 83%. The mean participant satisfaction score was 8.8/10. Forty-nine adverse events were recorded throughout the course of the study, forty-five grade 1, three grade 2 and one grade 3. No adverse events led to withdrawal from the study. Preliminary efficacy results indicate large beneficial effects on VO(2peak) (r = 0.63), 10 m comfortable pace walk (r = 0.51) and maximal pace walk (r = 0.60), 6-min walk test (r = 0.60), maximal back and leg strength (r = 0.71), trunk flexibility (r = 0.60), The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) (r = 0.61), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT F) r = 0.53 and the Canadian Occupational Performance Measure, satisfaction (r = 0.88) and performance scores (r = 0.83), and moderate beneficial effects on Leisure Score Index (LSI) (r = 0.30). Conclusion: Our results suggest that Lokomat(®) and Armeo(®)Spring training is safe and feasible for use in children and AYAs who are currently undergoing or have recently completed cancer therapy. A larger controlled trial investigating the efficacy of robotics rehabilitation in this cohort is warranted.