Abstract

Study designFeasibility study.ObjectiveTo determine the feasibility of conducting a large trial designed to determine whether the ROBERT® can be used to increase the strength of the hip flexor muscles after spinal cord injury (SCI). The ROBERT® is a robotic device that provides assisted active movement while supporting the weight of the leg. Focus was on recruitment capability, suitability, and acceptability of the intervention and outcome measure.SettingSpecialised SCI centre in Denmark.MethodsAll first-time admitted patients were screened to assess participant recruitment capability. Four people with SCI < 3 months tested a protocol consisting of 60 repetitions of hip flexion in supine conducted with the assistance of the ROBERT® three times a week for 4 weeks. Feasibility was assessed based on adherence to the protocol and completion rate and from the participants’ perspectives. Maximal voluntary contraction (MVC) was accessed at baseline and four weeks.ResultsThe recruitment rate was 8% (7 months). The four participants completed 44 out of 48 sessions (92%). No adverse events occurred. One physiotherapist was required to set-up and supervise each session. The active exercise time varied from 7.5 to 17 min. The participants found the ROBERT® a good supplement to their usual rehabilitation. We were able to measure MVC in even very weak hip flexor muscles with a dynamometer MicroFET2 fixed to a frame.ConclusionThe ROBERT® was feasible and acceptable. The participants perceived it as a supplement, not a replacement to usual physiotherapy. However, recruitment to the study was slow.Trial registrationClinicalTrials.gov NCT05558254. Registered 28th September 2022.

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