Testing neuromuscular feedback therapy in patients with chronic spinal cord injury with residual motor function in the lower extremities compared to 'conventional' therapy: protocol for a multicentre randomised controlled trial.

Abstract

Multicentre randomised controlled trial. Eight spinal cord injury (SCI) centres and 15 rehabilitation centres in Germany. To demonstrate the superiority of neuromuscular feedback therapy using an exoskeleton compared to conventional therapy in terms of improving walking ability in patients with chronic SCI. A total of 180 patients with chronic complete or incomplete SCI and residual motor function in the lower extremities are to be included. Baseline examination will be carried out at the recruiting SCI centres, followed by 1:1 randomisation at the rehabilitation centre allocating patients to the control group (conventional therapy) or the intervention group (Hybrid Assistive Limb therapy). Both interventions take place to the same extent (5×/week, 60 min) over a period of 12 weeks at the rehabilitation centres. After the 12-week intervention phase, the primary (therapy response defined as relevant improvement in at least one of the following: 6 min walk test, 10 m walk test and Walking Index for Spinal Cord Injury II score) and secondary endpoints (quality of life, pain, bladder and bowel function) are recorded by blinded observers at the SCI centres or via patient app. The effects of the intervention will be evaluated in the middle and at the end of the 6-month follow-up period. The study is approved by the ethics committee of the Medical Association of Westphalia-Lippe (register no. 2025-2014 f-S). The participants were informed about the aims and procedures of the study and gave their written consent. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement. The study results will be published in accordance with the Consolidated Standards of Reporting Trials (CONSORT), regardless of whether the results are positive or negative. The datasets belong to the Joint Federal Committee of Germany and are available there on request. DRKS 00035487.