This protocol describes a multicentre randomised controlled trial conducted across eight spinal cord injury (SCI) centres and 15 rehabilitation centres in Germany. The trial targets adults with chronic SCI and residual motor function in the lower extremities. Baseline examinations are performed at the recruiting SCI centres prior to randomisation at the rehabilitation centres.
The primary objective is to demonstrate the superiority of neuromuscular feedback therapy delivered using an exoskeleton compared with conventional therapy for improving walking ability in patients with chronic complete or incomplete SCI who have remaining lower-extremity motor function. The protocol frames improvement in walking capacity as the key clinical benefit under investigation.
The study plans to include 180 patients with chronic SCI (complete or incomplete) who retain some motor function in the lower extremities. Further inclusion and exclusion criteria were defined in the protocol but are not detailed in the source summary provided.
After baseline assessment at the recruiting SCI centres, participants are randomised in a 1:1 ratio at the rehabilitation centres to either the intervention group (exoskeleton therapy) or the control group (conventional therapy). Randomisation procedures, concealment methods, and stratification factors were referenced in the full protocol but are not reported in the summary.
The intervention arm receives Hybrid Assistive Limb therapy, described as neuromuscular feedback therapy using an exoskeleton. The control arm receives standard conventional therapy as delivered in the participating rehabilitation centres. Both treatments are intended to be comparable in duration and frequency to isolate the effect of the exoskeleton-based feedback approach.
Both intervention and control therapies are delivered five times per week for 60 minutes per session over a 12-week intervention period at the rehabilitation centres. This parity in scheduling is designed to control for therapy dose while comparing modality-specific effects.
The primary outcome is a therapy response defined as a clinically relevant improvement in at least one of the following walking measures:
Secondary endpoints include measures of quality of life, pain, and bladder and bowel function. The exact definitions of what constitutes a “relevant improvement” for each primary measure were specified in the trial protocol but are not reported in the summary provided.
Primary and secondary outcomes after the 12-week intervention phase are assessed by blinded observers at the SCI centres or collected via a patient app. The effects of the intervention are evaluated at an intermediate time point and again at the end of a 6-month follow-up period. Blinding of outcome assessors is specified for endpoint measurement; details on assessor training and app data collection procedures are in the full protocol but not included in the summary.
The study received ethics approval from the ethics committee of the Medical Association of Westphalia-Lippe (register no. 2025 - 2014 f-S). Participants were informed about the aims and procedures and provided written informed consent. The protocol adheres to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement for trial design and reporting.
The investigators commit to publishing trial results in accordance with the CONSORT statement regardless of outcome direction. Datasets produced by the trial belong to the Joint Federal Committee of Germany and are available from that committee on request. The trial is registered under DRKS 00035487.
Note: The source summary provides the key design, intervention, endpoints, and governance details but does not include full eligibility criteria, randomisation technicalities, sample size justification, statistical analysis plan, or precise thresholds for clinically relevant improvement; these details are contained in the full protocol referenced by the study registration.