Neurology · Medical Literature
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.
Clinical relevance
Chronic spinal cord injury (SCI) with residual lower-extremity motor function represents a population with significant unmet rehabilitative need, where optimizing ambulatory recovery can profoundly impact independence and quality of life. This trial addresses the critical evidence gap regarding whether exoskeleton-assisted neuromuscular feedback therapy (Hybrid Assistive Limb, HAL) is superior to conventional physiotherapy for improving walking ability in this cohort. With SCI rehabilitation practice currently lacking high-level RCT evidence to guide technology-assisted gait training decisions, this multicentre protocol is timely and directly relevant to neurorehabilitation specialists.
Key findings
1. Study design: Multicentre, prospective, 1:1 randomised controlled trial across 8 SCI centres and 15 rehabilitation centres in Germany, with a target enrolment of 180 patients with chronic complete or incomplete SCI and residual lower-extremity motor function. 2. Intervention parameters: Both arms receive matched-intensity therapy (5 sessions/week, 60 minutes/session) over 12 weeks; the intervention group uses HAL exoskeleton-based neuromuscular feedback therapy versus conventional rehabilitation in the control group. 3. Primary endpoint: Therapy response defined as a clinically relevant improvement in at least one of three validated ambulatory measures — the 6-Minute Walk Test (6MWT), 10-Metre Walk Test (10MWT), and Walking Index for Spinal Cord Injury II (WISCI-II) — assessed by blinded observers post-intervention. 4. Secondary endpoints: Health-related quality of life, pain, and bladder and bowel function, captured at the SCI centres or via patient-reported app, providing a comprehensive functional and patient-centred outcomes profile. 5. Follow-up and interim analysis: Outcomes are assessed at the end of the 12-week intervention phase and at two timepoints during a 6-month follow-up period, enabling evaluation of durability of any treatment effect. 6. Methodological rigour: The protocol adheres to SPIRIT guidelines, ethics approval is confirmed (Medical Association of Westphalia-Lippe, reg. no. 2025-2014f-S), registered on DRKS (00035487), and full CONSORT-compliant publication is pre-committed regardless of outcome direction — minimising reporting bias.
Practice implications
Clinicians managing chronic SCI patients with residual lower-extremity motor function should be aware that HAL exoskeleton therapy is currently under rigorous RCT evaluation against conventional rehabilitation, and prescribing decisions regarding exoskeleton-assisted gait training should await the superiority data this trial is powered to provide. If superiority of HAL therapy is demonstrated, patient selection criteria — specifically chronic SCI (complete or incomplete) with preserved lower-extremity motor residual function — and a structured 12-week, 5-day/week, 60-minute-per-session protocol would form the evidence-based framework for implementation. In the interim, centres with access to HAL or similar neuromuscular feedback exoskeletons should consider participation in or alignment with this trial, and clinicians should monitor the DRKS 00035487 registry and subsequent CONSORT publication for practice-changing results.