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
Study design Multicentre randomised controlled trial. Setting Eight spinal cord injury (SCI) centres and 15 rehabilitation centres in Germany. Objectives 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. Methods 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 (5x/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. Ethics and dissemination 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. Trial reg
Clinical relevance
Chronic spinal cord injury (SCI) with residual lower extremity motor function represents a clinically significant population for whom optimized rehabilitation strategies remain incompletely defined. This multicentre RCT addresses the evidence gap regarding whether exoskeleton-based neuromuscular feedback therapy (Hybrid Assistive Limb) is superior to conventional therapy in improving walking ability—a functionally critical and patient-prioritized outcome. Given the growing availability of robotic exoskeleton platforms in rehabilitation settings, rigorous comparative efficacy data are urgently needed to guide resource allocation and patient selection.
Key findings
1. Target enrollment is 180 patients with chronic complete or incomplete SCI with residual lower extremity motor function, across 8 SCI centers and 15 rehabilitation centers in Germany, using a 1:1 randomization scheme. 2. The primary endpoint is a composite 'therapy response,' defined as clinically relevant improvement in at least one of three validated measures: the 6-Minute Walk Test (6MWT), the 10-Meter Walk Test (10MWT), or the Walking Index for Spinal Cord Injury II (WISCI-II) score. 3. Both the intervention (Hybrid Assistive Limb exoskeleton therapy) and control (conventional therapy) groups receive equal-intensity treatment: 5 sessions per week, 60 minutes per session, over 12 weeks. 4. Secondary endpoints include quality of life, pain, and bladder and bowel function, assessed by blinded observers at SCI centers or via patient-facing app. 5. Follow-up evaluation is conducted at the midpoint and end of a 6-month post-intervention period, enabling assessment of durability of treatment effects. 6. Quantitative effect sizes, confidence intervals, p-values, and NNT/NNH are not yet available, as this is a published trial protocol; findings are pending completion of the study.
Practice implications
Clinicians should identify patients with chronic SCI who retain residual lower extremity motor function as the target population most likely to be enrolled in or benefit from exoskeleton-assisted rehabilitation trials, and should familiarize themselves with the 6MWT, 10MWT, and WISCI-II as the standard outcome instruments for this population. Until efficacy data from this and similar RCTs are published, exoskeleton-based therapy should be considered investigational rather than standard of care for this indication, and clinical decisions should continue to be guided by individualized functional assessment and available conventional rehabilitation evidence. Rehabilitation centers considering adoption of Hybrid Assistive Limb technology should await the results of this trial, as the structured 5×/week, 60-minute protocol provides a benchmark intensity framework for future implementation if superiority is demonstrated.