Evidence map›Paper›PMID 42538116›Full record

Trial reportBMJ open2026

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.

Mirko Aach, Alexis Brinkemper, Dennis Grasmücke, Angelika Zhivotovskaya, Matthias Königshausen, Thomas A Schildhauer, Christine Uphues, Michael Schäkermann, Marvin Pogoreuz, Anna Mai and 1 more

Abstract readMulticenter StudyRandomized Controlled TrialComparative Study
In one paragraph

Trial report in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Mirko AachDepartment of Spinal Cord Injuries, BG University Hospital Bergmannsheil Bochum, Bochum, Germany.
Alexis BrinkemperDepartment of General and Trauma Surgery, BG University Hospital Bergmannsheil Bochum, Bochum, Germany alexis.brinkemper@bergmannsheil.de.ORCID 0000-0002-8394-8176
Dennis GrasmückeDepartment of Spinal Cord Injuries, BG University Hospital Bergmannsheil Bochum, Bochum, Germany.
Angelika ZhivotovskayaDepartment of Spinal Cord Injuries, BG University Hospital Bergmannsheil Bochum, Bochum, Germany.
Matthias KönigshausenDepartment of General and Trauma Surgery, BG University Hospital Bergmannsheil Bochum, Bochum, Germany.
Thomas A SchildhauerDepartment of General and Trauma Surgery, BG University Hospital Bergmannsheil Bochum, Bochum, Germany.
Christine UphuesClinical Trials Network of the Ruhr University Bochum, Ruhr University Bochum, Bochum, Germany.
Michael SchäkermannClinical Trials Network of the Ruhr University Bochum, Ruhr University Bochum, Bochum, Germany.
Marvin PogoreuzClinical Trials Network of the Ruhr University Bochum, Ruhr University Bochum, Bochum, Germany.
Anna MaiDepartment of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, Germany.
Nina TimmesfeldDepartment of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Bochum, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designMulticentre randomised controlled trial.

settingEight spinal cord injury (SCI) centres and 15 rehabilitation centres in Germany.

objectivesTo 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.

methodsA 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. 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 REGISTRATION NUMBER: DRKS 00035487.

Indexed as

Lower ExtremitySpinal Cord InjuriesAdultChronic DiseaseFemaleGermanyHumansMaleMiddle AgedQuality of LifeRecovery of FunctionResearch DesignTreatment OutcomeWalkingNeuromuscular diseaseREHABILITATION MEDICINESpine

Identifiers

PMID42538116
PMCPMC13435982

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.