Trial reportOperative Orthopadie und Traumatologie2017
[Foot drop treatment by implantation of a neuroprosthesis (ActiGait®)].
Trial report in Operative Orthopadie und Traumatologie, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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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.
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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.
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Who cites it
1 citing paper in PubMed, 1 citations in OpenAlex.
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Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveGait improvement by restoring dorsiflexion using a neuroprosthesis implant. INDICATIONS: Foot drop with damage to the 1st motor neuron; passive mobility in ankle is possible; adult patients. CONTRAINDICATIONS: Foot drop with peripheral damage and injury to the peroneal nerve; already implanted stimulators (e.g., defibrillator, pacemaker, or pain stimulator); severe anesthesia risks in multimorbid patients. SURGICAL TECHNIQUE: Surgery in lateral position. Searching for the peroneal nerve after dorsal incision in the popliteal fossa, using the medial edge of the biceps femoris as anatomic landmark. After identification of the motor branch of the peroneal nerve by positive dorsiflexion after using electrostimulation apply the electrode cuff on the nerve. Epifascial implantation of stimulation body lateral at the middle third of the thigh over the tractus iliotibialis. POSTOPERATIVE MANAGEMENT: Pain-adapted full weight bearing, no knee flexion more than 90° for 4-6 weeks, activation of neuroprosthesis 3 weeks after surgery, physiotherapy with gait training is required.
resultsBetween 2013 and 2015, implantation of the neuroprosthesis was performed in 21 patients (13 men/8 women) with chronic foot drop due to a central lesion. Significant improvement in walking speed measured with the 10 meter walk test (11.8 ± 5.4 s to 7.9 s ± 3.4; p = 0.007), in gait endurance with 6 min walk test (212.2 ± 75.5 m to 306.4 ± 96.4 m; p ≤ 0.001), and in gait performance using the Emory Functional Ambulation Profile (105.9 ± 49.7 s to 63.2 ± 31. 3 s; p ≤ 0.001). No patient required surgical revision. Postoperative bleeding was recorded in one case (4%). Patient satisfaction and improvement in mobility and quality of life could be achieved (95% and 90%, respectively).
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