Safety and Efficacy of At-Home Robotic Locomotion Therapy in Individuals with Chronic Incomplete Spinal Cord Injury: A Prospective, Pre-Post Intervention, Proof-of-Concept Study
Identifieur interne : 000585 ( Main/Merge ); précédent : 000584; suivant : 000586Safety and Efficacy of At-Home Robotic Locomotion Therapy in Individuals with Chronic Incomplete Spinal Cord Injury: A Prospective, Pre-Post Intervention, Proof-of-Concept Study
Auteurs : Rüdiger Rupp [Allemagne] ; Daniel Schlie Mann [Allemagne] ; Harry Plewa [Allemagne] ; Christian Schuld [Allemagne] ; Hans Jürgen Gerner [Allemagne] ; Norbert Weidner [Allemagne] ; Eberhard P. Hofer [Allemagne] ; Markus Knestel [Allemagne]Source :
- PLoS ONE [ 1932-6203 ] ; 2015.
Abstract
The compact
Prospective, pre-post intervention, proof-of-concept study to test the feasibility of an unsupervised home-based application of five MoreGait prototypes in subjects with incomplete spinal cord injury (iSCI).
Twenty-five (5 tetraplegia, 20 paraplegia) participants with chronic (mean time since injury: 5.8 ± 5.4 (standard deviation, SD) years) sensorimotor iSCI (7 ASIA Impairment Scale (AIS) C, 18 AIS D; Walking Index for Spinal Cord Injury (WISCI II): Interquartile range 9 to 16) completed the training (45 minutes / day, at least 4 days / week, 8 weeks). Baseline status was documented 4 and 2 weeks before and at training onset. Training effects were assessed after 4 and 8 weeks of therapy.
After therapy, 9 of 25 study participants improved with respect to the dependency on walking aids assessed by the WISCI II. For all individuals, the short-distance walking velocity measured by the 10-Meter Walk Test showed significant improvements compared to baseline (100%) for both self-selected (Mean 139.4% ± 35.5% (SD)) and maximum (Mean 143.1% ± 40.6% (SD)) speed conditions as well as the endurance estimated with the six-minute walk test (Mean 166.6% ± 72.1% (SD)). One device-related adverse event (pressure sore on the big toe) occurred in over 800 training sessions.
Home-based robotic locomotion training with MoreGait is feasible and safe. The magnitude of functional improvements achieved by MoreGait in individuals with iSCI is well within the range of complex locomotion robots used in hospitals. Thus, unsupervised MoreGait training potentially represents an option to prolong effective training aiming at recovery of locomotor function beyond in-patient rehabilitation.
German Clinical Trials Register (DKRS)
Url:
DOI: 10.1371/journal.pone.0119167
PubMed: 25803577
PubMed Central: 4372343
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PMC:4372343Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Safety and Efficacy of At-Home Robotic Locomotion Therapy in Individuals with Chronic Incomplete Spinal Cord Injury: A Prospective, Pre-Post Intervention, Proof-of-Concept Study</title><author><name sortKey="Rupp, Rudiger" sort="Rupp, Rudiger" uniqKey="Rupp R" first="Rüdiger" last="Rupp">Rüdiger Rupp</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Schlie Mann, Daniel" sort="Schlie Mann, Daniel" uniqKey="Schlie Mann D" first="Daniel" last="Schlie Mann">Daniel Schlie Mann</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Plewa, Harry" sort="Plewa, Harry" uniqKey="Plewa H" first="Harry" last="Plewa">Harry Plewa</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Schuld, Christian" sort="Schuld, Christian" uniqKey="Schuld C" first="Christian" last="Schuld">Christian Schuld</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Gerner, Hans Jurgen" sort="Gerner, Hans Jurgen" uniqKey="Gerner H" first="Hans Jürgen" last="Gerner">Hans Jürgen Gerner</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Weidner, Norbert" sort="Weidner, Norbert" uniqKey="Weidner N" first="Norbert" last="Weidner">Norbert Weidner</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Hofer, Eberhard P" sort="Hofer, Eberhard P" uniqKey="Hofer E" first="Eberhard P." last="Hofer">Eberhard P. Hofer</name><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>Ulm University, Institute of Measurement, Control and Microtechnology, Ulm, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Ulm University, Institute of Measurement, Control and Microtechnology, Ulm</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Ulm</settlement></placeName></affiliation></author><author><name sortKey="Knestel, Markus" sort="Knestel, Markus" uniqKey="Knestel M" first="Markus" last="Knestel">Markus Knestel</name><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>Ulm University, Institute of Measurement, Control and Microtechnology, Ulm, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Ulm University, Institute of Measurement, Control and Microtechnology, Ulm</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Ulm</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25803577</idno><idno type="pmc">4372343</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4372343</idno><idno type="RBID">PMC:4372343</idno><idno type="doi">10.1371/journal.pone.0119167</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">000278</idno><idno type="wicri:Area/Pmc/Curation">000278</idno><idno type="wicri:Area/Pmc/Checkpoint">000355</idno><idno type="wicri:Area/Ncbi/Merge">003792</idno><idno type="wicri:Area/Ncbi/Curation">003792</idno><idno type="wicri:Area/Ncbi/Checkpoint">003792</idno><idno type="wicri:Area/Main/Merge">000585</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Safety and Efficacy of At-Home Robotic Locomotion Therapy in Individuals with Chronic Incomplete Spinal Cord Injury: A Prospective, Pre-Post Intervention, Proof-of-Concept Study</title><author><name sortKey="Rupp, Rudiger" sort="Rupp, Rudiger" uniqKey="Rupp R" first="Rüdiger" last="Rupp">Rüdiger Rupp</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Schlie Mann, Daniel" sort="Schlie Mann, Daniel" uniqKey="Schlie Mann D" first="Daniel" last="Schlie Mann">Daniel Schlie Mann</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Plewa, Harry" sort="Plewa, Harry" uniqKey="Plewa H" first="Harry" last="Plewa">Harry Plewa</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Schuld, Christian" sort="Schuld, Christian" uniqKey="Schuld C" first="Christian" last="Schuld">Christian Schuld</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Gerner, Hans Jurgen" sort="Gerner, Hans Jurgen" uniqKey="Gerner H" first="Hans Jürgen" last="Gerner">Hans Jürgen Gerner</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Weidner, Norbert" sort="Weidner, Norbert" uniqKey="Weidner N" first="Norbert" last="Weidner">Norbert Weidner</name><affiliation wicri:level="3"><nlm:aff id="aff001"><addr-line>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Heidelberg University Hospital, Spinal Cord Injury Center, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Hofer, Eberhard P" sort="Hofer, Eberhard P" uniqKey="Hofer E" first="Eberhard P." last="Hofer">Eberhard P. Hofer</name><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>Ulm University, Institute of Measurement, Control and Microtechnology, Ulm, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Ulm University, Institute of Measurement, Control and Microtechnology, Ulm</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Ulm</settlement></placeName></affiliation></author><author><name sortKey="Knestel, Markus" sort="Knestel, Markus" uniqKey="Knestel M" first="Markus" last="Knestel">Markus Knestel</name><affiliation wicri:level="3"><nlm:aff id="aff002"><addr-line>Ulm University, Institute of Measurement, Control and Microtechnology, Ulm, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Ulm University, Institute of Measurement, Control and Microtechnology, Ulm</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Tübingen</region><settlement type="city">Ulm</settlement></placeName></affiliation></author></analytic><series><title level="j">PLoS ONE</title><idno type="eISSN">1932-6203</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="sec001"><title>Background</title><p>The compact <bold>M</bold>otorized orthosis for h<bold>o</bold>me <bold>re</bold>habilitation of <bold>Gait</bold> (MoreGait) was developed for continuation of locomotion training at home. MoreGait generates afferent stimuli of walking with the user in a semi-supine position and provides feedback about deviations from the reference walking pattern.</p></sec><sec id="sec002"><title>Objective</title><p>Prospective, pre-post intervention, proof-of-concept study to test the feasibility of an unsupervised home-based application of five MoreGait prototypes in subjects with incomplete spinal cord injury (iSCI).</p></sec><sec id="sec003"><title>Methods</title><p>Twenty-five (5 tetraplegia, 20 paraplegia) participants with chronic (mean time since injury: 5.8 ± 5.4 (standard deviation, SD) years) sensorimotor iSCI (7 ASIA Impairment Scale (AIS) C, 18 AIS D; Walking Index for Spinal Cord Injury (WISCI II): Interquartile range 9 to 16) completed the training (45 minutes / day, at least 4 days / week, 8 weeks). Baseline status was documented 4 and 2 weeks before and at training onset. Training effects were assessed after 4 and 8 weeks of therapy.</p></sec><sec id="sec004"><title>Results</title><p>After therapy, 9 of 25 study participants improved with respect to the dependency on walking aids assessed by the WISCI II. For all individuals, the short-distance walking velocity measured by the 10-Meter Walk Test showed significant improvements compared to baseline (100%) for both self-selected (Mean 139.4% ± 35.5% (SD)) and maximum (Mean 143.1% ± 40.6% (SD)) speed conditions as well as the endurance estimated with the six-minute walk test (Mean 166.6% ± 72.1% (SD)). One device-related adverse event (pressure sore on the big toe) occurred in over 800 training sessions.</p></sec><sec id="sec005"><title>Conclusions</title><p>Home-based robotic locomotion training with MoreGait is feasible and safe. The magnitude of functional improvements achieved by MoreGait in individuals with iSCI is well within the range of complex locomotion robots used in hospitals. Thus, unsupervised MoreGait training potentially represents an option to prolong effective training aiming at recovery of locomotor function beyond in-patient rehabilitation.</p></sec><sec id="sec006"><title>Trial Registration</title><p>German Clinical Trials Register (DKRS) <ext-link ext-link-type="uri" xlink:href="http://www.drks.de/DRKS00005587">DRKS00005587</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Harkema, Sj" uniqKey="Harkema S">SJ Harkema</name></author><author><name sortKey="Hillyer, J" uniqKey="Hillyer J">J Hillyer</name></author><author><name sortKey="Schmidt Read, M" uniqKey="Schmidt Read M">M Schmidt-Read</name></author><author><name sortKey="Ardolino, E" uniqKey="Ardolino E">E Ardolino</name></author><author><name sortKey="Sisto, Sa" uniqKey="Sisto S">SA Sisto</name></author><author><name sortKey="Behrman, Al" uniqKey="Behrman A">AL 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uniqKey="Craven B">BC Craven</name></author><author><name sortKey="Morris, Ar" uniqKey="Morris A">AR Morris</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Olmos, Le" uniqKey="Olmos L">LE Olmos</name></author><author><name sortKey="Freixes, O" uniqKey="Freixes O">O Freixes</name></author><author><name sortKey="Gatti, Ma" uniqKey="Gatti M">MA Gatti</name></author><author><name sortKey="Cozzo, Da" uniqKey="Cozzo D">DA Cozzo</name></author><author><name sortKey="Fernandez, Sa" uniqKey="Fernandez S">SA Fernandez</name></author><author><name sortKey="Vila, Cj" uniqKey="Vila C">CJ Vila</name></author></analytic></biblStruct></listBibl></div1></back></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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