Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia
Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia
Objective: To evaluate a selective implantable drop foot stimulator (ActiGait) in terms of effect on walking and safety.
Design: A phase II trial in which a consecutive sample of participants acted as their own controls.
Subjects: People who had suffered a stroke at least 6 months prior to recruitment and had a drop-foot that affected walking were recruited from 3 rehabilitation centres in Denmark.
Methods: Stimulators were implanted into all participants. Outcome measures were range of ankle dorsiflexion with stimulation and maximum walking speed and distance walked in 4 minutes. Measurements were applied before implantation, at 90 days and at a long-term follow-up assessment. Changes over time and with and without stimulation are reported. Safety was evaluated by nerve conduction velocity and adverse events.
Results: Fifteen participants were implanted and 13 completed the trial. Long-term improvements were detected in walking speed and distance walked in 4 minutes when stimulated, and the orthotic effect of stimulation showed statistically significant improvement. The device did not compromise nerve conduction velocity and no serious device-related adverse events were reported. Technical problems were resolved by the long-term follow-up assessment at which further improvement in walking was observed.
Conclusion: This trial has evaluated the safety and performance of the device, which was well accepted by patients and did not compromise safety.
electrical stimulation, implanted electrodes, rehabilitation, stroke and gait
212-218
Burridge, Jane
0110e9ea-0884-4982-a003-cb6307f38f64
Haugland, Morten
aed8bd7c-c7ce-409d-9619-854aa95954c1
Larsen, Birgit
53a132bd-58f3-43f5-88a3-c2918be7baf4
Pickering, Ruth M.
4a828314-7ddf-4f96-abed-3407017d4c90
Svaneborg, Niels
0bba68ce-a453-4119-8f06-74fb245c8640
Iversen, Helle K.
5b692a44-1522-4d68-a5a2-f989c486e297
Christensen, P. Brøgger
79b9a397-890c-4dc9-8df4-eb111d5d5d59
Haase, Jens
8d93d452-82ec-4e5c-8544-65b489e63a95
Brennum, Jannick
a5d8e947-dfac-4597-9571-2d14545e3763
Sinkjaer, Thomas
155e5daa-2da5-44f6-8ce6-2289233f873c
1 April 2007
Burridge, Jane
0110e9ea-0884-4982-a003-cb6307f38f64
Haugland, Morten
aed8bd7c-c7ce-409d-9619-854aa95954c1
Larsen, Birgit
53a132bd-58f3-43f5-88a3-c2918be7baf4
Pickering, Ruth M.
4a828314-7ddf-4f96-abed-3407017d4c90
Svaneborg, Niels
0bba68ce-a453-4119-8f06-74fb245c8640
Iversen, Helle K.
5b692a44-1522-4d68-a5a2-f989c486e297
Christensen, P. Brøgger
79b9a397-890c-4dc9-8df4-eb111d5d5d59
Haase, Jens
8d93d452-82ec-4e5c-8544-65b489e63a95
Brennum, Jannick
a5d8e947-dfac-4597-9571-2d14545e3763
Sinkjaer, Thomas
155e5daa-2da5-44f6-8ce6-2289233f873c
Burridge, Jane, Haugland, Morten, Larsen, Birgit, Pickering, Ruth M., Svaneborg, Niels, Iversen, Helle K., Christensen, P. Brøgger, Haase, Jens, Brennum, Jannick and Sinkjaer, Thomas
(2007)
Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia.
Journal of Rehabilitation Medicine, 39 (3), .
(doi:10.2340/16501977-0039).
Abstract
Objective: To evaluate a selective implantable drop foot stimulator (ActiGait) in terms of effect on walking and safety.
Design: A phase II trial in which a consecutive sample of participants acted as their own controls.
Subjects: People who had suffered a stroke at least 6 months prior to recruitment and had a drop-foot that affected walking were recruited from 3 rehabilitation centres in Denmark.
Methods: Stimulators were implanted into all participants. Outcome measures were range of ankle dorsiflexion with stimulation and maximum walking speed and distance walked in 4 minutes. Measurements were applied before implantation, at 90 days and at a long-term follow-up assessment. Changes over time and with and without stimulation are reported. Safety was evaluated by nerve conduction velocity and adverse events.
Results: Fifteen participants were implanted and 13 completed the trial. Long-term improvements were detected in walking speed and distance walked in 4 minutes when stimulated, and the orthotic effect of stimulation showed statistically significant improvement. The device did not compromise nerve conduction velocity and no serious device-related adverse events were reported. Technical problems were resolved by the long-term follow-up assessment at which further improvement in walking was observed.
Conclusion: This trial has evaluated the safety and performance of the device, which was well accepted by patients and did not compromise safety.
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More information
Submitted date: 2 May 2006
Published date: 1 April 2007
Keywords:
electrical stimulation, implanted electrodes, rehabilitation, stroke and gait
Identifiers
Local EPrints ID: 49348
URI: http://eprints.soton.ac.uk/id/eprint/49348
ISSN: 1650-1977
PURE UUID: ff8d922d-038f-47ee-853e-ba74fb132ecb
Catalogue record
Date deposited: 31 Oct 2007
Last modified: 16 Mar 2024 02:57
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Contributors
Author:
Morten Haugland
Author:
Birgit Larsen
Author:
Niels Svaneborg
Author:
Helle K. Iversen
Author:
P. Brøgger Christensen
Author:
Jens Haase
Author:
Jannick Brennum
Author:
Thomas Sinkjaer
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