Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia

Research output: Contribution to journalJournal articlepeer-review

Standard

Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia. / Burridge, Jane H; Haugland, Morten; Larsen, Birgit; Pickering, Ruth M; Svaneborg, Niels; Iversen, Helle Klingenberg; Christensen, P Brøgger; Haase, Jens; Brennum, Jannick; Sinkjaer, Thomas.

In: Journal of Rehabilitation Medicine. Supplement, Vol. 39, No. 3, 04.2007, p. 212-8.

Research output: Contribution to journalJournal articlepeer-review

Harvard

Burridge, JH, Haugland, M, Larsen, B, Pickering, RM, Svaneborg, N, Iversen, HK, Christensen, PB, Haase, J, Brennum, J & Sinkjaer, T 2007, 'Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia', Journal of Rehabilitation Medicine. Supplement, vol. 39, no. 3, pp. 212-8. https://doi.org/10.2340/16501977-0039

APA

Burridge, J. H., Haugland, M., Larsen, B., Pickering, R. M., Svaneborg, N., Iversen, H. K., Christensen, P. B., Haase, J., Brennum, J., & Sinkjaer, T. (2007). Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia. Journal of Rehabilitation Medicine. Supplement, 39(3), 212-8. https://doi.org/10.2340/16501977-0039

Vancouver

Burridge JH, Haugland M, Larsen B, Pickering RM, Svaneborg N, Iversen HK et al. Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia. Journal of Rehabilitation Medicine. Supplement. 2007 Apr;39(3):212-8. https://doi.org/10.2340/16501977-0039

Author

Burridge, Jane H ; Haugland, Morten ; Larsen, Birgit ; Pickering, Ruth M ; Svaneborg, Niels ; Iversen, Helle Klingenberg ; Christensen, P Brøgger ; Haase, Jens ; Brennum, Jannick ; Sinkjaer, Thomas. / Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia. In: Journal of Rehabilitation Medicine. Supplement. 2007 ; Vol. 39, No. 3. pp. 212-8.

Bibtex

@article{f256bf884d5e419f9954905ed99c4f94,
title = "Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia",
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.",
keywords = "Aged, Electric Stimulation Therapy, Electrodes, Implanted, Female, Follow-Up Studies, Foot, Gait, Hemiplegia, Humans, Male, Middle Aged, Safety, Stroke, Walking",
author = "Burridge, {Jane H} and Morten Haugland and Birgit Larsen and Pickering, {Ruth M} and Niels Svaneborg and Iversen, {Helle Klingenberg} and Christensen, {P Br{\o}gger} and Jens Haase and Jannick Brennum and Thomas Sinkjaer",
year = "2007",
month = apr,
doi = "10.2340/16501977-0039",
language = "English",
volume = "39",
pages = "212--8",
journal = "Scandinavian Journal of Rehabilitation Medicine",
issn = "1650-1969",
publisher = "Taylor & Francis",
number = "3",

}

RIS

TY - JOUR

T1 - Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia

AU - Burridge, Jane H

AU - Haugland, Morten

AU - Larsen, Birgit

AU - Pickering, Ruth M

AU - Svaneborg, Niels

AU - Iversen, Helle Klingenberg

AU - Christensen, P Brøgger

AU - Haase, Jens

AU - Brennum, Jannick

AU - Sinkjaer, Thomas

PY - 2007/4

Y1 - 2007/4

N2 - 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.

AB - 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.

KW - Aged

KW - Electric Stimulation Therapy

KW - Electrodes, Implanted

KW - Female

KW - Follow-Up Studies

KW - Foot

KW - Gait

KW - Hemiplegia

KW - Humans

KW - Male

KW - Middle Aged

KW - Safety

KW - Stroke

KW - Walking

U2 - 10.2340/16501977-0039

DO - 10.2340/16501977-0039

M3 - Journal article

C2 - 17468789

VL - 39

SP - 212

EP - 218

JO - Scandinavian Journal of Rehabilitation Medicine

JF - Scandinavian Journal of Rehabilitation Medicine

SN - 1650-1969

IS - 3

ER -

ID: 128983360