Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia
Research output: Contribution to journal › Journal article › peer-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 journal › Journal article › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
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