Unique ID issued by UMIN | UMIN000020604 |
---|---|
Receipt number | R000023782 |
Scientific Title | The therapeutic effects of peroneal nerve functional electric stimulation for lower extremity in patients with sub-acute post-stroke hemiplegia: A randomized controlled study(RALLY Study) |
Date of disclosure of the study information | 2016/01/17 |
Last modified on | 2016/08/04 08:41:57 |
The therapeutic effects of peroneal nerve functional electric stimulation for lower extremity in patients with sub-acute post-stroke hemiplegia: A randomized controlled study(RALLY Study)
RALLY study
The therapeutic effects of peroneal nerve functional electric stimulation for lower extremity in patients with sub-acute post-stroke hemiplegia: A randomized controlled study(RALLY Study)
RALLY study
Japan |
Stroke
Rehabilitation medicine |
Others
NO
To invetigate the effects of gait training with functinal electrical stimulation to the improve the lower-limb fuction and ambulation in convalescent stroke patients
Efficacy
6-minute walk test at baseline and ater 8-week intervention
10-m walk test; Fugl-Meyer assessment (FMA); modified Ashworth scale (MAS); range of motion; Timed up and go test (TUG); Stroke Impact Scale (SIS); subjective gait analysis; Patient reported outcome measure (PRO), adverse event
Interventional
Parallel
Randomized
Cluster
Open -but assessor(s) are blinded
Active
2
Treatment
Device,equipment |
Gait training with functional electrical stimulation (FES) + conventional rehabilitation therapy. Intervention with FES is scheduled 40min/day, five times a week, for 8 weeks.
Gait training without functional electrical stimulation (FES) + conventional rehabilitation therapy.
20 | years-old | <= |
85 | years-old | > |
Male and Female
(1) Patinets who agree to participate in this study and provode their informed consent; (2) since after stroke wothin 6 months; (3) stroke type is only intracranial hemorrhage or ischemic stroke; (4) inpatients for the rehabilitation therapy; (5) Functional Ambulation Classification (FAC) is 3 or 4; (6) stable general condition; (7) drop foot in walking
(1) severe heart disease; (2) previous gait disability, such as neurological disease; (3) previous orthopedic disease, such as knee osteoarthritis; (4) severe hepatic or renal dysfunction; (5) severe sensory disturbance or severe ataxia or severe higher brain dysfunction; (6) contraindicated for the electrical stimulation (e.g. patients with a medical implant or implantable medical electrical equipment such as a cardiac pacemaker); (7) severe skin disease; (8) unstable medical condition; (9) patinets whose impairement severlities changed during the study period
200
1st name | |
Middle name | |
Last name | Shuji Matsumoto |
Kagoshima University
Dept. of Rehabilitation
3930-7 Takachiho, Makizono-cho, Kirishima City
0995-78-2538
shushu@m.kufm.kagoshima-u.ac.jp
1st name | |
Middle name | |
Last name | Shuji Matsumoto |
Kagoshima University
Dept. of Rehabilitation
3930-7 Takachiho, Makizono-cho, Kirishima City
0995-78-2538
shushu@m.kufm.kagoshima-u.ac.jp
Kagoshima University
Teijin Pharma Limited
Profit organization
Japan
NO
2016 | Year | 01 | Month | 17 | Day |
Unpublished
2015 | Year | 12 | Month | 12 | Day |
2016 | Year | 08 | Month | 01 | Day |
2016 | Year | 01 | Month | 17 | Day |
2016 | Year | 08 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023782