Unique ID issued by UMIN | UMIN000007685 |
---|---|
Receipt number | R000009062 |
Scientific Title | Effects of combined active pedaling exercise with electrical stimulation on gait disturbance in patients with stroke - A single-blind randomized control study, multicenter trial -. |
Date of disclosure of the study information | 2012/04/15 |
Last modified on | 2015/07/15 12:17:28 |
Effects of combined active pedaling exercise with electrical stimulation on gait disturbance in patients with stroke - A single-blind randomized control study, multicenter trial -.
Effects of combined pedaling exercise with electrical stimulation
Effects of combined active pedaling exercise with electrical stimulation on gait disturbance in patients with stroke - A single-blind randomized control study, multicenter trial -.
Effects of combined pedaling exercise with electrical stimulation
Japan |
Post-stroke patients
Rehabilitation medicine |
Others
NO
To examine effects of combined pedaling exercise with electrical stimulation on gait disturbance in patients with stroke.
Efficacy
Confirmatory
Pragmatic
Phase II,III
10m gait measurement
2 minute or 6 minute walk test, Time up and Go test (TUG), Functional Ambulation Categories (FAC), modified Ashworth scale (MAS), Brunnstrom-stage, Fugl-Meyer assessment, grip strength, knee extension strength, Functional Independence Measure (FIM),
Stroke Impact Scale (SIS)-16
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
3
Treatment
Device,equipment | Maneuver |
Combination of pedaling exercise with electrical stimulation 15min/day for 3weeks.
Combination of pedaling exercise with sham electrical stimulation 15min/day for 3weeks.
Electrical stimulation alone15min/day for 3weeks.
30 | years-old | <= |
80 | years-old | > |
Male and Female
First episode of unilateral hemiparetic stroke occurring within the six-month period prior to enrolment, age between 30 and 75 years, Functional Ambulation Categories13 score greater than 3 (ambulator-dependent for supervision);, modified Ashworth scale14 score greater than 1 (slight increase in muscle tone) for the affected side ankle dorsiflexors, no severe cognitive impairment (Mini-Mental State Examination: MMSE>21
Unstable medical disorder, implanted electronic pacing or defibrillation devices, unstable vital signs, or potentially fatal cardiac arrhythmias. Marked sensory deficit in the affected lower extremity. Fugl-Meyer lower extremity items >32. Gait velocity <57m/min.
60
1st name | |
Middle name | |
Last name | Koki Ikuno |
Nishiyamato Rehabilitaiton Hospital
Department of Rehabilitation Medicine
3238-6, Kanmaki, Kanmaki-cho, Kitakatsuragi-gun, Nara
0745-71-6688
pt.k.ikuno@gmail.com
1st name | |
Middle name | |
Last name | Koki Ikuno |
Nishiyamato Rehabilitaiton Hospital
Department of Rehabilitation Medicine
3238-6, Kanmaki, Kanmaki-cho, Kitakatsuragi-gun, Nara
0745-71-6688
k.ikuno@gmail.com
Nishiyamato Rehabilitaiton Hospital
None
Self funding
Tokyo Bay Rehabilitation Hospital
NO
西大和リハビリテーション病院(奈良県)東京湾岸リハビリテーション病院(千葉県),谷津保健病院(千葉県),協和会病院(大阪府),日野病院(大阪府),角谷リハビリテーション病院(和歌山県)寺下病院(和歌山県),おおくまリハビリテーション病院(兵庫県)
2012 | Year | 04 | Month | 15 | Day |
Unpublished
Completed
2012 | Year | 04 | Month | 01 | Day |
2012 | Year | 04 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2012 | Year | 04 | Month | 06 | Day |
2015 | Year | 07 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009062
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |