UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public 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)
Acronym
RALLY study
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)
Scientific Title:Acronym
RALLY study
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To invetigate the effects of gait training with functinal electrical stimulation to the improve the lower-limb fuction and ambulation in convalescent stroke patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-minute walk test at baseline and ater 8-week intervention
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Gait training with functional electrical stimulation (FES) + conventional rehabilitation therapy. Intervention with FES is scheduled 40min/day, five times a week, for 8 weeks.
Interventions/Control_2
Gait training without functional electrical stimulation (FES) + conventional rehabilitation therapy.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(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
Key exclusion criteria
(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
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Matsumoto |
Organization
Kagoshima University
Division name
Dept. of Rehabilitation
Zip code
Address
3930-7 Takachiho, Makizono-cho, Kirishima City
TEL
0995-78-2538
shushu@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Matsumoto |
Organization
Kagoshima University
Division name
Dept. of Rehabilitation
Zip code
Address
3930-7 Takachiho, Makizono-cho, Kirishima City
TEL
0995-78-2538
Homepage URL
shushu@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharma Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2015 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 17 | Day |
Last modified on
| 2016 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023782
