UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052001 |
|---|---|
| Receipt number | R000059353 |
| Scientific Title | Effects of ankle-foot orthosis with functional electrical stimulation intervention on gait disturbance in subacute hemiplegia patients -a series of single case design- |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2025/02/22 23:54:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of ankle-foot orthosis with functional electrical stimulation intervention on gait disturbance in subacute hemiplegia
patients -a series of single case design-
Acronym
Effects of ankle-foot orthosis with functional electrical stimulation intervention on gait disturbance
Scientific Title
Effects of ankle-foot orthosis with functional electrical stimulation intervention on gait disturbance in subacute hemiplegia
patients -a series of single case design-
Scientific Title:Acronym
Effects of ankle-foot orthosis with functional electrical stimulation intervention on gait disturbance
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of ankle-foot orthosis with functional electrical stimulation intervention for gait disturbance in stroke hemiplegia with inadequate ankle dorsiflexion angle while walking.
In addition, a single case design should be implemented for multiple cases to verify the effectiveness of the treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10m walk test(maximum walking speed)
Key secondary outcomes
ankle joint dorsiflexion angle during gait
EMG using electromyography(tibialis anterior,gastrocnemius)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For single cases, interventions will begin with gait practice with ankle-foot orthosis (period A1), transition to gait practice with ankle-foot orthosis plus functional electrical stimulation (period B1), return to gait practice with ankle-foot orthosis (period A2), and transition to gait practice with ankle-foot orthosis plus functional electrical stimulation (period B2). Each phase will consist of seven interventions, one per day
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stroke hemiplegic patients admitted to the Kaifukukirehabilitation ward of Medical Corporation Juryo Kumamoto Kinoh Hospital who meet the following conditions
1)Patients with insufficient ankle dorsiflexion angle during gait (dorsiflexion angle less than 0 degree during gait)
2)Patients receiving orthosis therapy for 1)
3)First seizure cerebral infarction or cerebral hemorrhage
4)More than 1 month to 6 months after onset
5) Patients whose Functional Ambulation Categories (FAC) are
2 (light assistance) or 3 (supervised)
6)No obvious paralytic symptoms or motor deficits on the nonparalytic side
7)Patients who can obtain ankle dorsiflexion movement using functional electrical stimulation
(Patients without peripheral neuropathy such as common peroneal nerve palsy)
Key exclusion criteria
1)Patients contraindicated to functional electrical stimulation(For example patients with a cardiac pacemaker , those with a history of epileptic seizures or those who are expected to have seizures, Persons with metal implants )
2)Patients with cardiovascular disease and at risk for exercise
3)Patients whose ankle dorsiflexion angle has not reached 0 degree with orthokinetic exercise
4)Patients who are unable to understand the study description or cannot appeal for discontinuation of the study on their own in the event of abnormality.
(For example mini mental state examination score: MMSE less than 21 points)
5)Patients under 18 years of age or over 85 years of age
6)Patients with severe sensory disturbance or marked muscle tone (modified Ashworth scale: MAS 3 or higher)
7)Patients who have difficulty understanding instructions or walking independently due to the effects of attention disorders or other cognitive dysfunction
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Sannomiya |
Organization
Medical Corporation Juryo Kumamoto Kinoh Hospital
Division name
Department of Comprehensive Rehabilitation medicine
Zip code
860-0084
Address
6-8-1 Yamamuro Kita-ku,Kumamoto
TEL
096-345-8111
juryopt.teraguchi3175@gamil.com
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Teraguchi |
Organization
Medical Corporation Juryo Kumamoto Kinoh Hospital
Division name
Department of Comprehensive Rehabilitation medicine
Zip code
860-0084
Address
6-8-1 Yamamuro Kita-ku,Kumamoto
TEL
096-345-8111
Homepage URL
juryopt.teraguchi3175@gamil.com
Sponsor or person
Institute
Medical Corporation Juryo Kumamoto Kinoh Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Juryo Kumamoto Kinoh Hospital
Address
6-8-1 Yamamuro Kita-ku,Kumamoto
Tel
096-345-8111
medlab@juryo.or.jp
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
| 2023 | Year | 08 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059353
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/01/29 | 様式01-A 研究計画書（介入研究) ★.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/02/23 | case_teraguchi.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/02/23 | ★シングルケースデザインのデータ処理ファイル case3.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/59353
