UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028126 |
|---|---|
| Receipt number | R000032197 |
| Scientific Title | Effect of dorsiflexion resistance of an ankle foot orthosis on the gait of stroke patients in recovery phase |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2022/06/14 16:11:43 |
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Basic information
Public title
Effect of dorsiflexion resistance of an ankle foot orthosis on the gait of stroke patients in recovery phase
Acronym
Effect of dorsiflexion resistance of an ankle foot orthosis on the gait of stroke patients in recovery phase
Scientific Title
Effect of dorsiflexion resistance of an ankle foot orthosis on the gait of stroke patients in recovery phase
Scientific Title:Acronym
Effect of dorsiflexion resistance of an ankle foot orthosis on the gait of stroke patients in recovery phase
Region
| Japan |
Condition
Condition
Cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To know the effect of dorsiflexion resistance of an AFO on the gait of stroke patients in recovery phase
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Gait speed before and after 2week gait training using AFOs
Key secondary outcomes
Kinematic and kinetic parameters in gait before and after 2week gait training using AFOs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Plastic AFO without mechanical ankle joint
Gait training using an AFO by physio-therapists onece a day for 1 hour for 2 weeks
Interventions/Control_2
Plastic AFO with mechanical ankle joint with an oil damper
Gait training using an AFO by physio-therapists onece a day for 1 hour for 2 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke patients
Less than 6 months since onset
Taking rehabilitation program at a hospital
Having gait training by physio therapists using AFOs
Key exclusion criteria
Difficulty to understand oral instruction
Expected to disuse of an AFO in 2 weeks
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sumiko |
| Middle name | |
| Last name | Yamamoto |
Organization
International University of Health & Welfare
Division name
Graduate school
Zip code
107-8402
Address
4-1-26, Akasaka, Minato-ku, Tokyo, Japan
TEL
03-5574-3874
sumiko-y@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Sumiko |
| Middle name | |
| Last name | Yamamoto |
Organization
International University of Health & Welfare
Division name
Graduate school
Zip code
107-8402
Address
4-1-26, Akasaka, Minato-ku, Tokyo, Japan
TEL
03-5574-3874
Homepage URL
sumiko-y@iuhw.ac.jp
Sponsor or person
Institute
International University of Health & Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nakaizu Rehabilitation Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health & Welfare
Address
4-1-26, Akasaka , Minato-ku, Tokyo, Japan
Tel
03-5574-3900
rinri-tky@iuhw.ac.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
農協共済中伊豆リハビリテーションセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
DOI10.1186/s12984-022-01027-1
Publication of results
Published
Result
URL related to results and publications
DOI10.1186/s12984-022-01027-1
Number of participants that the trial has enrolled
36
Results
Seventeen patients in the AFO-OD group and 19 in the nonarticulated AFO group were compared. The ankle joint was more dorsiflexed in paretic stance phase in AFO-OD group. Peak power absorption of the ankle joint in single stance was significantly larger in AFO-OD group(p=0.007) but showed wide variation. There was no significant difference in the peak power generation in preswing or in spatial or temporal parameters, ground reaction force, or shank-to-vertical angle between the two groups.
Results date posted
| 2022 | Year | 01 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 27 | Day |
Baseline Characteristics
Patients with stroke in recovery phase
Participant flow
Patients with stroke in recovery phase was randomly allocated to 2groups, AFO with oil damper group and nonarticulated AFO group. After the measurement of gait without an AFO patients took gait training using each AFO by physiotherapists for 2weeks. The gait with each AFO was measured at the end of gait training.
Adverse events
None
Outcome measures
ankle joint angle and power during gait
Spacio-temporal parameters
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 07 | Day |
Last modified on
| 2022 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032197
