UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038694 |
|---|---|
| Receipt number | R000044048 |
| Scientific Title | Effect of rigid ankle foot orthoses and ankle foot orthoses with oil damper plantar-flexion resistance on thorax and pelvis movements of stroke patients during gait |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2022/09/19 10:59:27 |
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Basic information
Public title
Effect of rigid ankle foot orthoses and ankle foot orthoses with oil damper plantar-flexion resistance on thorax and pelvis movements of stroke patients during gait
Acronym
Effect orthoses on thorax and pelvis of stroke gait
Scientific Title
Effect of rigid ankle foot orthoses and ankle foot orthoses with oil damper plantar-flexion resistance on thorax and pelvis movements of stroke patients during gait
Scientific Title:Acronym
Effect of rigid ankle foot orthoses and ankle foot orthoses with oil damper plantar-flexion resistance on thorax and pelvis movements of stroke patients during gait
Region
| Asia(except Japan) |
Condition
Condition
Cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ankle foot orthosis is used to assist hemiplegic walking, the movement of the ankle joint has been set as fixed in the past, but in recent years, an orthosis that can adjust the plantar-flexion resistance has come to be used. Many studies have shown the effects of various orthoses on the movement of the lower limbs during walking, but the effects on the movement of the trunk and pelvis have not been clarified. The purpose of this study is to clarify the effect of orthoses with fixed ankle joint and with the plantar-flexion resistance on the movement of the pelvis and trunk during hemiplegic gait.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
thoracic and pelvic motion during gait
Key secondary outcomes
other kinetic and kinematic parameters(hip, knee, ankle joint motion and COG motion)
Evalutation: age,gender,height,weight,disease, time since onset, paretic side,lower limb Brunnstrom Stage, Trunk Impairment Scale(TIS), Berg Balance Scale (BBS), Functional Ambulation Categories(FAC), Fugle-Meyer Balance
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
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
two weeks of training with rigid ankle foot orthosis by physical therapist
one hour per day
Measure the gait without any AFOs
Interventions/Control_2
two weeks of training with ankle foot orthosis with plantar-flexion resistance by physical therapist
one hour per day
Measure the gait without any AFOs
Interventions/Control_3
two weeks of training with rigid ankle foot orthosis by physical therapist
one hour per day
Measure the gait with RAFOs
Interventions/Control_4
two weeks of training with ankle foot orthosis with plantar-flexion resistance by physical therapist
one hour per day
Measure the gait with plantar-flexion resistance AFOs
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hemiplegic patient Brunnstrom stage 3-5
Onset time within 12 months.
Be able to walk on flat ground using orthosis safely
Patient who have the prescription for ankle foot orthosis
Patients who can obtain written consent from their own involuntary research participation
Age at the time of obtaining consent is 18 to under 80
Key exclusion criteria
a woman who is pregnant or have the plan of pregnant
Those who have orthopedic diseases that affect gait, have difficulty in communicating, have cognitive problems
Target sample size
20
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
TEL
+81-03-5574-3874
Sumiko-y@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | HUA |
| Middle name | |
| Last name | LING |
Organization
International University of Health & Welfare
Division name
Graduate school
Zip code
324-8501
Address
2600-1 Kitakanemaru Otawara Tochigi
TEL
+81-070-2803-0985
Homepage URL
walter0615@163.com
Sponsor or person
Institute
International University of Health & Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health & Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health & Welfare Otawara
Address
2600-1 Kitakanemaru Otawara Tochigi
Tel
+81 0287-24-3000
s-rinri@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
中国リハビリテーション研究センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 01 | 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
34
Results
Twenty-nine patients completed the study. Interactions were found in pelvic rotation angle, change of shank vertical angle (SVA) in stance, and paretic to non-paretic step length, which all were increased in AFO-OD group (p<0.05), the SVA decreased in RAFO group (p<0.05).
The change of SVA in stance was positively correlated with the pelvic rotation in AFO-OD group. At initial contact, pelvic rotation was positively correlated with the thoracic rotation in both groups
Results date posted
| 2022 | Year | 07 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with stroke
Participant flow
Patients with stroke were randomly allocated to undergo 2 weeks of gait training by physiotherapists while wearing a rigid AFO (RAFO) with fixed ankle or an AFO with an oil damper (AFO-OD) that provides plantarflexion resistance and free dorsiflexion. A motion capture system was used for measurements of shod gait without an AFO at baseline and after training with and without the allocated AFO.
Adverse events
None
Outcome measures
Joint angle moment power during gait
Spatio temporal parameters
Pelvic and thoracic angle
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 20 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 06 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 26 | Day |
Last modified on
| 2022 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044048
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