UMIN-CTR Clinical Trial

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
Email	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
Email	walter0615@163.com

Sponsor
Institute	International University of Health & Welfare
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044048