UMIN-CTR Clinical Trial

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
Email	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
Email	sumiko-y@iuhw.ac.jp

Sponsor
Institute	International University of Health & Welfare
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032197