UMIN-CTR Clinical Trial

Basic information
Public title	Changes in muscle activity of ankle plantar fractures during the second half of the walking stance phase in patients with ankle fractures by wearing trunk orthosis with joints providing resistive force
Acronym	Effect of trunk orthosis with joints providing resistive force on gait in patients with ankle fractures
Scientific Title	Changes in muscle activity of ankle plantar fractures during the second half of the walking stance phase in patients with ankle fractures by wearing trunk orthosis with joints providing resistive force
Scientific Title:Acronym	Effect of trunk orthosis with joints providing resistive force on gait in patients with ankle fractures
Region	Japan

Condition
Condition	ankle fractures
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effect of using trunk orthosis with joints providing resistive force alone and in combination with Nordic poles on the gait of postoperative patients with ankle fractures who are allowed to walk with full load.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5-meter walking test Muscle activity of gastrocnemius muscle (surface electromyography)
Key secondary outcomes	pain(visual analog scale)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Trunk Orthosis with joints providing resistive force Nordic Pole
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients after ankle joint fracture surgery Patients who have received permission from their orthopedic surgeon to practice walking with full load Patients who can walk 10m without a walking aid Those who meet the range of motion required for normal walking in the hip joint and ankle joint
Key exclusion criteria	Those who were unable to walk before the fracture Persons with central nervous system disease Persons with contraindications to the use of a Trunk Orthosis with joints providing resistive force
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Kurita Middle name Last name Shinya
Organization	Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital
Division name	Department of Rehabilitation Medicine
Zip code	145-0065
Address	4-5-10 Hhigashiyukugaya,oota-ku,Tokyo
TEL	0357348000
Email	shinya_kurita@tokyo-hmt.jp

Public contact
Name of contact person	1st name Kurita Middle name Last name Shinya
Organization	Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital
Division name	Department of Rehabilitation Medicine
Zip code	145-0065
Address	4-5-10 Hhigashiyukugaya,oota-ku,Tokyo
TEL	0357348000
Homepage URL
Email	shinya_kurita@tokyo-hmt.jp

Sponsor
Institute	Department of Rehabilitation Medicine,Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital
Institute
Department

Funding Source
Organization	No
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	Medicine,Tokyo Metropolitan Health and Hospitals Corporation Ebara Hospital
Address	4-5-10 Hhigashiyukugaya,oota-ku,Tokyo
Tel	0357348000
Email	shinya_kurita@tokyo-hmt.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	2021 Year 01 Month 28 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	12
Results	Only with trunk orthosis with joints providing resistive force, the muscle activity of the lateral head of the affected gastrocnemius improved significantly, and significant improvement in walking speed was observed only after trunk orthosis with joints providing resistive force was worn and removed. No significant improvement was observed in combination with Nordic poles.
Results date posted	2020 Year 12 Month 17 Day
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	Completed
Date of protocol fixation	2019 Year 05 Month 24 Day
Date of IRB	2019 Year 05 Month 28 Day
Anticipated trial start date	2019 Year 10 Month 31 Day
Last follow-up date	2020 Year 08 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 28 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048832