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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033186
Receipt No. R000037574
Scientific Title The influence of plantarflexion resistance of a knee-ankle-foot orthosis on muscle activity during manual-assisted gait in stroke patients with severe hemiparesis
Date of disclosure of the study information 2018/06/29
Last modified on 2019/11/27

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Basic information
Public title The influence of plantarflexion resistance of a knee-ankle-foot orthosis on muscle activity during manual-assisted gait in stroke patients with severe hemiparesis
Acronym The influence of plantarflexion resistance of a knee-ankle-foot orthosis on muscle activity in hemiparetic gait
Scientific Title The influence of plantarflexion resistance of a knee-ankle-foot orthosis on muscle activity during manual-assisted gait in stroke patients with severe hemiparesis
Scientific Title:Acronym The influence of plantarflexion resistance of a knee-ankle-foot orthosis on muscle activity in hemiparetic gait
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of plantarflexion resistance of a knee-ankle-foot orthosis on muscle atitivities, kinematic gait parameters during manual-assisted gait in stroke patients with severe hemiparesis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle activities in gluteus medius, rectus femoris, semitendinosus, tibialis anterior, and medial gastrocnemius on the paretic side during stance phase of gait
Key secondary outcomes An angle and the angular jerk for ankle joint in loading response phase, step length during gait, gait speed, temporal gait cycle parameters

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Manual-assisted gait training using a knee-ankle-foot orthosis with plantarflexion resistance
Interventions/Control_2 Manual-assisted gait training using a knee-ankle-foot orthosis with plantarflexion stop
Interventions/Control_3 Manual-assisted gait training using a knee-ankle-foot orthosis with free plantarflexion
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) First-ever unilateral supratentorial stroke undergoing inpatient rehabilitation
2) Medically stable condition
3) Required continuous physical-assistance during ambulation (the Functional Ambulation Categories <=1)
4) Severe weakness of the paretic lower-extremity (the Motricity Index score <=29)
Key exclusion criteria 1) Symptomatic cardiac, musculoskeletal, or neurological conditions other than stroke
2) Unable to understand the instructions because of communication or cognitive problems
3) Moderate-to-severe pushing behavior while manual-assisted walking (the Burke Lateropulsion Scale walking subscore >=2)
4) Disagreement to participate in the study
Target sample size 21

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Shimizu
Organization Fujioka General Hospital
Division name Department of Rehabilitation Medicine
Zip code 375-8503
Address 813-1 Nakakurisu, Fujioka, Gunma, Japan
TEL 0274-22-3311
Email rehab-pt@fujioka-hosp.or.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Isho
Organization Fujioka General Hospital
Division name Rehabilitation Center
Zip code 375-8503
Address 813-1 Nakakurisu, Fujioka, Gunma, Japan
TEL 0274-22-3311
Homepage URL
Email rehab-pt@fujioka-hosp.or.jp

Sponsor
Institute Fujioka General Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fujioka General Hospital
Address 813-1 Nakakurisu, Fujioka, Gunma, Japan
Tel 0274-22-3311
Email rehab-pt@fujioka-hosp.or.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
2018 Year 06 Month 29 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
Results
Results date posted
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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 28 Day
Date of IRB
2018 Year 06 Month 27 Day
Anticipated trial start date
2018 Year 07 Month 02 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 28 Day
Last modified on
2019 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037574

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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