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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024020
Receipt No. R000027660
Scientific Title Usefulness of the robot suit HAL in therapy after the hip and knee joint surgery
Date of disclosure of the study information 2016/09/12
Last modified on 2016/09/12

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Basic information
Public title Usefulness of the robot suit HAL in therapy after the hip and knee joint surgery
Acronym Usefulness of the robot suit HAL in therapy
Scientific Title Usefulness of the robot suit HAL in therapy after the hip and knee joint surgery
Scientific Title:Acronym Usefulness of the robot suit HAL in therapy
Region
Japan

Condition
Condition Osteoarthritis of the hip
Osteoarthritis of the knee
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of HAL introduced in physical therapy after surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gait analysis machine: the single support time rate, double support time rate, pace, walking speed
To evaluate the above items postoperative 1 week, 2 weeks, 3 weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Physiotherapy by HAL is, three times a week, for three weeks (all nine times), once about 1 hour
Interventions/Control_2 Control group: implementation only normal physical therapy
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 One side THA planned patients (age 80 or less, or more weight 50kg)
- he does not have the symptoms in other joints such as hip, knee
- Preoperative, possible gait analysis of about 5 seconds at no cane walking to
- Preoperative leg length difference is within 1cm
Key exclusion criteria Described in the above
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name DAISUKE SETOGUCHI
Organization Dept. of Orthop. Surg., Fukuoka Univ.
Division name Orthopedics
Zip code
Address 8-19-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, JAPAN
TEL 092-871-6631
Email setoguchi_jichi@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name DAISUKE SETOGUCHI
Organization Dept. of Orthop. Surg., Fukuoka Univ.
Division name Orthopedics
Zip code
Address 8-19-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, JAPAN
TEL 092-871-6631
Homepage URL
Email setoguchi_jichi@yahoo.co.jp

Sponsor
Institute Dept. of Orthop. Surg., Fukuoka Univ.
Institute
Department

Funding Source
Organization Dept. of Orthop. Surg., Fukuoka Univ.
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
Address
Tel
Email

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
2016 Year 09 Month 12 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 12 Day
Last modified on
2016 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027660

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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