UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024020 |
|---|---|
| Receipt number | 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 20:01:43 |
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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
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
setoguchi_jichi@yahoo.co.jp
Sponsor or person
Institute
Dept. of Orthop. Surg., Fukuoka Univ.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027660
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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