UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017012 |
|---|---|
| Receipt number | R000019730 |
| Scientific Title | Safety and efficacy of the single joint type of Hybrid Assistive Limb (sj-HAL), a device for any arm and knee joints and specialized in intensive training, on early recovery of knee extension after surgery in patients with osteoarthritis of the knee |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2020/04/16 14:43:39 |
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Basic information
Public title
Safety and efficacy of the single joint type of Hybrid Assistive Limb (sj-HAL), a device for any arm and knee joints and specialized in intensive training, on early recovery of knee extension after surgery in patients with osteoarthritis of the knee
Acronym
Safety and efficacy of the sj-HAL on early recovery of knee extension after surgery in patients with osteoarthritis of the knee
Scientific Title
Safety and efficacy of the single joint type of Hybrid Assistive Limb (sj-HAL), a device for any arm and knee joints and specialized in intensive training, on early recovery of knee extension after surgery in patients with osteoarthritis of the knee
Scientific Title:Acronym
Safety and efficacy of the sj-HAL on early recovery of knee extension after surgery in patients with osteoarthritis of the knee
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation for safety and efficacy of the sj-HAL, on early recovery of knee extension after surgery in patients with osteoarthritis of the knee
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
1. Vital signs (blood pressure, pulse rate and oxyhemoglobin saturation measured by pulse oximetry)
2. Radiological evaluation (X-ray)
3. Satisfaction with the assistance in mobility provided by HAL
4. Amount of time needed to put on and take off the apparatus
5. Adverse events
Key secondary outcomes
1. Active and passive range of motion of the knee
2. Japanese orthopaedic association score for osteoarthritic knees (JOA knee score)
3. Japanese knee osteoarthritis measure (JKOM)
4. Muscle strengh of quadriceps femoris
5. 10-m walking
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants will do a trial fitting of HAL before knee surgery and then conduct exercises with HAL 2 or 3 times a week for about 3 weeks after knee surgery.
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
Subjects must satisfy the following conditions for inclusion:
1. Patients who can be hospitalized continuously along the test schedule.
2. Understand the explanation of the experiment and express consent or refusal.
3. Have a body shape that can be fitted into HAL.
4. Be able to undergo usual physical therapy and occupational therapy.
5. Patients whose knee is straightened worse at 5 to 7 days after surgery rather than at the completion of surgery under anesthesia.
Key exclusion criteria
1. It is difficult to wear HAL or train using HAL due to the severe deformation of the skeletal system.
2. Patients has a complication, which can disturb the treatment using HAL.
3. The biological electrode for HAL can not be affixed to patient's skin due to the skin disease.
4. Patients who take part in other trials within last 12 weeks.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Yamazaki |
Organization
University of Tsukuba
Division name
Department of Orthopaedics Surgery, Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3219
masashiy@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomokazu Yoshioka |
Organization
University of Tsukuba
Division name
Department of Orthopaedics Surgery, Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3219
Homepage URL
yoshioka@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedics Surgery, Faculty of Medicine, University of Tsukuba
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
| 2015 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019730
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