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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017012
Receipt No. 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 2017/10/02

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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
Email 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
Email yoshioka@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba Hospital
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2015 Year 04 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 02 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
2015 Year 04 Month 01 Day
Last modified on
2017 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019730

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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