UMIN-CTR Clinical Trial

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