UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of the robot suit HAL in therapy after the hip and knee joint surgery
Title of the study (Brief title)	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	DAISUKE SETOGUCHI
Organization	Dept. of Orthop. Surg., Fukuoka Univ.
Division name	Orthopedics
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	DAISUKE SETOGUCHI
Organization	Dept. of Orthop. Surg., Fukuoka Univ.
Division name	Orthopedics
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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