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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002969
Receipt No. R000003582
Scientific Title Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS
Date of disclosure of the study information 2010/01/04
Last modified on 2014/04/01

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Basic information
Public title Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS
Acronym Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS
Scientific Title Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS
Scientific Title:Acronym Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS
Region
Japan

Condition
Condition Musculoskeletal ambulation disability symptom complex (MADS) and underlying disorders of MADS
Classification by specialty
Medicine in general Neurology Geriatrics
Pediatrics Orthopedics Neurosurgery
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Quantitative evaluation of temporal improvements in mobility when using HAL and investigation of the feasibility of application of HAL during rehabilitation exercises.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Balancing and walking ability will be evaluated with the Functional Balance Scale, the 10-m walking test, and the 3-m timed up and go test.
Key secondary outcomes 1. Vital signs (heart rate and blood pressure)
2. Severity of the disorder
3. Activities of daily living (Barthel Index)
4. Health-related quality of life (SF-36)
5. Profile of mood states (POMS)
6. Range of motion of the joints in the lower extremities
7. Muscle strength of the major muscles in the lower extremities
8. Rate of perceived exertion (Borg Scale)
9. Muscle action potentials
10. Satisfaction with the assistance in mobility provided by HAL
11. Amount of time needed to put on and take off the apparatus
12. Sabilometry
13. Functional MRI images of the brain
14. Three-dimensional motion analysis
15. Adverse events

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 Maneuver
Interventions/Control_1 Participants will do a trial fitting of HAL 2 or 3 times a week for 2 weeks and then conduct exercises with HAL 2 or 3 times a week for 8 weeks.
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
13 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Subjects must satisfy the following conditions for inclusion:
1. Need assistance from another person or aid in at least one of the following daily activities; standing up, sitting down, and walking.
2. Understand the explanation of the experiment and express consent or refusal. Informed consent will also be obtained from the patient's guardian if the patient is younger than 20 years.
3. Have a body shape that can be fitted into HAL.
4. Be able to undergo usual physical therapy and occupational therapy.
Key exclusion criteria The following patients will be excluded:
1. Patients with inadequately treated cardiovascular disorders.
2. Patients with inadequately treated respiratory disorders.
3. Patients with intellectual impairments that interfere with their understanding of the explanetion of the experiment or instructions they need to follow.
4. Patients with moderate to severe articular problem, including contracture in the lower extremities.
5. Patients with a moderate to severe degree of involuntary movements, ataxia, or impairment of postural reflex in the trunk or lower extremities.
6. Patients with severe spasticity in the lower extremities.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Eguchi
Organization Faculty of Medicine, University of Tsukuba
Division name Division of Clinical Medicine
Zip code
Address 1-1-1 Tennodai Tsukuba-shi, Ibaraki Japan
TEL 029-853-3795
Email kyeguchi-tkb@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoshi Eguchi
Organization Faculty of Medicine, University of Tsukuba
Division name Division of Clinical Medicine
Zip code
Address 1-1-1 Tennodai Tsukuba-shi, Ibaraki Japan
TEL 029-853-3795
Homepage URL
Email kyeguchi-tkb@umin.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Tsukuba Critical Path Research and Education Integrated Leading Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Japan society for the promotion of science

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 筑波大学附属病院(茨城県)
Cyberdyne株式会社社内研究施設(茨城県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Thirty-eight patients with limited mobility were enrolled. The underlying diseases were stroke (n=12), spinal cord disorders (n=8), joint diseases (n=4), and other diseases (n=14). Thirty-two patients completed 16 sessions of training with the HAL. The results of the 10-m walk test included significant improvements in gait speed, number of steps, and cadence. Although improvements were observed in balance ability, as measured with the Timed Up & Go test and Berg Balance Scale, the results were not statistically significant. No serious adverse events were observed during the training.
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 No longer recruiting
Date of protocol fixation
2010 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 03 Day
Last modified on
2014 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003582

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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