UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002969 |
|---|---|
| Receipt number | 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 20:53:02 |
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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
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
kyeguchi-tkb@umin.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003582
