JPRN-jRCTs052230043
Recruiting
N/A
A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device for gait instability in patients with Parkinson's disease. a randomized controlled trial
Kohara Nobuo0 sites30 target enrollmentJune 20, 2023
ConditionsParkinson's disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson's disease
- Sponsor
- Kohara Nobuo
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Those who have been diagnosed with clinically established or clinically probable cases according
- •to the clinical diagnostic criteria for Parkinson's disease by the Movement Disorder Society (MDS).
- •2\)Hoehn\-Yahr Scale stage III
- •3\)Those who have not changed the type and dos e of Parkinson's drug before 4 weeks of the date o f consent acquisition and have no plans to change it while participating in clinical research.
- •4\)Those who do not have a clear wearing\-off phe nomenon.
- •5\)Those who are judged by the doctor that their g eneral condition is stable and that standing / walki ng training can be carried out.
- •6\)Those who can stand up and sit and walk 10 m or more without assistance (regardless of the use of assistive devices).
- •7\)Those who are 20 years old or older at the time of consent
- •8\)Those who have obtained the document conse nt of the subject.
- •9\)Those who meet the following conditions descri bed in the HAL package insert
Exclusion Criteria
- •1\)Those who the doctor judges to be inappropriat e, such as improper standing and walking training 2\)Those who have difficulty wearing HAL due to p hysical deformation, etc.
- •3\)Those who have difficulty in attaching electrode s due to skin diseases, etc.
- •4\)Those who are pregnant
- •5\)Those who have a cognitive function test (MMS
- •E) of 23 points or less.
- •6\)In addition, those who are judged to be inappro priate for conducting this research by the principal investigator or the other investigator.
Outcomes
Primary Outcomes
Not specified
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