A study of the short-term gait improvement effect using a biological signal reaction type motor function improvement device in patients withParkinson's disease.
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-jRCTs052230043
- Lead Sponsor
- Kohara Nobuo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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
a)Weight 40-100kg
b)Those who can wear HAL with a height of about 150 to 190 cm or a body size such as thigh length, lower leg length, and waist width.
10) Those who can about21-day rehabilitation hos
pitalization for PD.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2 minutes walking distance
- Secondary Outcome Measures
Name Time Method 10m walking time <br>Walking speed<br>Walking rate<br> Stride<br>limb muscle strength<br>SPPB <br>ADL FIM<br>UPRDS Part 3 <br>ESAS<br>GSES<br>Posture tilt of body axis <br>Timed Up and Go Test TUG<br>2 minutes walking distanc(7 weeks from date of admission)