JRCT ID: jRCTs042180060
Registered date:01/03/2019
A Study on Training Effect by Robot Suit HAL for Medical Use (Lower Limb Type) - Verification in patients with Parkinson's disease -
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Parkinson's disease |
Date of first enrollment | 08/03/2019 |
Target sample size | 30 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | The training consist of two periods. In the HAL period, the patient performs 2 sets of rehabilitation of 5 days training with HAL for 60 minutes followed by 2 days conventional training for 40 minutes. In the conventional period, the patient performs 2 sets of conventional rehabilitation sessions of 5 days training for 60 minutes followed by 2 days training for 40 minutes. The HAL group takes at first the HAL period followed by the conventional period. The conventional group takes at first the conventional period followed by the HAL period. |
Outcome(s)
Primary Outcome | Timed up and Go test |
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Secondary Outcome | age, gender, height, weight, disease duration, HDS-R, Hoehn & Yahr staging scale, Classification according to clinical diagnostic criteria of Parkinson's disease by MDS, MDS-UPDRS part III, freezing of gait questionnaire(FOG-Q), 10m gait speed, step length, Berg Balance Scale(BBS), Video |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | -Patients diagnosed as clinically established or clinically probable Parkinson's disease with Movement Disorder Society (MDS) clinical diagnostic criteria -Patients who meet the stage 2-4 for Hoehn & Yahr staging scale -Patients who consent with full understanding -Patients judged that who are stable, and able to stand and walk -Patients with the ability to stand and walk more than 10 m without assistance -Patients' weight: 40 to 100 kg -Patients' heights: 150 to 190 cm |
Exclude criteria | -Patients planned to change the dose of anti-Parkinson's disease drug -Patients judged as inappropriate for the walking training -Patients have difficulties with wearing HAL -Patients have difficulties with putting the electrodes on the skin -Patients during pregnancy -Patients have difficulties with understanding instructions |
Related Information
Primary Sponsor | Ogawa Tetsuo |
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Secondary Sponsor | Tajima Yoriko |
Source(s) of Monetary Support | Nagoya City Rehabilitation Agency |
Secondary ID(s) | UMIN000031551 |
Contact
Public contact | |
Name | Yutaka Kondou |
Address | 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Aichi Aichi Japan 467-8622 |
Telephone | +81-52-835-3811 |
physical@nagoya-rehab.or.jp | |
Affiliation | Nagoya City Rehabilitation Center |
Scientific contact | |
Name | Tetsuo Ogawa |
Address | 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Aichi Aichi Japan 467-8622 |
Telephone | +81-52-835-3811 |
tets@tcp-ip.or.jp | |
Affiliation | Nagoya City Rehabilitation Center |