Unique ID issued by UMIN | UMIN000031376 |
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Receipt number | R000035828 |
Scientific Title | An open label randomized crossover study on hybrid assistive limb (HAL) therapy for Parkinson disease |
Date of disclosure of the study information | 2018/02/20 |
Last modified on | 2019/02/25 22:13:42 |
An open label randomized crossover study on hybrid assistive limb (HAL) therapy for Parkinson disease
An efficacy study on hybrid assistive limb (HAL) therapy for Parkinson disease
An open label randomized crossover study on hybrid assistive limb (HAL) therapy for Parkinson disease
An efficacy study on hybrid assistive limb (HAL) therapy for Parkinson disease
Japan |
Parkinson disease
Neurology | Rehabilitation medicine |
Others
NO
To validate whether hybrid assistive limb (HAL) therapy is more effective than conventional rehabilitation in improving physical ability of the patients with Parkinson disease.
Efficacy
Exploratory
Pragmatic
Phase II
Primary outcome is walking speed, number of steps, and stride.
Secondary outcomes were Movement Disorder Society-Unified Parkinson Disease Rating Scale
(MDS-UPDRS), postural instability and gait difficulty score of MDS-UPDRS, Time Up and Go test, Mini Balance Evaluation Systems Test, Functional Reach test, Freezing of Gait Questionnaire, Parkinson disease Questionnaire -39.
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Device,equipment |
In the HAL therapy group, the patients undergo walking training with HAL for 40 minutes a day, 9 times in total, and walking training without HAL for 40 minutes a day, 2 times.
In the conventional rehabilitation group, the patients undergo walking training without HAL for 60 minutes, 11 times.
40 | years-old | <= |
85 | years-old | >= |
Male and Female
1. The patients meet clinically established or clinically probable cases of the clinical diagnostic criteria of Parkinson disease by Movement Disorder Society
2. Hoehn & Yahr classification is 3 or 4
3. The patients are treated with L-dopa
4. Hospitalization or outpatient visit is possible during the intervention period
5. Written consent has been obtained
1. Decline in the cognitive function (MMSE 23 points or less)
2. Muscle weakness due to neuromuscular disease
3. The patients cannot walk for 2 minutes
4. Strong posture abnormality (score of '3.13 Posture' in MDS-UPDRS three points or more)
5. Wearing off time of more than 25% of awake time
20
1st name | |
Middle name | |
Last name | Keiji Yamaguchi |
Ichinomiya Nishi Hospital
Neurology
1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, Japan
0586-48-0077
yamaguchikj@hotmail.com
1st name | |
Middle name | |
Last name | Masahiro Kanai |
Ichinomiya Nishi Hospital
Neurology
1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, Japan
0586-48-0077
masabilliard35@yahoo.co.jp
Ichinomiya Nishi Hospital
None
Self funding
NO
2018 | Year | 02 | Month | 20 | Day |
Unpublished
Terminated
2018 | Year | 01 | Month | 15 | Day |
2018 | Year | 02 | Month | 20 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 04 | Month | 30 | Day |
2022 | Year | 05 | Month | 31 | Day |
2022 | Year | 06 | Month | 30 | Day |
2018 | Year | 02 | Month | 19 | Day |
2019 | Year | 02 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035828
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