The effect of rehabilitation robots for patients with Parkinson's disease.

JRCT ID: jRCTs052180158

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's Disease
• Date of first enrollment: 19/07/2018
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Robot group: The participants performs twelve per a session, 2sessions per a week for 8 weeks.
Control group: The participants receives balance exercise by physical therapist twice a week for 8 weeks.

Outcome(s)

• Primary Outcome: Balance Evaluation Systems Test (BESTest)

Secondary Outcome

10m walking time and steps
Timed Up and Go test
Tandem gait speed
Continuous tandem gait steps
Functional Reach Test
Functional Balance Scale
mini-Balance Evaluation Systems Test
Unified Parkinson's Disease Rating Scale
Parkinson's Disease Questionnaire-39
Neuropsychological examination
Movie shooting (frontal plane, sagittal plane)
Evaluation of safety

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Clinical diagnosis of Parkinson's disease
40-80 years old
Hohen-Yahr severity classification I to III
BESTest total score is less than 75%
MMSE has 24 points or more
Parkinson's disease drug is stable (No change in the past 3 months)

Exclude criteria

Mergers of neurological diseases other than Parkinson's disease
Robot training including BEAR within the past 6 months
Those who recognize severe aphasia (those with FIM understanding less than or equal to 2)
Those who recognize severe higher brain dysfunction (those with two or less of FIM social exchanges, memory, problem solving)
Person who may exercise load may lead to deterioration of physical condition.
High blood pressure with poor control (systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more)
Heart rate at resting 100 / minute or more
Limitation of motion due to cardiac function, respiratory dysfunction
Lower extremity circulatory disorder with ulcer in the lower extremity and diabetic peripheral neuropathy
Severe joint contracture and deformity
Other restrictions on motion for some reason
Persons who have a possibility of hindering practice practice that physical conditions are safe
To some extent visually impaired obstacles to training, hearing disorder
Possibility of incontinence to soil the robot

Related Information

• Primary Sponsor: Domen Kazuhisa
• Source(s) of Monetary Support: TOYOTA Motor Corporation
• Secondary ID(s): UMIN000033454