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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs052180158
• Date of registration: 25/03/2019
• Prospective Registration: No
• Primary sponsor: Domen Kazuhisa
• Public title: The effect of rehabilitation robots for patients with Parkinson's disease.
• Scientific title: A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient.
• Date of first enrolment: 19/07/2018
• Target sample size: 50
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs052180158
• Study type: Interventional
• Study design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
• Phase: N/A

Contacts

• Name: Kazuhisa Domen
• Affiliation: The hospital of Hyogo College of Medicine

• Name: Koichiro Sota
• Affiliation: The hospital of Hyogo College of Medicine

Key inclusion & exclusion criteria

Inclusion 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)
Exclusion 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

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

Health Condition(s) or Problem(s) studied

Parkinson's Disease

D010300

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.

Primary Outcome(s)

Balance Evaluation Systems Test (BESTest)

Secondary Outcome(s)

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

Secondary ID(s)

UMIN000033454

Source(s) of Monetary Support

TOYOTA Motor Corporation

Ethics review

Status: Approval
Approval date:
Contact:

[e-mail]

The Certified Review Board of Hyogo College of Medicine

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 30/04/2022
• Date Completed: 31/08/2021