Hybrid Assistive Limb lumber type in SCA

JRCT ID: jRCTs042210162

Registered date:17/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Spinocerebellar ataxia type 3, 6, 31
• Date of first enrollment: 02/02/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): 20 minutes exercise with Hybrid Assistive Limb lumber type once a day, 3 times a week for 4 weeks.

Outcome(s)

• Primary Outcome: Change of the timed up and go test after 4 weeks.

Secondary Outcome

(1)Change of the Timed Up and Go Test after 8 weeks and 16weeks
(2)Change of the Timed Up and Go Test after 8 weeks and 16weeks from 4weeks
(3)Scale for the assessment and rating of ataxia (SARA)
(4)10m timed walking test
(5)Berg Balance Scale (BBS)
(6)Cerebellar cognitive affective syndrome (CCAS) Scale
(7)Visual analogue scale (VAS) for low back pain
(8)Visual analogue scale (VAS) for limb pain
(9)Clinical global impressions (CGI)
(10)Exercise data analysis using a unique data (angle sensor bulit into HAL lumber type, Bio Electrical Signal obtained through electrodes attached to the skin surface, and information on output strength from HAL)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1.Subjects between 20 and 85 years of age at the time of agreement to participate.
2.Subjects genetically diagnosed with SCA3, SCA6 or SCA31.
3.Subjects who fulfill both of the following criteria:
SARA sub score related to gait is between 2 and 6.
In MMSE, total score is higher than 23.
4.Subjects who can make an outpatient visit regularly.
5.Subjects who agree to participate in this study.

Exclude criteria

1.Subjects who cannot put on Hybrid Assistive Limb lumber type.
2.Subjects with symptomatic orthostatic hypotension.
3.Subjects with past histories of dermatitis by patching materials.
4.Subjects with severe heart disease (myocardial infarction, angina, etc).
5.Subjects with past histories of mental disorders (depression etc).
6.Subjects diagnosed with dementia or other neurological disorders at screening.
7.Subjects who are inappropriate to participate in the study.
8.Subjects who participate in other clinical trials.

Related Information

• Primary Sponsor: Katsuno Masahisa
• Source(s) of Monetary Support: CYBERDYNE, INC.,The Hori Sciences and Arts Foundation