Hybrid Assistive Limb lumber type in SCA

Study on efficacy and safety of treatment with Hybrid Assistive Limb lumber type in subjects of spinocerebellar ataxia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042210162

Enrollment

Registered

2022-03-17

Start date

2023-02-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinocerebellar ataxia type 3, 6, 31

Interventions

20 minutes exercise with Hybrid Assistive Limb lumber type once a day, 3 times a week for 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Change of the timed up and go test after 4 weeks.	—

Secondary

Measure	Time frame
(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)	—

Measure

Time frame

(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)

—

Contacts

Public ContactYoshiyuki Kishimoto

Nagoya University Graduate School of Medicine

y.kishimoto116@med.nagoya-u.ac.jp+81-52-744-2390

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026