Skip to content

Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03502122
Enrollment
48
Registered
2018-04-18
Start date
2012-04-24
Completion date
2014-05-28
Last updated
2018-07-05

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

Conditions

Stroke

Keywords

stroke, rehabilitation

Brief summary

This study aims to design and verify a multi-mode smart assistive device system for Stroke Rehabilitation by using EEG, fMRI, IMU and questioners

Interventions

OTHERVR rehabilitation for motor function

rehabilitation for motor function

Sponsors

National Central University, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* the first time hemiparetic stroke; * diagnosis confirmed by a physician on the basis of the findings of neurological examinations and brain imaging (magnetic resonance imaging or computed tomography scan); * aged between 20 and 85 years; * Brunnstrom's stage II to V over the proximal and distal part of the upper extremity on the affected side; * no cognitive dysfunction, measured by the Mini-Mental State Exam (≧24; suggested by 36 with respect to age and educational level) * willing/able to participate and having signed an informed consent form.

Exclusion criteria

* unstable vital sign * irreversible contracture over any of the joints of the affected upper extremity * history of surgery, fracture, arthritis, pain, or any other complications that might influence the recovery of upper extremity function like aphasia, apraxia and neglect; * having spasticity, as measured using the Modified Ashworth scale (score \> 2); * poststroke seizure; * heart attack within 3 months poststroke; cortical lesions in any of the five core motor areas of interest, including the bilateral M1, the bilateral PM, and the SMA.

Design outcomes

Primary

MeasureTime frameDescription
Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)

Secondary

MeasureTime frameDescription
change in upper extremity performance evaluation test for the elderly (TEMPA)pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )upper extremity performance evaluation test for the elderly (TEMPA)
change in Brunnstrom stagepre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )Brunnstrom stage
change in Wolf motor functionpre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )Wolf motor function

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026