Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502122
• Other study ID #: 201012009IA
• Status: Completed
• Phase: N/A
• Start date: April 24, 2012
• Est. completion date: May 28, 2014

Study information

• Verified date: July 2018
• Source: National Central University, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 28, 2014
• Est. primary completion date: May 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• VR rehabilitation for motor function
rehabilitation for motor function

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Central University, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)	FUGL- MEYER ASSESSMENT OF PHYSICAL PERFORMANCE (FMA)	pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
Secondary	change in upper extremity performance evaluation test for the elderly (TEMPA)	upper extremity performance evaluation test for the elderly (TEMPA)	pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
Secondary	change in Brunnstrom stage	Brunnstrom stage	pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )
Secondary	change in Wolf motor function	Wolf motor function	pre, post (after 24 hrs of intervention) and follow-up (one month after finishing intervention )