Effect of EEG-EMG based hybrid brain-computer interface operated hand exoskeleton for poststroke hand functional recovery

Not Applicable

Completed

• Conditions: Chronic stroke patients suffering from post-stroke hand plegia on either side of the body (left/right); Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN13139098
• Lead Sponsor: KIERI

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30371388 2018 results in https://doi.org/10.1109/JBHI.2018.2863212 (added 20/11/2020) 2018 results in https://doi.org/10.1109/TCDS.2017.2787040 (added 20/11/2020) 2018 results in https://doi.org/10.1109/TOH.2018.2878232 (added 20/11/2020) 2019 results in https://doi.org/10.1109/TNSRE.2019.2908125 (added 20/11/2020) 2019 results in https://doi.org/10.1016/j.jneumeth.2018.11.010 (added 20/11/2020) 2020 results in https://doi.org/10.1109/ACCESS.2020.3026037 (added 20/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-22
• Study Completion: 2020-03-30
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male and female post-stroke volunteers, in the age group of 18-80 years and have normal or corrected to normal vision (e.g. normal vision by using glasses)
2. Six months – two years post-stroke since the first episode of stroke: this is to capture stroke survivors within the chronic stage and also to ensure the stage of fast spontaneous recovery has finished
3. Able to follow two-part spoken or written commands: this is to ensure stroke survivors can provide informed consent and also to ensure they will be able to comply with therapy
4. Have movement disability in at least one of their hands due to stroke
5. Able to get in and out of a low seat unassisted
6. Ready to remove all body piercings

Exclusion Criteria

1. Aged less than 18 years or above 80 years
2. Known to have a progressive neurological condition, any serious medical or psychological diseases which are likely to seriously affect their ability to continue with experimentation
3. Have metal or active implants in their body (excluding dental fillings or crowns)
4. Known to suffer from claustrophobia
5. Pregnant or breastfeeding
6. Gross cognitive impairment or disorientation, evidenced by a score of <21 in the Mini-Mental State Examination (MMSE); the MMSE is an 11-item reliable and valid measure of cognitive function (Folstein, Folstein & McHugh 1975), such that they are unable to follow verbal or written instruction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hand functional recovery measured using action research arm test (ARAT) and the grip-strength (GS) measurement on a weekly basis for a period of 6-8 weeks

Secondary Outcome Measures

Name	Time	Method
Motivation and fatigue measured using the visual analog scale (0-10 cm) before and after each therapy session