Assistive Soft Robotic Glove Intervention Using Brain-Computer Interface for Elderly Stroke Patients
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|ClinicalTrials.gov Identifier: NCT03277508|
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: BCI Robot Assisted Hand Therapy Device: CPM Robot Assisted Hand Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomization stratification method, with a computer generated random sequence will be used. Subjects will be grouped in strata according to their Fugl-Meyer scores(0-28 vs 29-45) and randomized separately according to a block randomization to receive either of following treatments:(1) Treatment A: 18 sessions for 6 weeks of 60 minutes of passive robot-assisted hand therapy+ 30 minutes of standard hand therapy.(2) Treatment B: 18 sessions for 6 weeks of 60 minutes of BCI controlled robot-assisted hand therapy + 30 minutes of standard hand therapy.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The blinding will be carried out in such a way that the therapist will provide conventional therapy and assess the arm function without knowing the group that the patients belong to. The BCI Robot and Passive Robot will be administered by other study team member. A third party study team member not participating in the intervention will keep the log book which contains information regarding patients study ID and group. Randomization codes will be broken when all interventional and follow-up sessions were completed or when the patient decides to quit participation. The third party team member will unmask according to PI's request in this occasion.|
|Primary Purpose:||Device Feasibility|
|Official Title:||Assistive Soft Robotic Glove Intervention Using Brain-Computer Interface for Elderly Stroke Patients|
|Actual Study Start Date :||March 2, 2018|
|Actual Primary Completion Date :||April 22, 2019|
|Actual Study Completion Date :||April 22, 2019|
Experimental: BCI robot assisted hand therapy
Brain-computer integration robot assisted hand therapy
Device: BCI Robot Assisted Hand Therapy
18 sessions (3 times per week for a total of 6 weeks) of 1.5 hours each training (60 minutes of BCI Robot and 30 minutes of the standard hand therapy).
Session 1-3. Peg game: Lateral movement of gears/cups Session 4-6. Moving cups onto a shelf: Elevation process for the arm, small cups to be used.
Session 7-9. Carrying of basket: Heavier load to be used, patient to hold the basket by the handles at the side, not by its base.
Session 10-12. Opening bottle + pouring into a cup: Training of ADL Session 13-15. Eating: Use of a modified spoon to train ADL Session 16-18. Box and blocks: Precise index finger and thumb control
Active Comparator: CPM robot assisted hand therapy
Continue Passive Movement robot assisted hand therapy
Device: CPM Robot Assisted Hand Therapy
18 sessions (3 times per week for a total of 6 weeks) of 1.5 hours each training (60 minutes of Passive Robot and 30 minutes of the standard hand therapy).The procedure will include the following: Session 1-18: Continuous passive motion
- Action Research Arm Test [ Time Frame: 30 minutes ]It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation
- Fugl-Meyer Assessment [ Time Frame: 20 minutes ]It is designed to assess motor functioning, balance, sensation and joint functioning.
- Grip Strength Test [ Time Frame: 5 minutes ]The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277508
|National University Hospital|
|Singapore, Singapore, 119074|
|Principal Investigator:||Jeong Hoon Lim||National University Hospital, Singapore|