Trial Outcomes & Findings for Treatment of Chronic Stroke With IpsiHand (NCT NCT02552368)

Results Overview

The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia (Lyle, 1981). 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 (Platz, Pinkowski, Kim, di Bella, \& Johnson, 2005). The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3\) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1\) Performs test partially 0) Can perform no part of test The maximum score achievable on this measure is 57 points.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2018-09-17

Participant Flow

Participant milestones

Participant milestones
Measure	IpsiHand IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand. IpsiHand Device: Once a participant has completed (3) EEG Signal Screens and (2) separate set of baseline measurements, the IpsiHand BCI Device is provided to participants to use a minimum of (5) out of (7) days a week for a total duration of 12 weeks. Participants are seen bi-weekly throughout the duration of the trial to assess affected upper extremity and assess functional impact. At the completion of 12 weeks of device use, the participants complete a set of measurements to assess function of the affected upper extremity.
Overall Study STARTED	23
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=10 Participants IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand. IpsiHand Device: Once a participant has completed (3) EEG Signal Screens and (2) separate set of baseline measurements, the IpsiHand BCI Device is provided to participants to use a minimum of (5) out of (7) days a week for a total duration of 12 weeks. Participants are seen bi-weekly throughout the duration of the trial to assess affected upper extremity and assess functional impact. At the completion of 12 weeks of device use, the participants complete a set of measurements to assess function of the affected upper extremity.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=10 Participants
Age, Categorical >=65 years	4 Participants n=10 Participants
Age, Continuous	58.6 years STANDARD_DEVIATION 10.3 • n=10 Participants
Sex: Female, Male Female	1 Participants n=10 Participants
Sex: Female, Male Male	9 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia (Lyle, 1981). 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 (Platz, Pinkowski, Kim, di Bella, \& Johnson, 2005). The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3\) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1\) Performs test partially 0) Can perform no part of test The maximum score achievable on this measure is 57 points.

Outcome measures

Outcome measures
Measure	Change in ARAT From Baseline to 12 Weeks of BCI Device Use n=10 Participants IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.
Change in Action Research Arm Test (ARAT) Score	6.2 units on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: Baseline and 12 weeks

The COPM is an evidence-based outcome measure designed to capture a client's self-perception of performance in 5 patient-identified tasks over time. Patients identified 5 functional activities that they wanted to perform more independently or with greater ease. COPM measurements consisted of a semi-structured interview in which patients rated their performance \& satisfaction with each activity on an ordinal scale from 1 to 10. A performance score of 1 indicated they are unable to perform identified task, \& a score of 10 indicates they are able to complete the functional task as easy as prior to stroke. A satisfaction score of 1 indicated they were not satisfied at all to 10 indicating they are extremely satisfied with how they complete the identified functional task. Patients would rate (5) functional tasks for their performance and satisfaction. Scores were averaged between the scores from the 5 functional activities.

Outcome measures

Outcome measures
Measure	Change in ARAT From Baseline to 12 Weeks of BCI Device Use n=10 Participants IpsiHand is a device which includes a robotic glove that you wear on your hand and a headset that you wear on your head. The headset picks up your thoughts and sends them to the robotic glove, to control opening and closing of your hand.
Canadian Occupational Performance Measure (COPM) Performance	1.56 units on a scale Standard Deviation 1.70
Canadian Occupational Performance Measure (COPM) Satisfaction	1.54 units on a scale Standard Deviation 1.86

Adverse Events

Chronic Stroke Survivors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thy Huskey

Washington University School of Medicine - Department of Neurology

Phone: 314-362-4503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place