Trial Outcomes & Findings for Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes (NCT NCT04338971)

Last Updated: 2022-01-18

Results Overview

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

"Fugl-Meyer Assessment - Upper Extremity" average change in points from the baseline average score and 12-week average score.

Results posted on

2022-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	IpsiHand Intervention This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the "device") at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System.
Overall Study STARTED	24
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IpsiHand Intervention n=17 Participants This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the "device") at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System. IpsiHand is a device which includes a robotic exoskeleton that you wear on your forearm and hand, an EEG headset worn on your head, and a tablet which includes therapy software and guides you through daily therapy exercises. Once a participant completes an initial EEG screening, the participant completes a set of baseline measurements, the IpsiHand BCI device is then provided to the participants and are to be used a minimum of 5 days a week out of 7 days , for a total duration of 12 weeks. Participants are seen monthly throughout the 12-week duration while they are using the IpsiHand. After completion of device use, participants were asked to be evaluated 6 months after discontinuation of the IpsiHand to assess durability effects.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
Baseline Scores of the "Fugl Meyer Assessment of the Upper Extremity" Score	9.18 score on a scale (range: 0 to 66 points) STANDARD_DEVIATION 5.836 • n=5 Participants

PRIMARY outcome

Timeframe: "Fugl-Meyer Assessment - Upper Extremity" average change in points from the baseline average score and 12-week average score.

Outcome measures

Outcome measures
Measure	IpsiHand Intervention: Change in Fugl-Meyer Assessment of the Upper Extremity n=17 Participants This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the "device") at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System.
Fugl-Meyer Assessment - Upper Extremity	9.18 point change for score on assessment Standard Deviation 5.836

SECONDARY outcome

Timeframe: Change in AMAT score (points) from Baseline to 12 Weeks

The Arm Motor Ability Test (AMAT is used to measure functional limitation in the upper extremity in rehabilitative trials enrolling individuals with stroke primarily. The measure requires clients to perform 28 common unilateral and bilateral UE tasks. Performance on each task is timed by the evaluator and rated by the evaluator using a 6-point Functional Ability Scale from 0 to 5. A score of 0 indicates no attempt moving the affected upper extremity in the task. A score of 5 indicates one is using their affected arm with full movement, normal. One can achieve a total a range of 0 points to 140 points

Outcome measures

Outcome measures
Measure	IpsiHand Intervention: Change in Fugl-Meyer Assessment of the Upper Extremity n=17 Participants This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the "device") at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System.
Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks	12.65 change in points of score on a scale Standard Deviation 4.105

Adverse Events

IpsiHand Intervention

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

Director of Clinical Affairs

Neurolutions

Phone: 831-316-5466

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place