Trial Outcomes & Findings for Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke (NCT NCT03559829)

NCT ID: NCT03559829

Last Updated: 2019-05-01

Results Overview

Number of days during 8 week study-period that patient used the device.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2019-05-01

Participant Flow

Participant milestones

Measure	Single Arm - Intervention Arm RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke

Baseline characteristics by cohort

Measure	Single Arm - Intervention Arm n=20 Participants RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Age, Continuous	52 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	9 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	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Jebsen Hand Function Test Overall Score	379 seconds STANDARD_DEVIATION 203 • n=5 Participants
Jebsen Hand Function Test Fine-Motor Score	239 seconds STANDARD_DEVIATION 104 • n=5 Participants
Jebsen Hand Function Test Gross-Motor Score	141 seconds STANDARD_DEVIATION 104 • n=5 Participants
Fugl-Meyer Assessment	41 score on a scale STANDARD_DEVIATION 11 • n=5 Participants
Manual Muscle Testing (MMT) Score	9.6 score on a scale STANDARD_DEVIATION 3.3 • n=5 Participants
Stroke Impact Scale (SIS)	65 score on a scale STANDARD_DEVIATION 12 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Number of days during 8 week study-period that patient used the device.

Outcome measures

Measure	Single Arm - Intervention Arm n=20 Participants RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Device Use	27 days Standard Deviation 34

SECONDARY outcome

Timeframe: 8 weeks

Daily average number of minutes of device-use per days that device was used.

Outcome measures

Measure	Single Arm - Intervention Arm n=20 Participants RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Device Use Daily Average Per Use Day	27 minutes Standard Deviation 16

SECONDARY outcome

Timeframe: 8 weeks

Daily average number of minutes of device-use during 8-week intervention period.

Outcome measures

Measure	Single Arm - Intervention Arm n=20 Participants RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Device Use Daily Average	16.0 minutes Standard Deviation 15.4

SECONDARY outcome

Timeframe: 8 weeks

Time (in seconds) to complete the total Jebsen-Taylor Hand Function Test administered at 8-weeks. The test consists of 7 subtests. Each subtest is allotted a maximum time of 90 seconds. The total score is the sum of the scores of the seven subtests. The total score has a maximum of 630 seconds and there is no minimum. Longer time to complete the test indicates worse hand function.

Outcome measures

Measure	Single Arm - Intervention Arm n=20 Participants RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Jebsen-Taylor Hand Function Test - Overall Score	353 seconds Standard Deviation 208

SECONDARY outcome

Timeframe: 8 weeks

Time (in seconds) to complete the four fine-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks. Each of the four subtests is allotted a maximum time of 90 seconds. The total score is the sum of the scores of the four subtests. The total score has a maximum of 360 seconds and there is no minimum. Longer time to complete the test indicates worse hand function.

Outcome measures

Measure	Single Arm - Intervention Arm n=20 Participants RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Jebsen-Taylor Hand Function Test - Fine Score	217 seconds Standard Deviation 105

SECONDARY outcome

Timeframe: 8 weeks

Time (in seconds) to complete the three gross-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks. Each of the three gross-motor subtests is allotted a maximum time of 90 seconds. The total gross-motor score is the sum of the scores of the three subtests. The total score has a maximum of 270 seconds and there is no minimum. Longer time to complete the test indicates worse hand function.

Outcome measures

Measure	Single Arm - Intervention Arm n=20 Participants RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Jebsen-Taylor Hand Function Test - Gross Score	135 seconds Standard Deviation 108

SECONDARY outcome

Timeframe: 8 weeks

Upper Extremity Fugl-Meyer Test score at 8-weeks. Score ranges from 0 to 66, with higher scores corresponding to better arm function.

Outcome measures

Measure	Single Arm - Intervention Arm n=20 Participants RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Fugl-Meyer Assessment	43 score on a scale Standard Deviation 12

SECONDARY outcome

Timeframe: 8 weeks

The MMT score is the sum of the Medical Research Council (MRC) scores across 5 domains (elbow flexor, elbow extensor, wrist extension, finger extension and finger flexion) at 8 weeks. Each domain has a scale range of 0 to 5, with higher scores corresponding to better strength. Maximum MMT score ranges from 0-25, with higher scores corresponding to better strength.

Outcome measures

Measure	Single Arm - Intervention Arm n=20 Participants RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Manual Muscle Testing (MMT) Score	10.0 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: 8 weeks

Score on the SIS at 8-weeks. The score ranges from 0 to 100, with higher scores corresponding to better recovery from stroke.

Outcome measures

Measure	Single Arm - Intervention Arm n=20 Participants RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Stroke Impact Scale (SIS)	71 score on a scale Standard Deviation 11

SECONDARY outcome

Timeframe: 8 weeks

Patient self-reported satisfaction with device use (5-point Likert Scale, with higher scores indicating greater satisfaction).

Outcome measures

Measure	Single Arm - Intervention Arm n=20 Participants RAPAEL Smart Glove Arm used for 8 weeks (60 min per day for at least 5 days per week)
Patient Experience	4.38 score on a scale Standard Deviation 0.50

Adverse Events

Single Arm - Intervention Arm

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

Maarten G. Lansberg, MD PhD

Associate Professor of Neurology and Neurological Sciences

Phone: (650) 723-4448

Email: lansberg@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place