Trial Outcomes & Findings for Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke (NCT NCT03741400)
NCT ID: NCT03741400
Last Updated: 2024-10-09
Results Overview
The change in scores on the Jebsen-Taylor hand function test (JTHFT) from baseline to twelve weeks (in seconds) was compared between treatment groups. The JTHFT is a standardized and objective measure of hand functions commonly used in activities of daily living (ADLs). The test consists of seven subtests separated into fine (JTHFT-Fine) and gross (JTHFT-Gross) motor tasks. Fine motor tasks include writing, simulated page turning, lifting small objects, and simulated feeding. Gross motor tasks include stacking checkers, lifting large light objects, and lifting large heavy objects. The score was calculated as the total number of seconds to perform the tasks, with a lower score indicating better function. Patients who could not complete a task within 90 seconds were assigned a maximum score of 90 seconds for that task. Therefore, the maximum score was 360 sec for the JTHFT-Fine, 270 sec for the JTHFT-Gross, and 630 sec for the JTHFT-Total.
COMPLETED
NA
60 participants
baseline, 12 weeks
2024-10-09
Participant Flow
Participant milestones
| Measure |
Standard Occupational Therapy
Participants in the control arm undergo standard of care occupational therapy as prescribed by their care team.
|
Standard Occupational Therapy + Smart Glove
Participants randomized to this arm use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
24
|
18
|
|
Overall Study
NOT COMPLETED
|
6
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke
Baseline characteristics by cohort
| Measure |
Standard Occupational Therapy
n=24 Participants
Participants in the control arm undergo standard of care occupational therapy as prescribed by their care team.
|
Standard Occupational Therapy + Smart Glove
n=18 Participants
Participants randomized to this arm use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
59 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 12 weeksPopulation: Participants who completed the protocol.
The change in scores on the Jebsen-Taylor hand function test (JTHFT) from baseline to twelve weeks (in seconds) was compared between treatment groups. The JTHFT is a standardized and objective measure of hand functions commonly used in activities of daily living (ADLs). The test consists of seven subtests separated into fine (JTHFT-Fine) and gross (JTHFT-Gross) motor tasks. Fine motor tasks include writing, simulated page turning, lifting small objects, and simulated feeding. Gross motor tasks include stacking checkers, lifting large light objects, and lifting large heavy objects. The score was calculated as the total number of seconds to perform the tasks, with a lower score indicating better function. Patients who could not complete a task within 90 seconds were assigned a maximum score of 90 seconds for that task. Therefore, the maximum score was 360 sec for the JTHFT-Fine, 270 sec for the JTHFT-Gross, and 630 sec for the JTHFT-Total.
Outcome measures
| Measure |
Standard Occupational Therapy
n=24 Participants
Participants in the control arm undergo standard of care occupational therapy as prescribed by their care team.
|
Standard Occupational Therapy + Smart Glove
n=18 Participants
Participants randomized to this arm use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.
|
|---|---|---|
|
Change in Functional Impairment, Jebsen Taylor Hand Function Test
Baseline-Total
|
119 seconds
Interval 92.0 to 176.0
|
181 seconds
Interval 150.0 to 286.0
|
|
Change in Functional Impairment, Jebsen Taylor Hand Function Test
Change at week 12-Total
|
-69 seconds
Interval -129.0 to -20.0
|
-64 seconds
Interval -151.0 to -26.0
|
|
Change in Functional Impairment, Jebsen Taylor Hand Function Test
Baseline-Fine
|
87 seconds
Interval 65.0 to 126.0
|
131 seconds
Interval 97.0 to 185.0
|
|
Change in Functional Impairment, Jebsen Taylor Hand Function Test
Change at week 12-Fine
|
-37 seconds
Interval -99.0 to -8.0
|
-35 seconds
Interval -93.0 to -16.0
|
|
Change in Functional Impairment, Jebsen Taylor Hand Function Test
Baseline-Gross
|
30 seconds
Interval 23.0 to 44.0
|
59 seconds
Interval 50.0 to 84.0
|
|
Change in Functional Impairment, Jebsen Taylor Hand Function Test
Change at week 12-Gross
|
-23 seconds
Interval -92.0 to -5.0
|
-31 seconds
Interval -49.0 to -8.0
|
SECONDARY outcome
Timeframe: baseline, 12 weeksPopulation: Participants who completed the protocol
The change in scores on the Upper Extremity Fugl-Meyer \[0-66, with higher score meaning better motor function\] test from baseline to twelve weeks will be compared between treatment groups. The test measures reflex activity, selective movement, and coordination of the hand, wrist, forearm, elbow, and shoulder.
Outcome measures
| Measure |
Standard Occupational Therapy
n=24 Participants
Participants in the control arm undergo standard of care occupational therapy as prescribed by their care team.
|
Standard Occupational Therapy + Smart Glove
n=18 Participants
Participants randomized to this arm use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.
|
|---|---|---|
|
Change in Functional Impairment, Upper Extremity Fugl-Meyer Assessment
Baseline
|
55 score on a scale
Interval 51.0 to 57.0
|
46 score on a scale
Interval 40.0 to 54.0
|
|
Change in Functional Impairment, Upper Extremity Fugl-Meyer Assessment
Change at week 12
|
8 score on a scale
Interval 2.0 to 13.0
|
8 score on a scale
Interval 5.0 to 17.0
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Participants who completed the protocol.
The change in scores on the Jebsen-Taylor hand function test from baseline to twenty-four weeks (in seconds) was compared between treatment groups. The JTHFT is a standardized and objective measure of hand functions commonly used in activities of daily living (ADLs). The test consists of seven subtests separated into fine (JTHFT-Fine) and gross (JTHFT-Gross) motor tasks. Fine motor tasks include writing, simulated page turning, lifting small objects, and simulated feeding. Gross motor tasks include stacking checkers, lifting large light objects, and lifting large heavy objects. The score was calculated as the total number of seconds to perform the tasks, with a lower score indicating better function. Patients who could not complete a task within 90 seconds were assigned a maximum score of 90 seconds for that task. Therefore, the maximum score was 360 sec for the JTHFT-Fine, 270 sec for the JTHFT-Gross, and 630 sec for the JTHFT-Total.
Outcome measures
| Measure |
Standard Occupational Therapy
n=24 Participants
Participants in the control arm undergo standard of care occupational therapy as prescribed by their care team.
|
Standard Occupational Therapy + Smart Glove
n=18 Participants
Participants randomized to this arm use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.
|
|---|---|---|
|
Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test
Baseline-Total
|
119 seconds
Interval 92.0 to 176.0
|
181 seconds
Interval 150.0 to 286.0
|
|
Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test
Change at week 24-Total
|
-47 seconds
Interval -107.0 to -17.0
|
-82 seconds
Interval -145.0 to -45.0
|
|
Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test
Baseline-Fine
|
87 seconds
Interval 65.0 to 126.0
|
131 seconds
Interval 97.0 to 185.0
|
|
Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test
Change at week 24-Fine
|
-37 seconds
Interval -99.0 to -8.0
|
-35 seconds
Interval -93.0 to -16.0
|
|
Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test
Baseline-Gross Baseline-Gross
|
30 seconds
Interval 23.0 to 44.0
|
59 seconds
Interval 50.0 to 84.0
|
|
Persistence of Treatment Effects at 24 Weeks in Jebsen Taylor Hand Function Test
Change at week 24-Gross
|
-16 seconds
Interval -38.0 to -3.0
|
-33 seconds
Interval -58.0 to -23.0
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Participants who completed the protocol
Change in scores in Upper Extremity Fugl-Meyer \[0-66, with higher score meaning better motor function\] test between baseline and 24 weeks will be compared between treatment groups. The test measures reflex activity, selective movement, and coordination of the hand, wrist, forearm, elbow, and shoulder.
Outcome measures
| Measure |
Standard Occupational Therapy
n=24 Participants
Participants in the control arm undergo standard of care occupational therapy as prescribed by their care team.
|
Standard Occupational Therapy + Smart Glove
n=18 Participants
Participants randomized to this arm use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.
|
|---|---|---|
|
Persistence of Treatment Effects at 24 Weeks in Upper Extremity Fugl-Meyer Test
Baseline
|
55 score on a scale
Interval 51.0 to 57.0
|
46 score on a scale
Interval 40.0 to 54.0
|
|
Persistence of Treatment Effects at 24 Weeks in Upper Extremity Fugl-Meyer Test
Change at week 24
|
7 score on a scale
Interval 0.0 to 13.0
|
11 score on a scale
Interval 6.0 to 19.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who completed the protocol and with available data.
Total dose (minutes) of all upper extremity rehabilitation therapy, including Smart Glove therapy, received during the 12-week intervention period will be compared between treatment groups.
Outcome measures
| Measure |
Standard Occupational Therapy
n=22 Participants
Participants in the control arm undergo standard of care occupational therapy as prescribed by their care team.
|
Standard Occupational Therapy + Smart Glove
n=18 Participants
Participants randomized to this arm use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.
|
|---|---|---|
|
Total Dose of Upper Extremity Rehabilitation
|
584 minutes
Interval 300.0 to 1375.0
|
1434 minutes
Interval 464.0 to 2520.0
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: Participants with available data at the respective time point
Domain scores (0-100, with 100 being better self-rated function in each of: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation) on the Stroke Impact Scale will be compared between treatment groups at 12 weeks and at 24 weeks.
Outcome measures
| Measure |
Standard Occupational Therapy
n=24 Participants
Participants in the control arm undergo standard of care occupational therapy as prescribed by their care team.
|
Standard Occupational Therapy + Smart Glove
n=17 Participants
Participants randomized to this arm use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.
|
|---|---|---|
|
Self-rated Stroke-related Disability Between Each Treatment Group
Week 12
|
63 score on a scale
Interval 38.0 to 88.0
|
65 score on a scale
Interval 40.0 to 85.0
|
|
Self-rated Stroke-related Disability Between Each Treatment Group
Week 24
|
75 score on a scale
Interval 60.0 to 100.0
|
82.5 score on a scale
Interval 60.0 to 85.0
|
Adverse Events
Standard Occupational Therapy
Standard Occupational Therapy + Smart Glove
Serious adverse events
| Measure |
Standard Occupational Therapy
n=30 participants at risk
Participants in the control arm undergo standard of care occupational therapy as prescribed by their care team.
|
Standard Occupational Therapy + Smart Glove
n=30 participants at risk
Participants randomized to this arm use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.
|
|---|---|---|
|
Vascular disorders
Stroke
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
Other adverse events
| Measure |
Standard Occupational Therapy
n=30 participants at risk
Participants in the control arm undergo standard of care occupational therapy as prescribed by their care team.
|
Standard Occupational Therapy + Smart Glove
n=30 participants at risk
Participants randomized to this arm use the Neofect Rapael Smart Glove for a minimum of 20-30 minutes per day, 5 days per week, in addition to prescribed occupational therapy.
|
|---|---|---|
|
Cardiac disorders
atrial fibrilation
|
0.00%
0/30 • 24 weeks
|
6.7%
2/30 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
compression fracture
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Infections and infestations
cystitis
|
3.3%
1/30 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
|
General disorders
dehydration
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Gastrointestinal disorders
diarrhea
|
3.3%
1/30 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
|
Nervous system disorders
dizziness
|
3.3%
1/30 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
General disorders
ennui
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Eye disorders
eyelid injury
|
3.3%
1/30 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
|
Injury, poisoning and procedural complications
fall
|
3.3%
1/30 • 24 weeks
|
6.7%
2/30 • 24 weeks
|
|
Infections and infestations
fever
|
3.3%
1/30 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
|
Nervous system disorders
headache
|
3.3%
1/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Cardiac disorders
hypertension
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Metabolism and nutrition disorders
hypokalemia
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Cardiac disorders
hypotension
|
3.3%
1/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
inversion trauma ankle
|
3.3%
1/30 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
|
Nervous system disorders
loss of balance
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
multiple myeloma
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
General disorders
pain
|
3.3%
1/30 • 24 weeks
|
6.7%
2/30 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
phalanx fracture
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Infections and infestations
pneumonia
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
reduced strength
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
sleep apnea
|
3.3%
1/30 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
|
Cardiac disorders
syncope
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
upper extremity stiffness
|
3.3%
1/30 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
Renal and urinary disorders
urinary tract infection
|
0.00%
0/30 • 24 weeks
|
3.3%
1/30 • 24 weeks
|
|
General disorders
weight loss
|
3.3%
1/30 • 24 weeks
|
0.00%
0/30 • 24 weeks
|
Additional Information
Maarten G. Lansberg, MD PhD
Professor of Neurology and Neurological Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER