Trial Outcomes & Findings for Effectiveness of Virtual Reality Gaming Therapy Versus CI Therapy for Upper Extremity Rehabilitation (NCT NCT02631850)
NCT ID: NCT02631850
Last Updated: 2021-10-05
Results Overview
Assesses the time to complete 15 standardized tasks (e.g., folding a towel, stacking checkers, placing hand on top of a box). Items that cannot be accomplished score 120 seconds. Times are natural log transformed to reflect proportional improvement (approximate % change) and correct for skew. On the log transformed scale, -.22 reflects normal ability, 4.79 = can't accomplish task. For improvement in mean log transformed performance time, -4.79 = best possible improvement, 0 = no improvement, positive scores = worsening. A proportional improvement of 16% (mean log transformed performance time change = -.17) is considered clinically meaningful.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
193 participants
Primary outcome timeframe
0 to 1 months
Results posted on
2021-10-05
Participant Flow
193 participants met enrollment criteria and signed a consent form during the screening visit. 14 withdrew shortly thereafter, citing logistical challenges (e.g., scheduling, transportation). 5 no-showed to the first treatment session and could not be reached. 4 experienced medical events that prompted them to withdraw prior to beginning treatment. 2 could not be contacted to schedule participation. The randomization assignment was recycled back into pool for those who did not begin treatment.
Participant milestones
| Measure |
Traditional CI Therapy
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
|---|---|---|---|---|
|
Treatment Period
STARTED
|
41
|
44
|
45
|
38
|
|
Treatment Period
COMPLETED
|
38
|
38
|
41
|
33
|
|
Treatment Period
NOT COMPLETED
|
3
|
6
|
4
|
5
|
|
6 Month Follow up
STARTED
|
38
|
38
|
41
|
33
|
|
6 Month Follow up
COMPLETED
|
31
|
25
|
35
|
22
|
|
6 Month Follow up
NOT COMPLETED
|
7
|
13
|
6
|
11
|
Reasons for withdrawal
| Measure |
Traditional CI Therapy
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
|---|---|---|---|---|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Treatment Period
Protocol Violation
|
1
|
0
|
0
|
0
|
|
Treatment Period
Withdrawal by Subject
|
0
|
5
|
2
|
2
|
|
Treatment Period
Adverse Event
|
1
|
0
|
2
|
3
|
|
Treatment Period
Family medical issue
|
1
|
0
|
0
|
0
|
|
6 Month Follow up
Lost to Follow-up
|
5
|
8
|
3
|
5
|
|
6 Month Follow up
Withdrawal by Subject
|
1
|
0
|
0
|
2
|
|
6 Month Follow up
Adverse Event
|
1
|
4
|
1
|
3
|
|
6 Month Follow up
moved out of state, transportation issues, family medical issue
|
0
|
1
|
2
|
1
|
Baseline Characteristics
Effectiveness of Virtual Reality Gaming Therapy Versus CI Therapy for Upper Extremity Rehabilitation
Baseline characteristics by cohort
| Measure |
Traditional CI Therapy
n=40 Participants
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
n=44 Participants
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
n=45 Participants
This group will receive treatment that is identical to Group 2, but will receive an additional 4 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
n=38 Participants
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of stretching exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 13 • n=5 Participants
|
60 years
STANDARD_DEVIATION 14 • n=7 Participants
|
56 years
STANDARD_DEVIATION 17 • n=5 Participants
|
63 years
STANDARD_DEVIATION 14 • n=4 Participants
|
60 years
STANDARD_DEVIATION 15 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Time since stroke
|
4.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
5.2 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
3.4 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
5.8 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
4.8 years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Montreal Cognitive Assessment (MoCA)
|
21.6 units on a scale
STANDARD_DEVIATION 6.4 • n=5 Participants
|
22.3 units on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
22.5 units on a scale
STANDARD_DEVIATION 5.6 • n=5 Participants
|
20.1 units on a scale
STANDARD_DEVIATION 6.0 • n=4 Participants
|
21.7 units on a scale
STANDARD_DEVIATION 5.9 • n=21 Participants
|
PRIMARY outcome
Timeframe: 0 to 1 monthsPopulation: Modified intent-to-treat (those who started treatment)
Assesses the time to complete 15 standardized tasks (e.g., folding a towel, stacking checkers, placing hand on top of a box). Items that cannot be accomplished score 120 seconds. Times are natural log transformed to reflect proportional improvement (approximate % change) and correct for skew. On the log transformed scale, -.22 reflects normal ability, 4.79 = can't accomplish task. For improvement in mean log transformed performance time, -4.79 = best possible improvement, 0 = no improvement, positive scores = worsening. A proportional improvement of 16% (mean log transformed performance time change = -.17) is considered clinically meaningful.
Outcome measures
| Measure |
Traditional CI Therapy
n=41 Participants
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
n=44 Participants
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
n=45 Participants
This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
n=38 Participants
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
|---|---|---|---|---|
|
Wolf Motor Function Test
|
-0.38 natural log of performance time change
Standard Deviation 0.35
|
-0.24 natural log of performance time change
Standard Deviation 0.33
|
-0.29 natural log of performance time change
Standard Deviation 0.33
|
-0.22 natural log of performance time change
Standard Deviation 0.36
|
PRIMARY outcome
Timeframe: 0 to 1 monthsPopulation: Modified intent-to-treat (those who started treatment)
Assessment evaluates the amount and quality of everyday arm use. The scale consists of 28 activities of daily living (e.g., washing hands, drinking from a cup). Participants self-report on an 11-point scale (0-5 with half-point increments, 0=not attempted to 5=attempted with normal movement). The total score on the measure reflects the mean of the individual item scores. A change of 1.0 on the scale is considered clinically meaningful.
Outcome measures
| Measure |
Traditional CI Therapy
n=40 Participants
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
n=44 Participants
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
n=45 Participants
This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
n=38 Participants
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
|---|---|---|---|---|
|
Motor Activity Log Quality of Movement Scale
|
1.7 change in mean MAL
Standard Deviation .7
|
1.3 change in mean MAL
Standard Deviation .7
|
1.5 change in mean MAL
Standard Deviation .7
|
.5 change in mean MAL
Standard Deviation .6
|
SECONDARY outcome
Timeframe: 0 to 1 monthsPopulation: Modified intent-to-treat
Computerized adaptive assessment on several domains of quality of life: sleep, mobility, positive affect and well-being, fatigue, satisfaction with social roles, cognitive function, anxiety, and communication. Neuro-QOL uses a T score which has a mean of 50 and SD of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a higher score reflects more of what is being measured. Scores are reported as mean T-scores across the assessed domains. Positive changes indicate an improvement.
Outcome measures
| Measure |
Traditional CI Therapy
n=40 Participants
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
n=44 Participants
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
n=45 Participants
This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
n=38 Participants
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
|---|---|---|---|---|
|
Change in Neuro-Quality of Life (Neuro-QOL)
|
.69 Mean change in T-score
Standard Deviation 2.13
|
-.05 Mean change in T-score
Standard Deviation 1.66
|
-.72 Mean change in T-score
Standard Deviation 2.49
|
.82 Mean change in T-score
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: 0 to 1 monthPopulation: Those for whom accelerometer data was obtained bilaterally.
Devices to monitor upper extremity movement are worn throughout treatment. The devices count movements made with each arm, defined as an acceleration of 2g for at least 500 ms. The ratio of more affected to less affected arm use is then calculated for each treatment day. The best linear fit trajectory for each participant is calculated after removal of outliers. The treatment change reported here reflects the difference between the best-fit-line at post-treatment and the best-fit-line at pre-treatment. Positive change indicates improvement.
Outcome measures
| Measure |
Traditional CI Therapy
n=15 Participants
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
n=21 Participants
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
n=22 Participants
This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
n=19 Participants
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
|---|---|---|---|---|
|
Bilateral Activity Monitors
|
.12 change in ratio of arm use
Standard Deviation .21
|
0 change in ratio of arm use
Standard Deviation .25
|
.05 change in ratio of arm use
Standard Deviation .20
|
.04 change in ratio of arm use
Standard Deviation .30
|
SECONDARY outcome
Timeframe: 0 to 1 monthsThis measures was intended to measure proprioception in the upper extremity; however, performance on the measure is also known to be adversely affected by motor impairment. The experimenter guides individuals along movement trajectories between 2 and 9 inches with their vision obscured. They are then asked to reproduce the movement trajectories. The summed difference between the desired and produced trajectory endpoints in cm is reported. A negative change indicates an improvement.
Outcome measures
| Measure |
Traditional CI Therapy
n=40 Participants
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
n=44 Participants
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
n=45 Participants
This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
n=38 Participants
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
|---|---|---|---|---|
|
Change in Brief Kinesthesia Test (BKT)
|
-1.8 sum of vector distances in cm
Standard Deviation 6.6
|
-.9 sum of vector distances in cm
Standard Deviation 4.2
|
.8 sum of vector distances in cm
Standard Deviation 4.6
|
-1.0 sum of vector distances in cm
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 0 to 1 monthsPopulation: Modified intent-to-treat
Sensory evaluator of touch sensation. Units are the log transformed grams of pressure detected by the index finger of the paretic hand. Scores range from -1.8 to 5.7. Smaller scores indicate better sensation. Negative change indicates improvement.
Outcome measures
| Measure |
Traditional CI Therapy
n=40 Participants
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
n=44 Participants
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
n=45 Participants
This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
n=38 Participants
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
|---|---|---|---|---|
|
Semmes-Weinstein Monofilament Test
|
-.25 change in log grams
Standard Deviation 1.11
|
-.39 change in log grams
Standard Deviation 1.66
|
-.03 change in log grams
Standard Deviation 1.90
|
-.50 change in log grams
Standard Deviation 1.93
|
SECONDARY outcome
Timeframe: 0 to 1 monthsPopulation: Modified intent-to-treat
Assessment to measure upper extremity distal motor function. The assessment measures the time to place 9 pegs into grooves on a board. Due to the inability of a majority of the participants to place all 9 pegs during the 120 seconds allotted for the test, performance was transformed into a rate metric to reduce floor effects. The outcome is expressed as change in the number of pegs per minute.
Outcome measures
| Measure |
Traditional CI Therapy
n=40 Participants
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
n=44 Participants
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
n=45 Participants
This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
n=38 Participants
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
|---|---|---|---|---|
|
9 Hole Peg Test
|
-.08 change in pegs per minute
Standard Deviation 3.36
|
-.53 change in pegs per minute
Standard Deviation 3.27
|
.49 change in pegs per minute
Standard Deviation 2.61
|
.94 change in pegs per minute
Standard Deviation 4.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline only measure, exploratory covariate in the analysisPopulation: Those who started treatment
Assessment to measure cognitive function at baseline. The range of the MoCA assessment is 0-30. Scores below 24 indicate cognitive impairment and scores below 16 indicate severe cognitive impairment. The MoCA was administered for the purpose of characterizing the study population and was examined as a potential covariate in linear mixed effect models examining primary and secondary outcome measures.
Outcome measures
| Measure |
Traditional CI Therapy
n=40 Participants
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
n=44 Participants
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
n=45 Participants
This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
n=38 Participants
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
|---|---|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
|
21.6 Total score at baseline
Standard Deviation 6.4
|
22.3 Total score at baseline
Standard Deviation 5.4
|
22.5 Total score at baseline
Standard Deviation 5.6
|
20.1 Total score at baseline
Standard Deviation 6.0
|
Adverse Events
Traditional CI Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gaming CI Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Gaming CI Therapy With Additional Contact Via Video Conference
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Traditional Occupational Therapy/Physical Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Traditional CI Therapy
n=41 participants at risk
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
Traditional CI Therapy: Intensive in-person therapy for upper extremity hemiparesis.
|
Gaming CI Therapy
n=45 participants at risk
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
Gaming CI Therapy: Intensive remote (via video game) therapy for upper extremity hemiparesis.
|
Gaming CI Therapy With Additional Contact Via Video Conference
n=44 participants at risk
This group will receive treatment that is identical to Group 2, but will receive an additional 4 hours video conference consultation throughout the treatment period.
Gaming CI Therapy with Additional Contact via Video Conference: Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
|
Traditional Occupational Therapy/Physical Therapy
n=38 participants at risk
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of stretching exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
Traditional Occupational Therapy/Physical Therapy: Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
bruising on wrist from wearing monitoring watch too tight
|
0.00%
0/41 • 7 months
|
2.2%
1/45 • Number of events 1 • 7 months
|
0.00%
0/44 • 7 months
|
0.00%
0/38 • 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place