Hemiparesis, Stroke
Conditions
Keywords
Constraint-induced movement therapy, gaming, virtual reality, upper extremity, CI therapy, rehabilitation, stroke, hemiparesis, therapy, self-management, in-home, remote, telerehabilitation
Brief summary
The current proposal aims to conduct a multi-site randomized controlled trial comparing virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1) traditional clinic-based CI therapy of equal total active therapy duration and (2) a control group equating the dose of in-person therapy. Individuals with chronic stroke will be randomized to one of four different interventions: (1) traditional clinic-based CI therapy (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI therapy (5 therapist/client contact hours in the clinic and 15 hours of independent game play at home), (3) therapist-as-consultant virtual reality CI therapy with additional therapist contact via telerehabilitation (5 therapist/client contact hours in the clinic, 2.6 therapist contact hours via teleconference, and 15 hours of independent game play in the home), and (4) 5 hours of standard occupational therapy (OT) / physical therapy (PT). After 6-month follow-up, individuals assigned to standard OT/PT will cross over to a modified gaming therapy condition (a stand-alone application of the rehabilitation game without additional therapist contact).
Detailed description
Detailed study description published in BMC Neurology (2017).
Interventions
BEHAVIORALTraditional CI Therapy
Intensive in-person therapy for upper extremity hemiparesis.
BEHAVIORALGaming CI Therapy
Intensive remote (via video game) therapy for upper extremity hemiparesis.
BEHAVIORALGaming 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.
BEHAVIORALTraditional Occupational Therapy/Physical Therapy
Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
Sponsors
OhioHealth
Providence Medical Research Center
University of Alabama at Birmingham
University of Massachusetts, Lowell
University of Missouri-Columbia
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males, females, or any gender identity 18 years of age or older * Experienced a stroke resulting in mild-to-moderate hemiparesis at least six months prior to enrollment (suggested range of motion (ROM) criteria includes: 45° shoulder abduction and flexion, 20° elbow extension, 20° wrist extension, and 10° extension of thumb and finger) * Have preserved ability to comprehend and participate in basic elements of the therapy
Exclusion criteria
* Concurrent participation in other experimental trials for motor dysfunction treatment * Receiving Botox therapy currently or in the past 3 months * Have medical conditions that would place volunteers at higher risk of adverse events (e.g., renal disease, frailty, pregnancy, dementia, severe pain, end-stage/degenerative diseases) * Have received intensive upper-extremity rehabilitation in the chronic phase post-stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Activity Log Quality of Movement Scale | 0 to 1 months | 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. |
| Wolf Motor Function Test | 0 to 1 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bilateral Activity Monitors | 0 to 1 month | 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. |
| Change in Brief Kinesthesia Test (BKT) | 0 to 1 months | This 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. |
| 9 Hole Peg Test | 0 to 1 months | 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. |
| Semmes-Weinstein Monofilament Test | 0 to 1 months | 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. |
| Change in Neuro-Quality of Life (Neuro-QOL) | 0 to 1 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | baseline only measure, exploratory covariate in the analysis | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 44 |
| 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 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. | 45 |
| 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 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. | 38 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 6 Month Follow up | Adverse Event | 1 | 4 | 1 | 3 |
| 6 Month Follow up | Lost to Follow-up | 5 | 8 | 3 | 5 |
| 6 Month Follow up | moved out of state, transportation issues, family medical issue | 0 | 1 | 2 | 1 |
| 6 Month Follow up | Withdrawal by Subject | 1 | 0 | 0 | 2 |
| Treatment Period | Adverse Event | 1 | 0 | 2 | 3 |
| Treatment Period | Family medical issue | 1 | 0 | 0 | 0 |
| 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 |
Baseline characteristics
| Characteristic | Traditional CI Therapy | Gaming CI Therapy | Gaming CI Therapy With Additional Contact Via Video Conference | Traditional Occupational Therapy/Physical Therapy | Total |
|---|---|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 13 | 60 years STANDARD_DEVIATION 14 | 56 years STANDARD_DEVIATION 17 | 63 years STANDARD_DEVIATION 14 | 60 years STANDARD_DEVIATION 15 |
| Montreal Cognitive Assessment (MoCA) | 21.6 units on a scale STANDARD_DEVIATION 6.4 | 22.3 units on a scale STANDARD_DEVIATION 5.4 | 22.5 units on a scale STANDARD_DEVIATION 5.6 | 20.1 units on a scale STANDARD_DEVIATION 6 | 21.7 units on a scale STANDARD_DEVIATION 5.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 14 Participants | 9 Participants | 10 Participants | 42 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) White | 29 Participants | 27 Participants | 30 Participants | 24 Participants | 110 Participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 19 Participants | 8 Participants | 57 Participants |
| Sex: Female, Male Male | 30 Participants | 24 Participants | 26 Participants | 30 Participants | 110 Participants |
| Time since stroke | 4.9 years STANDARD_DEVIATION 9.8 | 5.2 years STANDARD_DEVIATION 6.5 | 3.4 years STANDARD_DEVIATION 5.1 | 5.8 years STANDARD_DEVIATION 8.1 | 4.8 years STANDARD_DEVIATION 7.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 45 | 0 / 44 | 0 / 38 |
| other Total, other adverse events | 0 / 41 | 1 / 45 | 0 / 44 | 0 / 38 |
| serious Total, serious adverse events | 0 / 41 | 0 / 45 | 0 / 44 | 0 / 38 |
Outcome results
Primary
Motor Activity Log Quality of Movement Scale
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.
Time frame: 0 to 1 months
Population: Modified intent-to-treat (those who started treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional CI Therapy | Motor Activity Log Quality of Movement Scale | 1.7 change in mean MAL | Standard Deviation 0.7 |
| Gaming CI Therapy | Motor Activity Log Quality of Movement Scale | 1.3 change in mean MAL | Standard Deviation 0.7 |
| Gaming CI Therapy With Additional Contact Via Video Conference | Motor Activity Log Quality of Movement Scale | 1.5 change in mean MAL | Standard Deviation 0.7 |
| Traditional Occupational Therapy/Physical Therapy | Motor Activity Log Quality of Movement Scale | .5 change in mean MAL | Standard Deviation 0.6 |
Primary
Wolf Motor Function Test
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.
Time frame: 0 to 1 months
Population: Modified intent-to-treat (those who started treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional CI Therapy | Wolf Motor Function Test | -0.38 natural log of performance time change | Standard Deviation 0.35 |
| Gaming CI Therapy | Wolf Motor Function Test | -0.24 natural log of performance time change | Standard Deviation 0.33 |
| Gaming CI Therapy With Additional Contact Via Video Conference | Wolf Motor Function Test | -0.29 natural log of performance time change | Standard Deviation 0.33 |
| Traditional Occupational Therapy/Physical Therapy | Wolf Motor Function Test | -0.22 natural log of performance time change | Standard Deviation 0.36 |
Secondary
9 Hole Peg Test
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.
Time frame: 0 to 1 months
Population: Modified intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional CI Therapy | 9 Hole Peg Test | -.08 change in pegs per minute | Standard Deviation 3.36 |
| Gaming CI Therapy | 9 Hole Peg Test | -.53 change in pegs per minute | Standard Deviation 3.27 |
| Gaming CI Therapy With Additional Contact Via Video Conference | 9 Hole Peg Test | .49 change in pegs per minute | Standard Deviation 2.61 |
| Traditional Occupational Therapy/Physical Therapy | 9 Hole Peg Test | .94 change in pegs per minute | Standard Deviation 4.4 |
Secondary
Bilateral Activity Monitors
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.
Time frame: 0 to 1 month
Population: Those for whom accelerometer data was obtained bilaterally.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional CI Therapy | Bilateral Activity Monitors | .12 change in ratio of arm use | Standard Deviation 0.21 |
| Gaming CI Therapy | Bilateral Activity Monitors | 0 change in ratio of arm use | Standard Deviation 0.25 |
| Gaming CI Therapy With Additional Contact Via Video Conference | Bilateral Activity Monitors | .05 change in ratio of arm use | Standard Deviation 0.2 |
| Traditional Occupational Therapy/Physical Therapy | Bilateral Activity Monitors | .04 change in ratio of arm use | Standard Deviation 0.3 |
Secondary
Change in Brief Kinesthesia Test (BKT)
This 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.
Time frame: 0 to 1 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional CI Therapy | Change in Brief Kinesthesia Test (BKT) | -1.8 sum of vector distances in cm | Standard Deviation 6.6 |
| Gaming CI Therapy | Change in Brief Kinesthesia Test (BKT) | -.9 sum of vector distances in cm | Standard Deviation 4.2 |
| Gaming CI Therapy With Additional Contact Via Video Conference | Change in Brief Kinesthesia Test (BKT) | .8 sum of vector distances in cm | Standard Deviation 4.6 |
| Traditional Occupational Therapy/Physical Therapy | Change in Brief Kinesthesia Test (BKT) | -1.0 sum of vector distances in cm | Standard Deviation 6.3 |
Secondary
Change in Neuro-Quality of Life (Neuro-QOL)
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.
Time frame: 0 to 1 months
Population: Modified intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional CI Therapy | Change in Neuro-Quality of Life (Neuro-QOL) | .69 Mean change in T-score | Standard Deviation 2.13 |
| Gaming CI Therapy | Change in Neuro-Quality of Life (Neuro-QOL) | -.05 Mean change in T-score | Standard Deviation 1.66 |
| Gaming CI Therapy With Additional Contact Via Video Conference | Change in Neuro-Quality of Life (Neuro-QOL) | -.72 Mean change in T-score | Standard Deviation 2.49 |
| Traditional Occupational Therapy/Physical Therapy | Change in Neuro-Quality of Life (Neuro-QOL) | .82 Mean change in T-score | Standard Deviation 2.95 |
Secondary
Semmes-Weinstein Monofilament Test
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.
Time frame: 0 to 1 months
Population: Modified intent-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional CI Therapy | Semmes-Weinstein Monofilament Test | -.25 change in log grams | Standard Deviation 1.11 |
| Gaming CI Therapy | Semmes-Weinstein Monofilament Test | -.39 change in log grams | Standard Deviation 1.66 |
| Gaming CI Therapy With Additional Contact Via Video Conference | Semmes-Weinstein Monofilament Test | -.03 change in log grams | Standard Deviation 1.9 |
| Traditional Occupational Therapy/Physical Therapy | Semmes-Weinstein Monofilament Test | -.50 change in log grams | Standard Deviation 1.93 |
Other Pre-specified
Montreal Cognitive Assessment (MoCA)
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.
Time frame: baseline only measure, exploratory covariate in the analysis
Population: Those who started treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional CI Therapy | Montreal Cognitive Assessment (MoCA) | 21.6 Total score at baseline | Standard Deviation 6.4 |
| Gaming CI Therapy | Montreal Cognitive Assessment (MoCA) | 22.3 Total score at baseline | Standard Deviation 5.4 |
| Gaming CI Therapy With Additional Contact Via Video Conference | Montreal Cognitive Assessment (MoCA) | 22.5 Total score at baseline | Standard Deviation 5.6 |
| Traditional Occupational Therapy/Physical Therapy | Montreal Cognitive Assessment (MoCA) | 20.1 Total score at baseline | Standard Deviation 6 |