Stroke
Conditions
Brief summary
Stroke survivors with arm paresis because of stroke use their good arm for daily activities, but in doing so may be self-limiting their own recovery of the bad arm. Traditional models of stroke rehabilitation fail to fully engage the survivor and care partner(s) in actively planning post-discharge habits that improve their capacity to live well over their entire lives. This study will test a cutting-edge in-person therapy + online training program designed to progressively transfer the responsibility of driving post-stroke recovery from the therapist to the survivor.
Interventions
BEHAVIORALTEAACH
TEAACH e-learning: 3-months of online educational modules include neuroscience education (based on an effective pain educational model37) to improve patient self-efficacy, and strategy-training38 to improve patients' problem-solving abilities for at-home arm use. The course is live on the MUSC MoodleCE platform. TEAACH in-clinic therapy: 24 in-clinic sessions; 3 times/week for 4 weeks (month 1), 2 times/week for 4 weeks (month 2) and 1 time/week for 4 weeks (month 3) with 200 movement repetitions per session. In our RCTs, this therapy dose required \ 1.0-1.5 hours/session. A critical element of TEAACH is the focus on linking in-clinic therapy to out-of-clinic real world paretic arm use via MoodleCE Learning Activities.
Sponsors
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* paresis of one arm/hand because of ischemic or hemorrhagic stroke \>2 mo. and \<3 yrs prior * moderate arm impairment defined as a baseline Fugl-Meyer Assessment of the Upper Extremity score of at least 32±2 points but no more than 47±2 points (out of 60 points) * Montreal Cognitive Assessment score ≥22 * ability to read English * ability to communicate as per the therapists' judgement at baseline testing * 21-90 years of age * wi-fi connection in the home and either a computer, smartphone or tablet.
Exclusion criteria
* lesion or injury to brainstem or cerebellum * other neurological disease that may impair motor or learning skills (e.g., Parkinson's Disease); * pain interfering with reaching * uncorrected vision making it difficult to read information on a computer, tablet or phone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Health Literacy From Baseline to 3 Months | Baseline Visit and 3 months | Health Literacy will be assessed via a standardize 18-item test designed to assess an adult's ability to read and understand common medical terms. Minimum = 0, Maximum = 18. Higher scores indicate greater health literacy. |
| Change in Self Management Skills From Baseline to 3 Months | Baseline and 3 months | Participants' ability to manage their chronic condition (their stroke) will be assessed qualitatively using interview questions. Participants' narratives will be analyzed and reported as a description of how their own skills have changed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Efficacy for Managing Daily Activities From Baseline to 3 Months and 5 Months | Baseline Visit, 3 months and 5 months | Self-Efficacy will be assessed using the NIH PROMIS Self-Efficacy for Managing Daily Activities assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate greater self efficacy. |
| Change in Social Isolation From Baseline to 3 Months and 5 Months | Baseline Visit, 3 months & 5 months | Social Isolation will be assessed using the NIH PROMIS Social Isolation assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate less social isolation. |
| Change in Emotional Support From Baseline to 3 Months and 5 Months | Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days) | Emotional Support will be assessed using the NIH PROMIS Emotional Support assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate greater emotional support. |
Countries
United States
Participant flow
Pre-assignment details
Participants were enrolled however the study is designed so that cohorts start together. Study procedures did not start until a group of subjects were enrolled. Due to Covid shutting the study down study procedures did not start.
Participants by arm
| Arm | Count |
|---|---|
| e Learning+Therapy (TEAACH) TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home
TEAACH: TEAACH e-learning: 3-months of online educational modules include neuroscience education (based on an effective pain educational model37) to improve patient self-efficacy, and strategy-training38 to improve patients' problem-solving abilities for at-home arm use. The course is live on the MUSC MoodleCE platform.
TEAACH in-clinic therapy: 24 in-clinic sessions; 3 times/week for 4 weeks (month 1), 2 times/week for 4 weeks (month 2) and 1 time/week for 4 weeks (month 3) with 200 movement repetitions per session. In our RCTs, this therapy dose required \
1.0-1.5 hours/session. A critical element of TEAACH is the focus on linking in-clinic therapy to out-of-clinic real world paretic arm use via MoodleCE Learning Activities. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | COVID shutdown | 7 |
Baseline characteristics
| Characteristic | e Learning+Therapy (TEAACH) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Change in Health Literacy From Baseline to 3 Months
Health Literacy will be assessed via a standardize 18-item test designed to assess an adult's ability to read and understand common medical terms. Minimum = 0, Maximum = 18. Higher scores indicate greater health literacy.
Time frame: Baseline Visit and 3 months
Population: Although the first subject was enrolled in August 2019, the Project was designed so that a cohort started together. In other words, the study team could not start study procedures until we had a group of subjects enrolled. Hence, although the first participant was enrolled in August, the study team was not able to start the study, because of the covid shut down in March prior to beginning the group related study procedures.
Primary
Change in Self Management Skills From Baseline to 3 Months
Participants' ability to manage their chronic condition (their stroke) will be assessed qualitatively using interview questions. Participants' narratives will be analyzed and reported as a description of how their own skills have changed.
Time frame: Baseline and 3 months
Population: Although the first subject was enrolled in August 2019, the Project was designed so that a cohort started together. In other words, the study team could not start study procedures until we had a group of subjects enrolled. Hence, although the first participant was enrolled in August, the study team was not able to start the study, because of the covid shut down in March prior to beginning the group related study procedures.
Secondary
Change in Emotional Support From Baseline to 3 Months and 5 Months
Emotional Support will be assessed using the NIH PROMIS Emotional Support assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate greater emotional support.
Time frame: Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days)
Population: Although the first subject was enrolled in August 2019, the Project was designed so that a cohort started together. In other words, the study team could not start study procedures until we had a group of subjects enrolled. Hence, although the first participant was enrolled in August, the study team was not able to start the study, because of the covid shut down in March prior to beginning the group related study procedures.
Secondary
Change in Self-Efficacy for Managing Daily Activities From Baseline to 3 Months and 5 Months
Self-Efficacy will be assessed using the NIH PROMIS Self-Efficacy for Managing Daily Activities assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate greater self efficacy.
Time frame: Baseline Visit, 3 months and 5 months
Population: Although the first subject was enrolled in August 2019, the Project was designed so that a cohort started together. In other words, the study team could not start study procedures until we had a group of subjects enrolled. Hence, although the first participant was enrolled in August, the study team was not able to start the study, because of the covid shut down in March prior to beginning the group related study procedures.
Secondary
Change in Social Isolation From Baseline to 3 Months and 5 Months
Social Isolation will be assessed using the NIH PROMIS Social Isolation assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate less social isolation.
Time frame: Baseline Visit, 3 months & 5 months
Population: Although the first subject was enrolled in August 2019, the Project was designed so that a cohort started together. In other words, the study team could not start study procedures until we had a group of subjects enrolled. Hence, although the first participant was enrolled in August, the study team was not able to start the study, because of the covid shut down in March prior to beginning the group related study procedures.