StrokeTEAACHNCT04245449
E-learning+ Rehab Therapy
A study testing TEAACH in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- TEAACH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Novel Therapy + E-learning Self-management Program for Stroke Survivors
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.
- Conditions
- Stroke
- Being tested
- TEAACH
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAACHBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| e learning+therapy (TEAACH) | Experimental | TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home Receives: Behavioral: TEAACH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Visit and 3 months
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.
Measured: Baseline and 3 months
Secondary outcomes (3)
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.
Measured: Baseline Visit, 3 months and 5 months
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.
Measured: Baseline Visit, 3 months & 5 months
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.
Measured: Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start8 Aug 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: Due to COVID-19 and loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Michelle Woodbury, Medical University of South Carolina
- Investigators
- Michelle Woodbury, PT, PhD, Principal investigator, Medical University of SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245449
- Sponsor's protocol ID
- 00081749
- Other IDs
- P20GM109040-06
- Acronym
- TEAACH
- Status last verified
- Mar 2023
- First submitted
- 21 Jan 2020
- Last updated
- 17 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Therapy + E-learning Self-management Program for Stroke Survivors
- ClinicalTrials.gov ID
- NCT04245449
- Acronym / sponsor ID
- TEAACH / 00081749
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 and loss of funding
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Posted 26 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| e learning+therapy (TEAACH) | Experimental | Behavioral: TEAACHTEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEAACHTEAACH 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. | Behavioural | e learning+therapy (TEAACH) |
Primary outcome
Change in Health Literacy From Baseline to 3 Months
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in Self-Efficacy for Managing Daily Activities From Baseline to 3 Months and 5 Months
Time frame: Baseline Visit, 3 months and 5 months
Change in Social Isolation From Baseline to 3 Months and 5 Months
Time frame: Baseline Visit, 3 months & 5 months
Change in Emotional Support From Baseline to 3 Months and 5 Months
Time frame: Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Woodbury, PT, PhD principal investigator
Medical University of SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAACH in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health Literacy From Baseline to 3 Months (time frame: Baseline Visit and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.