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TerminatedNCT04245449TEAACHUpdated Mar 17, 2023Results posted

E-learning+ Rehab Therapy

An interventional study of TEAACH in Stroke, sponsored by Medical University of South Carolina. Terminated at 1 site in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-03-17.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to COVID-19 and loss of funding

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Aug 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
21 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Stroke

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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 7 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    e learning+therapy (TEAACH)

    TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home

    Behavioral: TEAACH

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.

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What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

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Results

Posted Jan 26, 2023

Participant flow

Participant flow — Overall Study
Milestonee Learning+Therapy (TEAACH)
Started7
Completed0
Not completed7
Withdrew: Covid shutdown7

Outcome measures

PrimaryChange 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

No measurements were reported for this outcome.

PrimaryChange 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

No measurements were reported for this outcome.

SecondaryChange 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

No measurements were reported for this outcome.

SecondaryChange 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

No measurements were reported for this outcome.

SecondaryChange 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)

No measurements were reported for this outcome.

Adverse events

Collected over All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
e Learning+Therapy (TEAACH)———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)e Learning+Therapy (TEAACH)
<=18 years0
Between 18 and 65 years7
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)e Learning+Therapy (TEAACH)
Female5
Male2
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)e Learning+Therapy (TEAACH)
Hispanic or Latino0
Not Hispanic or Latino7
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)e Learning+Therapy (TEAACH)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American4
White3
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)e Learning+Therapy (TEAACH)
United States7
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Study locations

1 site
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 14, 2019
  • Informed consent form · Aug 14, 2019

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04245449
Lead sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
Responsible party
Michelle Woodbury (Associate Professor, Medical University of South Carolina) — Principal investigator
First posted
Jan 29, 2020
Start date
Aug 8, 2019
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020
Results posted
Jan 26, 2023
Last update
Mar 17, 2023

Study contacts

Michelle Woodbury, PT, PhD
principal investigator · Medical University of SC

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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