N/A
Completed N=1
Predictors of Response in Chronic Stroke
Stroke · Brain Diseases · Central Nervous System Diseases · nervous system diseases
Source: ClinicalTrials.gov NCT04283253 ↗
Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: A Change in the Fugl-Meyer Upper Extremity Assessment Score — 11; 12; 13; 14 units on a scale
Summary
This study will validate a predictive model that uses demographics, functional status, neurophysiology, neuroanatomy, and other potential biomarkers to predict the likelihood of a clinically significant change in impairment at the end of a robot assisted therapy intervention.The study will include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), and an arm exercise program consisting of robot-assisted exercise combined with functional arm exercise called transition to task training (TTT).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Change in the Fugl-Meyer Upper Extremity Assessment Score |
11; 12; 13; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnosis
- Stroke onset at least 6 months before enrollment
- Present with Mild/Moderate to Severe arm dysfunction (based on Fugl-Meyer scores of 10 to 45)
- Be medically stable to participate in the study
- Be English speaking
Exclusion Criteria
- Unable to give informed consent
- Have a serious complicating medical illness that would preclude participation.
- Contractures or orthopedic problems limiting range of joint motion in the potential study arm
- Visual loss such that the subject would not be able to see the test patterns on the robot computer monitor
- Botulinum toxin to study arm within four months of study enrollment or if received during the study period
- Unable to comply with requirements of the study
- Participants with a history of a seizure will not be precluded from the study, but will not be enrolled in the TMS portions
- Participants with electromagnetic exclusions (metal implants in the cranium, implanted electronic devices etc.) will not be precluded from the study but will be excluded from the MRI and TMS portions
- Have a serious complicating medical illness that would preclude participation
Data sourced from ClinicalTrials.gov (NCT04283253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.