N/A
Completed N=46
Neurophysiological and Kinematic Predictors of Response in Chronic Stroke
Source: ClinicalTrials.gov NCT02658630 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Stroke Impact Scale: Hand — 20.4; 22.2; 30.0 score on a scale
Summary
The purpose of this study is to design a predictive model of stroke recovery based on baseline measurements of arm movement and brain physiology. The expectation is the development of a formula to predict a person's response to an arm rehabilitation program provided in the chronic phase (6 months or greater post stroke) of recovery. The study will include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), genetic testing using blood and saliva, 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 Stroke Impact Scale: Hand |
20.4; 22.2; 30.0 | — |
| PRIMARY Fugl-Meyer Upper Extremity Assessment |
19.8; 22.2; 24.0; 24.4; 25.2 | — |
| SECONDARY Action Research Arm Test (ARAT) |
14.4; 14.9; 16.2; 16.4; 16.8 | — |
| SECONDARY 6-Item Wolf Motor Function Test (WMFT) |
1.7; 1.8; 1.9; 2.0; 2.0 | — |
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 and not have contractures or other impairments that would interfere with the interventional training.
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
Data sourced from ClinicalTrials.gov (NCT02658630). 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.