N/A
N=58
Predicting Ipsilesional Motor Deficits in Stroke With Dynamic Dominance Model
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03634397 ↗Enrolled (actual)
58
Serious AEs
5.2%
Results posted
Apr 2025
Primary outcome: Primary: Change in Jebsen-Taylor Hand Function Test (JTHFT) Times From Baseline 2 to Post Test 1 — 5.07; -.11 seconds — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Less-Impaired Arm Training (Behavioral); Contralesional Arm Comparison (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Robert L. Sainburg
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Jebsen-Taylor Hand Function Test (JTHFT) Times From Baseline 2 to Post Test 1 |
5.07; -.11 | <.05 sig |
| PRIMARY Change in Abilhand Scores From Baseline 2 (Prior to Treatment) to Post Test 1 |
-2.08; -.57 | — |
| PRIMARY Change of Score on Barthel Index From Baseline 2 (Prior to Training) to Post Test 1 |
-1.2; -1.79 | <.05 sig |
| PRIMARY Change in Upper-Extremity Fugl-Meyer Assessment (FM) Score From Baseline 2 (Prior to Training) to Post Test 1 |
-.68; -1.61 | <.05 sig |
| SECONDARY Change From Baseline 2 (Prior to Training) to Post Test 1on Functional Independence Measure (FIM) -Self Care Components |
-1.44; -.46 | — |
| SECONDARY Change From Baseline 2 (Prior to Training) to Post Test 1 on Contralesional Work Space Area (Kinematics) |
0.512; 0.340 | — |
| SECONDARY Change in Kinematics- Positional Variability at Maximum Velocity From Baseline 2 (Prior to Training) to Post Test 1 |
0.0930727; -0.0225708; 0.2811583; -0.1156399 | — |
Summary
This study will test the hypothesis that the combination of low-moderate to severe motor deficits in the paretic arm and persistent motor deficits in the less-impaired arm limits functional independence in chronic stroke survivors. We, therefore, predict that intense remediation, focused on improving the speed, coordination, and accuracy of the less-impaired arm should improve functional independence.
Eligibility Criteria
Inclusion Criteria
- neuroradiological confirmation of unilateral brain damage with residual contralesional upper-extremity weakness
- deficits in ipsilesional arm performance assessed by the JTHFT
- 6+ months post stroke
- Demonstrates cognitive abilities
Exclusion Criteria
a history of:
- neurological disease other than stroke (e.g., head trauma)
- a major psychiatric diagnosis (e.g., schizophrenia, major affective disorder),
- hospital admission for substance abuse
- peripheral disorders affecting sensation or movement of the upper extremities, including pain or arthritis
- currently taking prescription drugs with known sedative properties that are interfering with sensory-motor function
- significant joint pain that is activity limiting
- bilateral stroke
Data sourced from ClinicalTrials.gov (NCT03634397). 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.