N/A
N=5
Functional Connectivity & Stimulation-enhanced Therapy Post Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03473808 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Mean Change in Hand Motor Function — 0.83 blocks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- task-practice therapy (Behavioral); Vibration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hand Motor Function |
-14.24 | — |
| PRIMARY Mean Change in Hand Motor Function |
-14.24 | — |
| SECONDARY Mean Change in Hand Motor Function |
-14.24 | — |
| SECONDARY Mean Change in Hand Motor Function |
-14.24 | — |
Summary
After stroke, it is common for individuals to experience hand impairment. This deficit can severely restrict functional ability and independence. Recovery of hand function following stroke is highly variable. In this study, the investigators will use brain imaging to predict individual response to treatment. Survivors of stroke will receive upper extremity therapy while they concurrently receive imperceptible vibration to the wrist aimed to enhance therapy outcomes.
Eligibility Criteria
Inclusion Criteria
- Age = 18 or older
- At least 6 months post-stroke
- Moderate upper limb impairment with the ability to participate in hand task practices
- Fingertip touch sensory deficits (e.g., Monofilament>2.83, 2-point discrimination>5mm, sense of numbness, tingling)
Exclusion Criteria
- Complete upper limb deafferentation
- Rigidity (Modified Ashworth Scale=5)
- Botulinum toxin injection within 3 months prior to enrollment or during enrollment
- Brainstem stroke
- Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
- Concurrent upper extremity rehabilitation therapy
- Language barrier or cognitive impairment that precludes following instructions or providing consent
- MRI incompatible.
Data sourced from ClinicalTrials.gov (NCT03473808). 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.