N/A
Completed N=14
Passive Tactile Stimulation for Stroke Rehabilitation
Stroke · Stroke, Ischemic · Stroke Hemorrhagic · Spasticity as Sequela of Stroke
Source: ClinicalTrials.gov NCT03814889 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Change in Modified Ashworth at 12 Weeks — 1.1 units on a scale — p=0.00025
Summary
Stroke can lead to weakness and spasticity in the arm or hand. The purpose of this study is to optimize the design of gentle vibratory stimulation delivered to the hands of individuals with chronic stroke, and explore the effect on range of movement and spasticity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Modified Ashworth at 12 Weeks |
1.1 | 0.00025 sig |
| PRIMARY Change in Modified Ashworth at 8 Weeks |
0.9 | 0.0014 sig |
| PRIMARY Change in Range of Motion at 8 Weeks |
11.6 | 0.02 sig |
| PRIMARY Change in Range of Motion at 12 Weeks |
18.4 | 0.001 sig |
| PRIMARY Change in Modified Ashworth During Stimulation (Pattern 1). |
0.39 | — |
| PRIMARY Change in Modified Ashworth During Stimulation (Pattern 2). |
0.25 | — |
| PRIMARY Change in Modified Ashworth During Stimulation (Pattern 3). |
1.11 | 0.001 sig |
| PRIMARY Change in Modified Ashworth During Stimulation (Sham Control). |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 and older.
- diagnosis of stroke with upper extremity spasticity or other movement deficits that affect strength and range of movement.
- willing to participate in the vibrotactile stimulation sessions for consecutive days and willing to return for follow up visits as needed for the PHASE in progress.
- able to provide informed consent.
Exclusion Criteria
- Patients with severe contracture that precludes Modified Ashworth Score (MAS) testing.
Data sourced from ClinicalTrials.gov (NCT03814889). 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.