Early Phase 1
N=44
Sensory Augmentation Methods in Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03988400 ↗Enrolled (actual)
44
Serious AEs
2.3%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Participants With Related or Serious Adverse Events — 1; 0 Participants — p=1
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Sensory Augmentation (Behavioral); Random Vibration (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Related or Serious Adverse Events |
1; 0 | 1 |
| PRIMARY Number of Training Sessions Attended |
7; 8 | 0.017 sig |
| PRIMARY Intervention Feasibility (Drop-out) |
2; 1 | 1 |
| PRIMARY Change in Mechanics-dependent Adjustment of Paretic Foot Placement |
0.078; 0.054 | 0.72 |
| SECONDARY Intervention Feasibility (Walking Time) |
144; 255 | 0.001 sig |
| SECONDARY Change in Fear of Falling |
8; 10; 8; 9 | 0.68 |
| SECONDARY Change in Functional Gait Assessment Score |
0.8; 1.7 | 0.25 |
| SECONDARY Change in Activity-specific Balance Confidence Score |
1.0; 2.1 | 0.69 |
| SECONDARY Change in Overground Self-selected Gait Speed |
0.01; 0.05 | 0.20 |
Summary
Many chronic stroke survivors have poor walking balance, contributing to an increased risk of falls and fear of falling. One factor contributing to these balance deficits is a reduced ability to place the feet appropriately when walking. This study investigates whether enhancing the sensory information available to chronic stroke survivors while they walk improves their foot placement accuracy and balance.
Eligibility Criteria
Inclusion Criteria
- Experience of a stroke 6 months prior to participation
- Gait speed of at least 0.2 m/s
- Ability to walk on a treadmill without a cane or walker
- Provision of informed consent
Exclusion Criteria
- Evidence of cerebellar damage
- Resting blood pressure higher than 220/110 mm Hg
- History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- Preexisting neurological disorders or dementia
- Legal blindness or severe visual impairment
- History of DVT or pulmonary embolism within 6 months
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
- Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern
Data sourced from ClinicalTrials.gov (NCT03988400). 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.