Early Phase 1
N=34
Characteristics of Balance Control to Unexpected Loss of Balance During Standing and Walking in Post-stroke Individuals
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02619175 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change in Compensatory Step Execution Time — -119.7; -4.2 msec
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Stroke Subjects Perturbation-Based Balance Training (Device); Stroke Subjects Weight Shifting and Gait training (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Nachum Soroker, MD
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Compensatory Step Execution Time |
-119.7; -4.2 | — |
| PRIMARY Change in Compensatory Step Velocity |
0.05; -0.05 | — |
| SECONDARY Change in Berg Balance Scale Score |
5.7; 5.8 | — |
| SECONDARY Change in Fall Threshold |
1.93; 1.12 | — |
| SECONDARY Change in Activities-specific Balance Confidence (ABC) Scale |
17.9; 4.1 | — |
Summary
aim: To examine the effect of a perturbation-based balance training on balance reaction characteristics in post stroke individuals.
Eligibility Criteria
Inclusion Criteria
For measurements taken while standing, post stroke subjects will meet the criteria of being able to stand independently or with supervision for at least 2 minutes.
For measurements taken while walking, post stroke subjects will meet the criteria of being able to walk for at least 10 meter with supervision/independently without walking aids.
- 3 weeks-6 months post stroke (hemorrhage/infarct)
- First stroke
- Age 25-75 years
- Able to understand research instructions
- Stable clinical/metabolic state
Exclusion Criteria
- - A history of neurological diseases amongst peripheral neuropathy
- Significant skeletal system diseases, such as severe osteoporosis
- Uncontrolled atrial fibrillation
- Unstable ischemic heart disease
- Significant visual deficiency
- Dizziness
- Pregnancy
- Body weight above 135 kg
Data sourced from ClinicalTrials.gov (NCT02619175). 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.