Clinical trial NCT04855032: Post-stroke Perturbation Training
Official title: Proactive and Reactive Perturbation Training to Reduce Falls and Improve Gait Stability in People with Chronic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-04-22
Enrollment: 86
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Following a stroke, many individuals have a high risk of falls, which can negatively influence quality of life. Unfortunately, current treatments have not effectively addressed this problem. This study investigates whether two methods of delivering mechanical perturbations during walking have the potential to improve post-stroke walking balance and reduce real-world fall incidence.


Eligibility criteria: Inclusion Criteria:

* Experience of a stroke at least 6 months prior to participation
* Self-reported experience of a fall in the previous year, and/or a fear of falling
* 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 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

Primary outcomes:
measure: Fall incidence
timeFrame: 32 weeks (12-week period pre-intervention; 12-week period post-intervention)
Secondary outcomes:
measure: Fear of falling
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Functional Gait Assessment
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Activities-specific Balance Confidence scale
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Walking speed
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Foot placement stabilization strategy (mechanics)
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Foot placement stabilization strategy (gluteus medius activity)
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Center of pressure shift stabilization strategy (mechanics)
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Center of pressure shift stabilization strategy (peroneus longus activity)
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Push-off stabilization strategy (mechanics)
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Push-off stabilization strategy (medial gastrocnemius activity)
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Largest rejected perturbation (trained perturbations) Largest rejected perturbation (trunk)
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Largest rejected perturbation (untrained perturbations) Largest rejected perturbation (trunk)
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Angular momentum modulation (trained perturbations) Largest rejected perturbation (trunk)
timeFrame: 8 weeks (pre-intervention; post-intervention)
measure: Angular momentum modulation (untrained perturbations) Largest rejected perturbation (trunk)
timeFrame: 8 weeks (pre-intervention; post-intervention)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jesse Dean
role: PRINCIPAL_INVESTIGATOR
References: