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NCT05723822
Effects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments
Conditions: Mild Cognitive Impairment, Cognitive Decline, Gait Disorders in Old Age
Sex: All
Ages: 65 Years – N/A
Phase: NA
Enrollment: 20
Sponsor: RxFunction Inc.
Location: United States
Summary
The primary aim of this pilot study is to investigate the effect of Walkasins, a wearable lower-limb sensory prosthesis, on the gait speed and balance function of participants with mild cognitive impairment as measured by the Saint Louis University Mental Status (SLUMS) Examination.
Eligibility Criteria
Inclusion Criteria:Ambulatory person who is at least 65 years of ageAbility to understand and provide informed consentAbility to perceive vibrations from the Walkasins Haptic ModuleAbility to complete the functional outcome measures without the use of an assistive deviceFoot size that allows the Walkasins to function appropriatelyMild Cognitive Impairment as measured by the Saint Louis University Mental Status (SLUMS) Exam (scores between 20 and 24 for those with less than a high school education and scores between 21-26 for those who graduated from high school, which indicate mild cognitive impairment)Slow gait speed (<1m/second)Exclusion Criteria:SLUMS scores <20 and >24 for those with less than a high school education and <21 and >26 for those with a high school educationUse of ankle-foot orthosis for ambulation that prevents donning of WalkasinsSelf-reported acute thrombophlebitis including deep vein thrombosisUntreated lymphedemaUntreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product useUntreated fractures in the foot and ankleSelf-reported severe peripheral vascular diseaseOther neurological conditions that impact walking (e.g., peripheral neuropathy)Weighs more than 300 pounds
Source: ClinicalTrials.gov (NCT05723822). StuddyBuddy aggregates publicly available trial information.