Phase
Condition
Stroke
Cerebral Ischemia
Treatment
MR-001
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Equal to or greater than 6 months post-stroke with gait impairment
Age >/= 18 - 85 years of age, inclusive
Understand and speak English
Must be able to ambulate without assistance from another person. Note: assistivedevices are allowed. If a participant uses an assistive device at the time ofenrollment, the device must be used for all walking sessions.
Willing to travel to a Velocity location to complete in-person gait assessments
Able to walk at a speed greater than or equal to 0.4 m/s as derived as an average ofspeed per minute from the 6MWT. Note: if a participant intends to use an assistivedevice throughout the intervention period, the assistive device must be used duringthe gait assessment.
Must have claims data available and consent to sharing.
Exclusion
Exclusion Criteria:
Hearing impairment with or without the use of hearing aids such that the participantcannot hear the rhythmic stimulation of the music
Pain that impairs walking ability
Unable to safely participate in walking sessions as determined by investigator
Requires more than one rest (seated or not) during the 6MWT
Significant comorbid medical or neurological conditions that could impact gait orprevent safe participation as determined by the Investigator. For example: conditionthat prevents participation in exercise, e.g., Parkinson's disease, cerebral palsy,multiple sclerosis, myasthenia gravis, muscular dystrophy, or spinal cord injury.Note: major surgery within the last 3 months is exclusionary.
People who are pregnant or become pregnant (due to expected gait pattern changes).
Lower limb prosthetic
More than 2 falls in the previous month
Non-reciprocal gait pattern. Note: Note: a non-reciprocal gait pattern is defined asa 3-point step pattern. Participants must have a 2-point step pattern to qualify.Asymmetry seen in gait is acceptable.
Treatment with a gait-based investigational intervention within the last 3 months.
Unable or unwilling to provide informed consent to participate
Study Design
Study Description
Connect with a study center
Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL
Portland, Maine 04101
United StatesSite Not Available
Curavit Clinical Research - DECENTRALIZED CLINICAL TRIAL
Portland 4975802, Maine 4971068 04101
United StatesSite Not Available

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