Healthy, Huntington Disease
Conditions
Keywords
Huntington Disease
Brief summary
MEND-HD is a longitudinal study evaluating the feasibility of passive monitoring of gait and chorea in patients with HD and the meaningfulness of these outcomes for patients with HD and their care partners/support persons. Participants will take part in four virtual visits with study investigators to answer survey questions on movement and cognition, perform in-home movement assessments, and take part in an interview regarding the meaningfulness of gait and chorea in their daily lives. Participant and care partner interviews will be used for symptom mapping and qualitative data analysis to assess the relevance and impact of the targeted symptoms on the participant's daily life. The study may be extended to 3 years to include yearly visits.
Interventions
DEVICEActiGraph LEAP
The ActiGraph LEAP has received 510(k) clearance from the US FDA and offers extensive sensor collections, providing continuous digital measures of activity, sleep, mobility, and additional vital signs, including heart rate and variability, oxygen saturation, and skin temperature, in a single fit-for-purpose device.
DEVICEAxivity AX6
The Axivity AX6 is a data logger capable of recording raw data from a suite of integrated sensors. It features a state of the art 6-Axis movement sensor measuring linear acceleration and angular velocity at high precision. All sensor locations and Orientations are identical to the AX3 for maximum compatibility. All data is stored in its raw, unaltered format on the embedded flash memory.
Sponsors
University of Rochester
Food and Drug Administration (FDA)
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for participants with adult-onset HD: * Age of 25-65 years. * Genetically confirmed HD with CAG \>= 40 (HD-ISS Stage 2 or mild/moderate Stage 3) * English speaking. Inclusion Criteria for control participants: * Age of 25-65 years. * English speaking. Inclusion Criteria for support persons: * Self-identified support person or family member of the enrolled participants with HD. * 18 years or older * English speaking.
Exclusion criteria
* Diagnosis of juvenile-onset HD. * History of co-morbid neurological disease or disorders such as stroke, multiple sclerosis, or moderate to severe * Traumatic Brain Injury. * Use of an assistive device for ambulation. * Montreal Cognitive Assessment (MoCA) score of 18 or lower * Acute or chronic medical conditions that significantly impact gait or mobility in the opinion of the investigator, e.g. ankle sprain or fracture, or any orthopedic, * cardiovascular or psychiatric disease. * Pregnancy * Cannot be enrolled into a blinded intervention trial at Baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-Method Reliability of Total Time in Chorea (Trunk-Worn vs. Wrist-Worn Device) | 1 week | Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants. |
| Known Group Validity of Total Time in Chorea (Trunk-Worn Device) | 1 week | Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants. |
| Known Group Validity of Total Time in Chorea (Wrist-Worn Device) | 2 weeks | Total time in chorea is calculated by summing the duration of all bouts of detected chorea throughout each day and then summed across the week (normalized to wear time). The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants. |
| Inter-Method Reliability of Stride Time Variability (Trunk-Worn vs. Wrist-Worn Device) | 1 week | Stride time variability is defined as the coefficient of variation of stride time, with the median value calculated across all walking bouts lasting at least 10 seconds. The outcome will assess the agreement between trunk-worn and wrist-worn devices among HD and control participants. |
| Known Group Validity of Stride Time Variability (Trunk-Worn Device) | 1 week | Stride time variability is defined as the coefficient of variation of stride time, with the median value calculated across all walking bouts lasting at least 10 seconds. The outcome will assess the ability of the trunk-worn device to differentiate between HD and control participants. |
| Known Group Validity of Stride Time Variability (Wrist-Worn Device) | 2 weeks | Stride time variability is defined as the coefficient of variation of stride time, with the median value calculated across all walking bouts lasting at least 10 seconds. The outcome will assess the ability of the wrist-worn device to differentiate between HD and control participants. |
Countries
United States
Contacts
CONTACTSugitha Maheswaran, BS
Outcome results
None listed