Parkinson Disease
Conditions
Keywords
Freezing of Gait
Brief summary
The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing.
Interventions
DEVICEHaptic module and insole device
System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.
Sponsors
HealthPartners Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Ability to provide and provision of signed and dated informed consent form. * Age 45 or older * Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria. * Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and New Freezing of Gait Questionnaire (NFOG). * Able to complete a 2-minute walk test at the pre-treatment visit. * Currently on a stable prescription medication regimen for PD and willing to adhere to the regimen during the study. * Ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention.
Exclusion criteria
* Non-English speaking * History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment. * Other significant neurological disorders that may affect participation or performance in the study. * Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module. * Hallucinations * Non-ambulatory * Legally Blind * Symptomatic hypotension * Any condition which would limit sensation in the legs or requires use of wraps, bandages or other items which may limit sensation in the legs (e.g., lymphedema) that would interfere with the performance of the haptic device, in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial. | 5 weeks | Change in duration of FOG events. Decreased duration of FOG events indicates higher efficacy of device system. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMartha A Nance, MD
Struthers Parkinson's Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Education Level Associate's Degree | 6 Participants |
| Education Level Bachelor's Degree or Higher | 16 Participants |
| Education Level No formal education | 0 Participants |
| Education Level Primary level education | 0 Participants |
| Education Level Secondary level education/GED/Equivalent | 1 Participants |
| Education Level Some College | 6 Participants |
| Education Level Trad/Vocational Training | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 8 / 31 |
| serious Total, serious adverse events | 1 / 31 |
Outcome results
None listed