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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with Parkinson's disease and Freezing of Gait using experimental insole and haptic module |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haptic module and insole device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial. | Change in duration of FOG events. Decreased duration of FOG events indicates higher efficacy of device system. | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Participants aged 45-80 who have a diagnosis of Parkinson's disease with Freezing of Gait symptoms who live in the community.
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| Name | Affiliation | Role |
|---|---|---|
| Martha A Nance, MD | Struthers Parkinson's Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Struthers Parkinson's Center | Golden Valley | Minnesota | 55427 | United States | ||
| HealthPartners Neuroscience Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | People With Parkinson's Disease and Freezing of Gait Using Experimental Insole and Haptic Module | Haptic 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | People With Parkinson's Disease and Freezing of Gait Using Experimental Insole and Haptic Module | Haptic 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial. | Change in duration of FOG events. Decreased duration of FOG events indicates higher efficacy of device system. | Some withdrawn participants and those with device issues were not included in the analysis as we were unable to calculate the freezing of gait (FOG) events. | Posted | Mean | Standard Deviation | seconds | 5 weeks |
|
5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | People With Parkinson's Disease and Freezing of Gait Using Experimental Insole and Haptic Module | Haptic 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Hospitalization for confusion due to pneumonia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Coordinator | HealthPartners Institute Neuroscience Research | 6514956363 | clinicaltrials@healthpartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2024 | Apr 29, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Saint Paul |
| Minnesota |
| 55130 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education Level | Count of Participants | Participants |
|
Haptic 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.
|
|
| 0 |
| 31 |
| 1 |
| 31 |
| 8 |
| 31 |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pain (e.g. joint, muscle, nerve) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |