Parkinson Disease Clinical Trial
— (OMT/PD)Official title:
Effects of Osteopathic Manipulative Treatment (OMT) on Gait Biomechanics in Parkinson's Disease (OMT/PD)
Verified date | November 2023 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Parkinson's disease (PD) is a neurological disorder that puts individuals at high risk for injuries and long-term disabilities as a result of a fall or other trauma. Injuries sustained from falls account for many deaths as well as thousands of hospital admissions and nursing home stays every month. Quality of life and even longevity itself is reduced due to the resulting surgeries, immobility, complications and even cognitive impairments that can follow. The proposed study will explore beneficial impact of a treatment modality (OMM/OMT) that may significantly reduce the morbidity of this condition by comparing 6 weeks of OMT versus 6 weeks light touch intervention versus 6 weeks care as usual to improve gait in individuals with PD. Gait will be measured at mid-treatment, post-treatment and 4-week follow-up.
Status | Active, not recruiting |
Enrollment | 94 |
Est. completion date | January 21, 2024 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age > 18 years. 2. Ambulatory without use of assistive device. 3. Fluency in written and spoken English. 4. Montreal Cognitive Assessment (MoCA) score > or = 17. 5. Stages 1 - 4 Parkinson's Disease diagnosis as measured by the Unified Parkinson's disease rating scale. Exclusion Criteria: 1. Currently enrolled in another clinical trial. 2. Current taking PD medications co-morbid conditions such as pseudobulbar palsy or amyotrophic lateral sclerosis which may have musculoskeletal effects. 3. Individuals with current fractures, tumors, wounds. 4. Any lifetime Deep Brain Stimulation implant surgery. 5. Recent surgeries, eg., within past 90 days. 6. Patients who have experienced hospitalization due to a fall within the past 12 months. 7. Gait abnormalities other than Parkinson's disease. 8. Received OMT or another forms of manipulative therapy within the past two months. 9. Stage 5 Parkinson's Disease diagnosis per as measured by the Unified Parkinson's disease rating scale. 10. Other co-morbid conditions that in the opinion of the PI would interfere with participation in this study. 11. Diagnosis of psychosis or dementia (MoCA, DRS or other indication in eMR). 12. Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Gait | Gait analysis will be conducted using the Timed Up and Go while wearing the LEGsys+ system. The Legsys body worn sensor system utilizes state-of-the-art camera-based motion capture allowing measurement of advanced gait parameters including stride duration and length, step length, speed, cadence, sagittal plane knee and hip angles, and superior-inferior and medial-lateral pelvis movement, as well as a fall risk assessment. | 0 weeks, 6 weeks, and 10 weeks | |
Primary | Change in Balance | Balance will be measured via the NeuroCom SMART EquiTest system, which enables enables the isolation and assessment of the sensory and muscular components of balance. | 0 weeks, 6 weeks, and 10 weeks | |
Secondary | Change in Cognition | The Montreal Cognitive Assessment (MoCA) will be administered as a measure of general cognition and will be used as a covariate in the statistical analyses (please see Data Analysis section below). The MoCA is a suitably accurate, brief (10-minute) test of cognitive impairment in PD and has established cut-offs for both MCI and PDD. | 0 weeks, 6 weeks, and 10 weeks | |
Secondary | Change in PD-Related Health Status | Parkinson's Disease Questionnaire-39 (PDQ-39) is a self-report measure of health status (HS), which is considered different than QoL in that it does not ask for perceptions, judgments or reactions. It consists of 39 questions rated by the subject on a five-item likert scale (Never, Occasionally, Sometimes, Often, or Always) and takes approximately 10 minutes to complete. From these questions, eight subscale (Mobility, Activities of Daily Living, Emotional Well-Being, Stigma, Social Support, Cognition, Communications, and Bodily Discomfort) scores are derived by summing the item scores for each subscale, dividing the sum by the highest possible score for that subscale and then multiplying this number by 100. Higher scores correspond to worse HS. | 0 weeks, 6 weeks, and 10 weeks | |
Secondary | Change in Depressed Mood | Geriatric Depression Scale (GDS) is a self report questionnaire comprised of 30 yes or no questions used to identify depression in the elderly. Total scores range from 0 to 30 where higher scores reflect more severe depression 11 . | 0 weeks, 6 weeks, and 10 weeks | |
Secondary | Change in Motor Skills | The Movement Disorder Society-The Unified Parkinson's disease Rating Scale (MDS- UPDRS Part Three). For this assessment participants go through a series of tasks designed to assess various motor characteristics such as speech, facial expression, rigidity, finger tapping, hand movements, toe tapping, freezing of gait, etc. All scores for each component range from 0 to 4 and summed for a grand total 4 | 0 weeks, 6 weeks, and 10 weeks |
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