Effects of Osteopathic Manipulative Treatment (OMT) on Gait Biomechanics in Parkinson's Disease ((OMT/PD))
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|ClinicalTrials.gov Identifier: NCT03616145|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Procedure: Osteopathic Manipulative Treatment (OMT) Other: Light Touch||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The overall design proposed in this study is a randomized, placebo controlled, single-blind controlled trial. Data will be collected in this developmental study to assess potential differences in gait, balance, and quality of life of patients in the intervention arm (6-week OMT intervention coupled with standard of care (SOC) versus the light touch comparator arm (6-week light touch coupled with SOC) versus the non-intervention control arm (SOC alone).|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Blinding. The PI, statistician, recruitment personnel, research assistants conducting the assessment sessions, and data entry/verification clerks will be blind to participant's group assignment until data is unlocked at the end of the study. Only the Project Manager who will develop and oversee the randomization procedure, prepare progress reports, and inform participants of their treatment condition will be unblinded.|
|Official Title:||Effects of Osteopathic Manipulative Treatment (OMT) on Gait Biomechanics in Parkinson's Disease (OMT/PD)|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Osteopathic Manipulative Treatment (OMT)
Participants assigned to the OMT arm will receive 6 weekly sessions. The provider will perform the following 14 osteopathic procedures 1) lateral (and anteroposterior) translation of vertebrae in the thoracic/lumbar spine; 2) active myofascial stretch to the thoracic spine; 3) occipito-atlanto release; 4) translation of cervical spine; 5) muscle energy techniques of the cervical spine; 6) Spencer technique applied to the shoulder bilaterally; 7) supination/pronation of the forearm; 8) circumduction of the wrist; 9) sacroiliac joint gapping; 10) muscle energy technique applied to adductor muscles of lower extremity; 11) psoas muscle energy technique; 12) hamstring muscle energy technique; 13) articulatory technique applied to the ankle; 14) and muscle energy technique applied to the ankle in dorsi and plantar flexion. Further, each subject will receive cranial assessment and treatment emphasizing the venous sinus techniques and compression of the fourth ventricle (CV-4).
Procedure: Osteopathic Manipulative Treatment (OMT)
Sham Comparator: Light Touch
Participants assigned to the light touch comparator arm will receive 30 minutes of light touch procedures designed to be credible but minimally effective. The procedures for the light touch arm are adapted from the methodology established in the North Texas Chronic Low Back Pain Trial, and have been used successfully by the PI as a comparator arm numerous times in the past (e.g., in the OSTEPAThic Trial). Subjects assigned to receive light touch will be treated in positions similar to subjects receiving OMT. Light touch will target each of the 15+ anatomic regions for approximately 1 ½ to 2 minutes each to appropriately control for time, attention, and physical contact. Light touch hand placement will be over the same areas of the body contacted in the OMT protocol, but involve virtually no motion of a meaningful nature, such a range of motion testing which could have therapeutic effect.
Other: Light Touch
No Intervention: Standard of Care Only
Subjects will continue their usual care and will visit the UCSD for the 4 assessment sessions only, during their course of study participation.
- Change in Gait [ Time Frame: 0 weeks, 6 weeks, and 10 weeks ]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.
- Change in Balance [ Time Frame: 0 weeks, 6 weeks, and 10 weeks ]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.
- Change in Cognition [ Time Frame: 0 weeks, 6 weeks, and 10 weeks ]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.
- Change in PD-Related Health Status [ Time Frame: 0 weeks, 6 weeks, and 10 weeks ]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.
- Change in Depressed Mood [ Time Frame: 0 weeks, 6 weeks, and 10 weeks ]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 .
- Change in Motor Skills [ Time Frame: 0 weeks, 6 weeks, and 10 weeks ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616145
|Contact: Meredith A Pung, PhDfirstname.lastname@example.org|
|Contact: Hollis H King, DO, PhDemail@example.com|
|United States, California|
|University of California, San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: M. Pung, PhD firstname.lastname@example.org|