Effects of Osteopathic Manipulative Treatment (OMT) on Gait Biomechanics in Parkinson's Disease

NCT03616145 | Unknown

• 1 other identifier: 13517128719
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Osteopathic Manipulative Treatment

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Change in Cognition

  0 weeks, 6 weeks, and 10 weeks

• Change in PD-Related Health Status

  0 weeks, 6 weeks, and 10 weeks

• Change in Depressed Mood

  0 weeks, 6 weeks, and 10 weeks

• Change in Motor Skills

  0 weeks, 6 weeks, and 10 weeks

Study Arms (3)

Osteopathic Manipulative Treatment (OMT)

EXPERIMENTAL

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)

Light Touch

SHAM COMPARATOR

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

Standard of Care Only

NO INTERVENTION

Subjects will continue their usual care and will visit the UCSD for the 4 assessment sessions only, during their course of study participation.

Interventions

Osteopathic Manipulative Treatment (OMT) PROCEDURE

Experimental Condition

Osteopathic Manipulative Treatment (OMT)

Light Touch OTHER

Comparator Arm

Light Touch

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• Ambulatory without use of assistive device.
• Fluency in written and spoken English.
• Montreal Cognitive Assessment (MoCA) score \> or = 17.
• Stages 1 - 4 Parkinson's Disease diagnosis as measured by the Unified Parkinson's disease rating scale.

You may not qualify if:

• Currently enrolled in another clinical trial.
• Current taking PD medications co-morbid conditions such as pseudobulbar palsy or amyotrophic lateral sclerosis which may have musculoskeletal effects.
• Individuals with current fractures, tumors, wounds.
• Any lifetime Deep Brain Stimulation implant surgery.
• Recent surgeries, eg., within past 90 days.
• Patients who have experienced hospitalization due to a fall within the past 12 months.
• Gait abnormalities other than Parkinson's disease.
• Received OMT or another forms of manipulative therapy within the past two months.
• Stage 5 Parkinson's Disease diagnosis per as measured by the Unified Parkinson's disease rating scale.
• Other co-morbid conditions that in the opinion of the PI would interfere with participation in this study.
• Diagnosis of psychosis or dementia (MoCA, DRS or other indication in eMR).
• Pregnancy

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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).

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: August 6, 2018
• Study Start: July 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: January 21, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)