Effects of OMT on Gait Kinematics and Postural Control in Parkinson Disease

NCT04946760 | Completed

• 1 other identifier: #2016-097
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson Disease is a degenerative process that affects millions each year, and has devastating effects on patients and their families. The mobility symptoms that manifest as the disease progresses can result in social isolation as patients may be embarrassed or fear falling in public. One of the common risks resulting from the PD is falls. Falling in PD is primarily related to musculoskeletal issues such as muscular rigidity, postural instability \& stooped posture. These kinds of manifestations should be amenable to treatment with OMT. There are studies showing the positive impact that OMT has on gait in PD, and a study showing improvement in balance in non-PD subjects. This investigation is designed to address these components via the following specific aims:

1. 1.Identify the effects of a Neck-down OMT (OMT-ND) protocol on gait kinematics and postural control in Parkinson disease The investigators hypothesize that the application of an OMT protocol will improve gait kinematics and increase subjects' ability to respond to a postural challenge. The theoretical mechanism for this is due to the improved joint flexibility, improved proprioception and decreased muscle co-activation.
2. 2.Determine the efficacy of Whole-body OMT (OMT-WB) protocol including cranial manipulation on gait kinematics and postural control in Parkinson disease The investigators hypothesize that the addition of a cranial manipulation protocol will further improve gait kinematics and increase subjects' ability to respond to a postural challenge. The theoretical mechanism for this is due to the improved arterial blood flow to the brain, which results from improving the cranial bone motion, maximizing venous drainage, and reducing any restrictions around the vestibular system.

Conditions

Parkinson Disease

Keywords

Osteopathic Manipulation

Outcome Measures

Primary Outcomes (2)

• Timed up and Go test

  The "Timed Up and Go" Test (TUG), which measures the ability of participants to perform sequential mobility tasks that incorporate walking and turning. Specifically, in this timed test, participants begin in a seated position in an armchair. They are asked to rise, go forward 3m, turn around and sit back down. In older adults at risk for falls and persons with PD, the TUG has been found to possess excellent intra-tester reliability (0.94-0.96) and predictive validity, with increased times on the TUG relating to higher fall-risk.

  Pre and immediately post intervention, change will be reported

• Functional Reach Test

  The functional reach test (FR) is a simple balance task that tests the ability of a person to move their center of mass to the anterior limits of their base of support by measuring the distance a participant can reach forward from a quiet stance position. \[Duncan, 1990; Duncan, 1992\] The FR distance has previously been demonstrated to be predictive of fall risk in elderly persons, possess excellent test-retest reliability,\[Brusse, 2005; Steffen, 2005\] and can distinguish between those persons with PD with a history of falls from those with no falling history.

  Pre and immediately post intervention, change will be reported

Secondary Outcomes (2)

• Gait kinematics

  Pre and immediately post intervention, change will be reported

• Postural control

  Pre and immediately post intervention, change will be reported

Study Arms (3)

Sham Protocol

SHAM COMPARATOR

The sham protocol will consist of examination of the subject's active and passive range of motion in the spine and extremities, in the joints that would have been treated with OMT. The subject will be positioned in sitting, supine and lateral recumbent in a similar manner to that of the OMT group, but without providing an active intervention. To provide a sham for the OMT-WB protocol, subjects will lie supine with the physician's hands under the occiput, palms toward the table, so that the subject's head rests on the dorsal aspect of the physician's hands. The time used in the sham procedures will be approximately 20-25 minutes.

Other: Sham Manipulation

Whole-Body Protocol

EXPERIMENTAL

The whole-body protocol will include all the techniques in the OMT-ND protocol, but will also include techniques focused on the expected cranial dysfunctions \[Rivera-Martinez 2002\]. The OMT-WB protocol will last approximately 25-30 minutes. The techniques will include: * Evaluation for strain pattern(s) * Occipitolatlantal decompression * Sphenobasilar synchondrosis decompression * Occipitomastoid suture V-spread * Temporal bone balancing * Venous sinus drainage technique

Other: Sham Manipulation

Neck-down protocol

EXPERIMENTAL

The neck-down protocol takes into consideration previous relevant studies \[Lopez 2011, Wells 1999\]. OMT will be used bilaterally on the following areas with one or more techniques, including myofascial release, articulatory, muscle energy, and balanced ligamentous tension. The OMT-ND protocol will last approximately 15-20 minutes. * Cervical spine * Thoracic spine * Lumbar spine * Shoulder girdle * Sacroiliac joint * Innominates * Leg muscles (including psoas, piriformis, hamstring, adductors) * Ankles

Other: Sham Manipulation

Interventions

Sham Manipulation OTHER

The sham protocol will consist of examination of the subject's active and passive range of motion in the spine and extremities, in the joints that would have been treated with OMT. The subject will be positioned in sitting, supine and lateral recumbent in a similar manner to that of the OMT group, but without providing an active intervention.

Neck-down protocol; Sham Protocol; Whole-Body Protocol

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For PD participants: Neurologist-diagnosed idiopathic PD, H\&Y stages 1.0-3.0
• Ability to stand independently for 1 minute and ambulate 100 yards independently
• Healthy (not under ongoing medical care for health problems that could impact performance on study tasks)
• for controls: age-matched healthy adults

You may not qualify if:

• Idiopathic PD in Hoehn \& Yahr stages \>3.0
• Previous surgical management of PD (pallidotomy, deep brain stimulation
• Central or peripheral nervous system disorders other than PD including, but not limited to multiple sclerosis, cerebral palsy, Alzheimer's diseases, or chronic fatigue syndrome
• Cognitive impairment as defined by the Mini-Mental Status Examination (\<26 for subjects with PD and \<24 for control subjects)
• Unable to stand independently for 1 minute and to walk independently for 100 yards
• Body weight \>400lbs

Sponsors & Collaborators

• University of North Texas Health Science Center: lead
• American Osteopathic Association: collaborator

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 1, 2021
• Study Start: September 1, 2016
• Primary Completion: September 15, 2019
• Study Completion: September 16, 2019
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)