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

NCT ID: NCT04946760

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2019-09-16

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. 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. 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.

Detailed Description

Disordered health does not simply progress in one direction from disease process, to disability, to handicap; rather, the process is a complex interaction between health conditions, body structure and function, environmental and personal factors, and limitations in activity and participation. Biologic,behavioral, environmental, and socioeconomic risk factors can all contribute to this progression. In the case of Parkinson disease (PD), this progression includes the degradation of balance and stability resulting in falls. Parkinson disease (PD) is the second most common neurodegenerative disease worldwide. It results from a lack of dopamine production within the substantia nigra, and is characterized by slowness of movement (bradykinesia), muscle rigidity (akinesia), postural instability, and resting tremor. As a result, PD patients have a characteristic short shuffling gait, with a loss of associated arm motion. Gait initiation is difficult and sudden freezing may impair components of movement such as turning. Postural instability and gait difficulty increase over the course of the disease, and expose PD patients to a nine times greater risk of falls. Falls can cause physical injuries such as fractures and/or head injuries leading to functional incapacity, increased risk of nursing home admission and higher mortality rate. Musculoskeletal manifestations of PD may be as impactful as the nervous system manifestations. For example, muscle rigidity associated with dopaminergic loss can lead to somatic dysfunction, which can impact posture and gait. Osteopathic medicine, with its philosophical understanding of the central role of the musculoskeletal system, is in an ideal model for this direction of research. Recent evidence has demonstrated OMT's efficacy in improving postural control in healthy older subjects. Wells et al., were the first to examine the effects of an OMT protocol in a cohort of persons with PD. While this study demonstrated a positive effect on gait kinematics, it investigation failed to examine static components of postural control, which are the most common cause of falls in PD.

The investigators have carefully designed this study to identify the effects that an OMT protocol has on gait kinematics and postural control in subjects with PD. This design compares the effectiveness of two OMT protocols: the Neck-Down (OMT-ND) protocol focuses on addressing biomechanical dysfunctions from the neck down; and the Whole-Body (OMT-WB) protocol, includes the ND techniques and adds specific Osteopathic Cranial Manipulative Medicine (OCMM) techniques to address dysfunctions in the head.

The investigators hypothesize that the application of an OMT protocol will improve gait kinematics and increase subjects' ability to respond to a postural challenge due to improved joint flexibility, improved proprioception and decreased muscle coactivation. 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.

The investigators also include a sham group to strengthen the internal validity of the OMT- ND and OMT-WB protocols. Research on OMT's specific effects is sometimes difficult to differentiate from placebo effects. Distinct placebo components include assessment and observation, therapeutic ritual, and a supportive patient-practitioner relationship. The sham treatment will control for these components with minimal impact on the biomechanical dysfunctions in our subjects.

The investigators plan to investigate the effect of these OMT protocols via the following specific aims:

1. Identify the effects of a Neck-down OMT protocol (OMT-ND) on gait kinematics and postural control in Parkinson disease;

2. Determine the efficacy of a Whole-body OMT protocol (OMT-WB) including cranial manipulation on gait kinematics and postural control in Parkinson disease.

The investigators' long-term goal is create a reproducible protocol that improves gait and postural control, and helps to reduce falls and improve quality of life in persons with PD. If the results validate the previous studies and prove the hypotheses, this study will advance osteopathic medicine by demonstrating OMT as a useful adjunct treatment in patients with PD. The investigators' expectation is that by improving gait and postural control, OMT can help PD patients reduce falls, which may allow them to be more active and lead a better quality of life.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham Protocol

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.

Group Type: SHAM_COMPARATOR

Sham Manipulation

Intervention Type: 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.

Whole-Body Protocol

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

Group Type: EXPERIMENTAL

Sham Manipulation

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Sham Manipulation

Intervention Type: 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.

Interventions

Sham Manipulation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Osteopathic Association

OTHER

Sponsor Role: collaborator

University of North Texas Health Science Center

OTHER

Sponsor Role: lead

Responsible Party

Kendi Hensel, DO, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of North Texas Health Science Center

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

#2016-097

Identifier Type: -

Identifier Source: org_study_id