How to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease

The purpose of this study is to understand the treatment approach (i.e., targeting gait or targeting the postural adjustment prior to gait) that is most effective at improving gait initiation dynamics in people with Parkinson disease. Ten adults with idiopathic Parkinson disease who self-report difficulty initiating gait will complete the study. The investigators will be using a randomized crossover design, where the participants will participate in two series of training (i.e., postural training and steady-state gait training) with a one-week washout between trainings. Investigators will evaluate the changes induced in gait initiation postural adjustment size, first step length, and first step speed from each intervention. Due to the anticipated limitation of steady-state walking to directly address postural adjustment amplitude, it is hypothesized that training for larger amplitude weight shift during gait initiation will yield improved gait initiation dynamics compared to training with large amplitude movements during steady-state walking.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Postural control (weight shift) training; Behavioral: Steady state gait training

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of idiopathic Parkinson disease characterized by asymmetrical onset of at least 2 of 3 cardinal signs (resting tremor, bradykinesia, or rigidity) with no atypical signs or exposure to dopamine-blocking drugs
• The presence of mild to moderate gait or balance impairment (a rating of 1-2 on MDS Unified Parkinson Disease Rating Scale (MDS-UPDRS) item 10 [gait] or rating 1-3 on item 12 [postural stability]
• Hoehn & Yahr stages 1-3 ("on" for those who fluctuate)
• Self-report of difficulty with freezing of gait (i.e., a rating of 1-4 on question 3 of the Freezing of Gait Questionnaire)
• All participants must be able to walk > 5 minutes at greater than or equal to 80% of comfortable gait speed (CGS) on the treadmill and > 5 minutes over ground without assistance or an assistive device.

Exclusion Criteria:

• Uncontrolled cardiorespiratory/metabolic disease, vestibular dysfunction that may affect gait or balance
• Parkinson's related or unrelated dementia (i.e. Montreal Cognitive Assessment score <21)
• Comfortable over ground walking speed of less than 0.5m/s
• History of traumatic brain injury
• self-reported deafness or blindness as this would impair the patient's ability to hear cues or ambulate safely within the lab environment
• other neurological disorders or orthopedic injury that may affect gait
• recent orthopedic surgery (in the last 6 months)
• Participants will also be excluded if they have severe communication impairments, which could impede understanding of the purpose or procedures of the study or an inability to comply with experimental procedures
• Participants who are currently receiving supervised physical therapy services

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postural control (weight shifting) training followed by steady state gait training.; For postural control training, participants will be provided visual biofeedback to increase weight shift prior to the first step. The feedback program cues participants to reach a target amount of weight shift. Once the target is reached, participants are cued to initiate walking. Participants will complete a total of 30 minutes of training, ensuring at least 45 repetitions. To create larger amplitude movements during steady state gait, participants will walk on a treadmill set to their comfortable gait speed while attempting to match their steps to a metronome beeping at 85% of their comfortable cadence. Participants will complete a total of 10 minutes of treadmill walking with rest breaks as needed. Next, participants will walk overground to a metronome beeping at 115% of their comfortable cadence with a goal of 10 total minutes of training. Each training will be three times per week for two weeks. There is a one week break between the two trainings.	Behavioral: Postural control (weight shift) training; Visual cues to improve amplitude of weight shift prior to initiating gait.; Behavioral: Steady state gait training; Auditory cues are provided to increase amplitude of movement (e.g., step length) during continuous walking, to determine its effects on gait initiation amplitude of movement.
Experimental: Steady state gait training followed by postural control (weight shifting) training.; To create larger amplitude movements during steady state gait, participants will walk on a treadmill set to their comfortable gait speed while attempting to match their steps to a metronome beeping at 85% of their comfortable cadence. Participants will complete a total of 10 minutes of treadmill walking with rest breaks as needed. Next, participants will walk overground to a metronome beeping at 115% of their comfortable cadence with a goal of 10 total minutes of training. For postural control training, participants will be provided visual biofeedback to increase weight shift prior to the first step. The feedback program cues participants to reach a target amount of weight shift. Once the target is reached, participants are cued to initiate walking. Participants will complete a total of 30 minutes of training, ensuring at least 45 repetitions. Each training will be three times per week for two weeks. There is a one week break between the two trainings.	Behavioral: Postural control (weight shift) training; Visual cues to improve amplitude of weight shift prior to initiating gait.; Behavioral: Steady state gait training; Auditory cues are provided to increase amplitude of movement (e.g., step length) during continuous walking, to determine its effects on gait initiation amplitude of movement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in First Step Length from Baseline to Conclusion of the first block of training	Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).	Baseline, at the conclusion of the first block of training (approximately 2 weeks)
Change in First Step Length from end of first block of training to training 2 pre-test	Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).	Conclusion of first training block, just prior to beginning the second training series (1 week)
Change in First Step Length from training block 2 pre-test to conclusion of second block of training	Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).	Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)
Change in First Step Length from conclusion of second training block to 1 week follow up from second training block	Length of the first step during gait initiation (i.e., distance from stepping limb heel marker at quiet stance to heel marker of stepping limb at heel strike of the first step forward).	Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from Baseline to Conclusion of the first block of training	Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).	Baseline, at the conclusion of the first block of training (approximately 2 weeks)
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from end of first block of training to training 2 pre-test	Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).	Conclusion of first training block, just prior to beginning the second training series (1 week)
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from training block 2 pre-test to conclusion of second block of training	Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).	Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)
Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from conclusion of second training block to 1 week follow up from second training block	Center of pressure displacement towards the stepping limb from quiet stance until toe off of the stepping limp (i.e., the initiation of gait).	Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)
Change in First Step Speed from Baseline to Conclusion of the first block of training	First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.	Baseline, at the conclusion of the first block of training (approximately 2 weeks)
Change in First Step Speed from end of first block of training to training 2 pre-test	First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.	Conclusion of first training block, just prior to beginning the second training series (1 week)
Change in First Step Speed from training block 2 pre-test to conclusion of second block of training	First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.	Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)
Change in First Step Speed from from conclusion of second training block to 1 week follow up from second training block	First step speed is measured by dividing the first step length by the time it takes to take the first step - which is calculated as the time from toe off of the stepping limb to heel strike of the stepping limb.	Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: LSVT Global
• Investigators: Study Director: Michael Lewek, PhD, UNC Chapel Hill; Principal Investigator: Chelsea P Duppen, DPT, UNC Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): August 9, 2024
• Study Completion (Actual): August 9, 2024

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Freezing of Gait; Gait Initiation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 22-2628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning after publication to five years following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
• IPD Sharing Time Frame: Results will be shared following publication and up to five years following publication.
• IPD Sharing Access Criteria: The investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and must execute a data use/sharing agreement with the University of North Carolina at Chapel Hill.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No