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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625789
• Other study ID #: 22-2628
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Chelsea Duppen, DPT
• Phone: 919-966-4041
• Email: chelsea_parker[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Postural control (weight shift) training
Visual cues to improve amplitude of weight shift prior to initiating gait.
• 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.

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	LSVT Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)