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

Completed · Not applicable

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT05625789

Run by

University of North Carolina, Chapel Hill

People needed

10

Starts

2022-01-10

Expected to finish

2024-08-09

Last updated by the study team

2024-09-20

Who can join

Age: 35 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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