NCT05625789Completed
How to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease
Source: ClinicalTrials.gov · Last updated 20 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 15 Nov 2022
- Start date
- 10 Jan 2022
- Primary completion date
- 9 Aug 2024
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Parkinson disease
- NCT number
- NCT05625789
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 10 Jan 2022 to the primary completion date, 9 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- recent orthopedic surgery (in the last 6 months)
- Participants who are currently receiving supervised physical therapy services
Other illness
- 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)
- History of traumatic brain injury
- other neurological disorders or orthopedic injury that may affect gait
Other
- Comfortable over ground walking speed of less than 0.5m/s
- self-reported deafness or blindness as this would impair the patient's ability to hear cues or ambulate safely within the lab environment
- 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
Who the study is looking for
- 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.
Age in the registry: 35 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNC- Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.