Clinical trial NCT05625789: How to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease
Official title: How to Get Started: Identifying the Critical Ingredients to Improve Gait Initiation in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Freezing of Gait
Gait Initiation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: LSVT Global
First posted: 2022-11-23
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in First Step Length from Baseline to Conclusion of the first block of training
timeFrame: Baseline, at the conclusion of the first block of training (approximately 2 weeks)
measure: Change in First Step Length from end of first block of training to training 2 pre-test
timeFrame: Conclusion of first training block, just prior to beginning the second training series (1 week)
measure: Change in First Step Length from training block 2 pre-test to conclusion of second block of training
timeFrame: Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)
measure: Change in First Step Length from conclusion of second training block to 1 week follow up from second training block
timeFrame: Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)
Secondary outcomes:
measure: Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from Baseline to Conclusion of the first block of training
timeFrame: Baseline, at the conclusion of the first block of training (approximately 2 weeks)
measure: Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from end of first block of training to training 2 pre-test
timeFrame: Conclusion of first training block, just prior to beginning the second training series (1 week)
measure: Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from training block 2 pre-test to conclusion of second block of training
timeFrame: Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)
measure: Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from conclusion of second training block to 1 week follow up from second training block
timeFrame: Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)
measure: Change in First Step Speed from Baseline to Conclusion of the first block of training
timeFrame: Baseline, at the conclusion of the first block of training (approximately 2 weeks)
measure: Change in First Step Speed from end of first block of training to training 2 pre-test
timeFrame: Conclusion of first training block, just prior to beginning the second training series (1 week)
measure: Change in First Step Speed from training block 2 pre-test to conclusion of second block of training
timeFrame: Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)
measure: Change in First Step Speed from from conclusion of second training block to 1 week follow up from second training block
timeFrame: Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Michael Lewek, PhD
role: STUDY_DIRECTOR
affiliation: UNC Chapel Hill
name: Chelsea P Duppen, DPT
role: PRINCIPAL_INVESTIGATOR
References: