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Clinical Trials/NCT05625789
NCT05625789
Recruiting
Not Applicable

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

University of North Carolina, Chapel Hill1 site in 1 country10 target enrollmentJanuary 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of North Carolina, Chapel Hill
Enrollment
10
Locations
1
Primary Endpoint
Change in First Step Length from Baseline to Conclusion of the first block of training
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2022
End Date
June 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in First Step Length from Baseline to Conclusion of the first block of training

Time Frame: Baseline, at the conclusion of the first block of training (approximately 2 weeks)

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).

Change in First Step Length from end of first block of training to training 2 pre-test

Time Frame: Conclusion of first training block, just prior to beginning the second training series (1 week)

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).

Change in First Step Length from conclusion of second training block to 1 week follow up from second training block

Time Frame: Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week)

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).

Change in First Step Length from training block 2 pre-test to conclusion of second block of training

Time Frame: Prior to beginning second block of training, at the conclusion of second block of training (2 weeks)

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).

Secondary Outcomes

  • Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from end of first block of training to training 2 pre-test(Conclusion of first training block, just prior to beginning the second training series (1 week))
  • Change in First Step Speed from Baseline to Conclusion of the first block of training(Baseline, at the conclusion of the first block of training (approximately 2 weeks))
  • Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from Baseline to Conclusion of the first block of training(Baseline, at the conclusion of the first block of training (approximately 2 weeks))
  • Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from training block 2 pre-test to conclusion of second block of training(Prior to beginning second block of training, at the conclusion of second block of training (2 weeks))
  • Change in First Step Speed from training block 2 pre-test to conclusion of second block of training(Prior to beginning second block of training, at the conclusion of second block of training (2 weeks))
  • Change in First Step Speed from end of first block of training to training 2 pre-test(Conclusion of first training block, just prior to beginning the second training series (1 week))
  • Change in Mediolateral Anticipatory Postural Adjustment (APA) Size from conclusion of second training block to 1 week follow up from second training block(Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week))
  • Change in First Step Speed from from conclusion of second training block to 1 week follow up from second training block(Conclusion of second training block, 1 week follow up from conclusion of second training block (1 week))

Study Sites (1)

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