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临床试验/NCT05625789
NCT05625789招募中不适用

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

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
2
主要终点
Change in First Step Length from Baseline to Conclusion of the first block of training

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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