Orthotics and Parkinson's Disease: The Acute and Long-term Effects of Increased Somatosensory Feedback
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Postural Sway during Static Stance
研究概览
简要总结
The purpose of this study is to increase clinical knowledge of the relationship between increased plantar sensory information and orthotics in a Parkinsonian gait. The objectives of this study are to determine if orthotics, with and without a textured top cover, can alter muscle activation, gait parameters, balance, functional mobility, and decrease fall risks in Parkinson's participants.
详细描述
The purpose of this study is to increase clinical knowledge of the relationship between increased plantar sensory information and orthotics in a Parkinsonian gait. Observing gait parameters and muscle activation changes, in orthotics with and without a textured top cover, provides an increased understanding of conservative treatment options available to the Parkinson's population. It is hypothesized that balance and functional mobility in Parkinson's Disease (PD) patients will increase, while decreasing fall risks, when wearing both types of orthotics. Larger improvements are expected with the orthotics with a textured top cover, thus increasing plantar sensory feedback. Male and female participants, aged 55-75, with a diagnosis of idiopathic Parkinson's disease can participate in the study. Two types of orthotic design will be examined: 1) Customizable over-the-counter orthotics and 2) Customizable over-the-counter orthotics with a textured top cover. Five different assessments will be performed during three different testing sessions: 1) baseline testing; 2) 6-weeks post-baseline; and 3) 12-weeks post-baseline. The administered assessments include: 1) Static balance, double limb stance; 2) The Berg Balance Scale (BBS); 3) Timed Up and Go (TUG), 4) Functional Gait Assessment (FGA); and 5) Walking task.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with idiopathic Parkinson' disease
排除标准
- •A pre-screening questionnaire will assess the following:
- •peripheral neuropathy, vestibular concerns, cognitive impairment, severe arthritic conditions, or other conflicting medical conditions
- •deep brain stimulation
- •currently wearing orthotics, or previously worn in the last two years
- •decreased plantar sole sensation
- •requires the ability to walk 10m unassisted
结局指标
主要结局
Change in Postural Sway during Static Stance
时间窗: 6 weeks and 12 weeks post-baseline
Static balance will be measured by the amount of postural sway in both the medio-lateral (ML) and antero-posterior (AP) directions. Participants will be asked to stand, without movement, on the pressure platform for 2 minutes. The force platform will measure the amount of spatio-temporal firing patterns from the sensory afferents in the plantar surface of participant's feet. Secondly, the IRED markers placed on participants clothing, will measure the center of mass (COM) changes in relation to the base of support (BOS). An improvement in the location of the COM in relation to the BOS suggests an improvement in balance, resulting from increased cutaneous sensation from the textured material.
Change in Dynamic Balance, using the Berg Balance Scale, Timed Up and Go, and the Functional Gait Assessment
时间窗: 6 weeks and 12 weeks post-baseline
Improvements in dynamic balance and postural stability will be defined by score improvements on the BBS, TUG, and FGA assessments. Furthermore, plantar pressure changes will be recorded during the walking task to determine if simple changes in top cover design can alter the cutaneous information from the plantar surface of the foot. Observations will be made of the plantar pressure distribution changes between the orthotic, with and without a textured top cover, in comparison to participants walking patterns with footwear alone.
次要结局
- Change in Plantar Pressure Distribution(6 weeks and 12 weeks post-baseline)
- Change in Stride Width(6 weeks and 12 weeks post-baseline)
- Change in Single Limb Support Time(6 weeks and 12 weeks post-baseline)
- Change in Walking Velocity(6 weeks and 12 weeks post-baseline)
- Change in Stride Length(6 weeks and 12 weeks post-baseline)
- Change in Electromyography (EMG) Activity(6 weeks and 12 weeks post-baseline)
研究者
Kelly Robb
master's student
Wilfrid Laurier University