跳至主要内容
临床试验/NCT06284525
NCT06284525已完成早期 1 期

Ankle Assistance and Resistance in Older Adults

Northern Arizona University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
9
试验地点
2
主要终点
Change in 6MWT

研究概览

简要总结

The goal of this research protocol is to improve mobility in older individuals through advances in wearable assistive devices by focusing on two specific aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals.

详细描述

The overarching goal of this study is to improve mobility in older adults through advances in wearable assistance (i.e. powered orthoses). This goal will be accomplished by focusing on two specific research aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals.

Several powered orthosis conditions will be tested during several modes of walking or running and balance throughout the course of the study. Trials will take place over-ground and/or on a treadmill. Balance trials will take place on a treadmill. Participants will walk for up to 40 minutes. Frequent breaks will be provided between trials and conditions to avoid fatigue; a maximum of 15 minutes of continuous walking will take place between breaks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 65 and 85 years old, inclusive.
  • Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
  • Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
  • The ability to read and understand English.
  • Able to walk at least 30 feet with or without a walking aid
  • Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking

排除标准

  • Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis that would affect the ability to walk as directed for short periods of time. Note: For elderly participants, a history of joint replacement or joint degeneration that does not impair their ability to walk safely is allowable.
  • Participant or parent report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.

结局指标

主要结局

Change in 6MWT

时间窗: Baseline assessment and 1-week post training assessment (at 5 weeks)

Change (post - baseline) in six minute walk test distance (distance in meters)

Change in Metabolic Power

时间窗: Baseline assessment and 1-week post training assessment (at 5 weeks)

Change (post - baseline) in metabolic power measured in J/(kgm)

Change in Plantar Flexor Force Production

时间窗: Baseline assessment and 1-week post training assessment (at 5 weeks)

Change (post - baseline) in manual muscle testing plantar flexor force production measured in N/kg

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验