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临床试验/NCT03989063
NCT03989063Unknown不适用

Motor Learning in Individuals With Lower Limb Loss and Chronic Diabetes

University of Nevada, Las Vegas2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
55
试验地点
2
主要终点
Change in balance performance

研究概览

简要总结

Inadequate rehabilitation training after amputation can result in poor patient outcomes, injuries, and wasted healthcare resources. This is a serious public health problem due to an aging population and rising prevalence of diabetes (main cause of amputation in the U.S.). In this study, the investigators will examine the effects of external vs. internal attentional focus instruction on learning of a balance task in individuals with existing amputation and those at risk of amputation (older adults with diabetes). With the proposed research, the investigators aim to expand the understanding of motor learning in individuals with and at risk of lower limb loss to provide knowledge that will lead to more effective and efficient rehabilitation.

详细描述

  1. Prior to participation in the study, the purpose and procedures of the study, including possible image and video recordings, will be explained to the subjects.
  2. Subjects will then be required to give written consent for their participation and will receive a copy of their consent form.
  3. The following 2-part research protocol uses a similar experimental protocol (learning a balance task) on individuals with leg amputation (Part 1), and individuals with chronic diabetes (Part 2).

Part 1:

The experiment will take place over a 3-day period including screening and baseline testing (Visit 1), balance training (Visits 2), and retention testing (Visit 3; at least 24 hours after Visit 2). On Visit 1, the investigators will assess aspects of health and functional capacity to assess participation eligibility and establish baseline characteristics of the participants. In addition to medical history and anthropometric measurements, the assessment will consist of clinical surveys of quality of life, physical activity level, balance confidence, and fear of falling. Ambulatory performance will be quantified. Additional amputee-specific measures will be used to assess functional characteristics unique to the population.

The balance training involves standing and maintaining balance on a stabilometer, which consists of a platform (1.3m long by 1.4m wide) connected to a single axis that allows bi-directional sway (Lafayette Instrument Co.; Figure 1). The maximum angular deviation of the platform is 18°. A safety harness is provided to prevent falls but does not provide support during the performance of the task. The load on the harness will be monitored with an S-type strain gauge (Delsys Inc., Massachusetts, USA) connected in series to the harness tether. Participants are required to maintain balance with feet in a medial-lateral orientation while standing on the balance board and looking straight ahead. A potentiometer monitors the sway angle of the platform. An integrated timer measures time in balance, which is defined as when the platform angle is within ± 5° of horizontal.[52] The primary outcome measure is time in balance (sec.) for each 30s trial. The secondary outcome measure is platform angular deviation from horizontal (RMSE; degree).

Participants will be assigned to receive the 2 attentional focus conditions in random order. Depending on the condition, participants will receive either internal or the external focus instruction on where to direct their attention while training to perform the balance task. During training, the assigned instruction will be reinforced at the beginning and after every 5 practice trials. After they complete training with the first condition, they will go through a washout period (at least 4 weeks) before receiving training under the other condition. Participants will be blinded to the purpose of the intervention and study design until debriefing at the end of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participants are randomly assigned to one of the two parallel groups receiving either external or internal attentional focus instructions for the same balance task. Participants will be blinded to this group assignment until final debriefing.

入排标准

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

入选标准

  • 未提供

排除标准

  • Have other concurrent central nervous system diseases that influence motor functions and balance.
  • Have leg/foot ulcer or other conditions that cause pain during weight-bearing.
  • Have cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity.

结局指标

主要结局

Change in balance performance

时间窗: Throughout the balance training period (2 days, up to 40 trials) and during the post-training tests

During each balance practice trial, average deviation of balance platform angle from horizontal will be measured in degrees. Smaller deviation from horizontal indicates better balance performance.

次要结局

  • Change in patient's self-reported outcomes(Throughout the balance training period (2 days, assessed every 5 practice trials).)
  • Change in fall recovery performance(Before and after the 2-day balance training. The after training assessment will be conducted 2-10 days after the conclusion of the balance training.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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