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临床试验/NCT01131819
NCT01131819已完成不适用

Use of an Interactive Video Game as Part of a New Amputee Rehabilitation Program

University of British Columbia2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2010年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Short Physical Performance Battery

研究概览

简要总结

Purpose: The investigators wish to determine if a rehabilitation program for subjects with new, trans-tibial amputations that has the balance portion of the program augmented by the use of the Nintendo Wii fit ™ balance board improves their performance.

Hypothesis: The investigators hypothesize that subjects will benefit from the use of the device and that this will manifest as an improvement on outcome measures.

详细描述

All subjects will be trained by the same specialist physiotherapist. Subjects will use the Wii Fit balance platform for a period of twenty minutes or greater per day (at the discretion of the specialist physiotherapist) during their standard rehabilitation program. These balance training exercises will be in addition to those already used in the standard rehabilitation program, but will not add to the total therapy session time. Activities on the device will be chosen by the therapist based on the subjects' current abilities and their phase of training. More complicated tasks will be given as the subject progresses. The therapist will intervene and provide instruction / correction if the subject is using unsafe technique or poor technique (postures, positioning strategies that would not be condoned in the regular training program).

The device is a stable, level platform 5.5 cm from the floor. Subjects stand on the device and may use gait aids if indicated.

Standard practice involves intensive training of the subject by the same specialist physiotherapist but without the use of the Wii Fit platform.

研究设计

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

入排标准

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

入选标准

  • Consented subjects with new, unilateral, transtibial amputations who are greater than 19 years of age

排除标准

  • Subjects who have an open wound that limits their wearing of the prosthesis

研究组 & 干预措施

1

Other

The novel intervention we propose to use, the Wii Fit, will be introduced for a period of at least 20 minutes but not greater than 30 minutes per day to all the subjects in the study.

干预措施: Nintendo Wii fit ™ balance board (Device)

结局指标

主要结局

Short Physical Performance Battery

The Short Physical Performance Battery (SPPB) measures subject's ability to perform three tasks: standing balance, gait speed and lower extremity strength (chair stands). Collected at each data collection session

NeuroCom Clinical Research System

The NeuroCom Clinical Research System is a commercially available objective measure that is able to detect and document perturbations in balance in three (X, Y, Z components) planes in order to determine postural sway. The system consists of a dual platform that moves or does not move in conjunction with a visual surround. The Sensory Organization Test (SOT) will be used to test 3 sensory components of balance (visual, somatosensory and vestibular inputs) under 6 standard conditions. Collected at each data collection session.

次要结局

  • Balance confidence will be measured using the 16 item Activities-specific Balance Confidence (ABC Scale). The items assess the perceived confidence (self-efficacy) the individual has in performing an increasing complex series of tasks.
  • The Short Feedback Questionnaire-modified (SFQ-M) will be used to determine subjects' level of satisfaction with their rehabilitation program as well as with the interactive video game experience.
  • Walking endurance will be assessed using the 2 Minute Walk Test (2MWT). Starting from a standing position this test requires individuals to walk at a fast safe pace for a period of two minutes.
  • Walking ability will be measured using the L-Test. This walk test incorporates a sit-to-stand component, turns to both the left and the right over a distance of 20 meters.
  • A 9-item Falls Diary will be kept by each subject documenting number of falls, circumstances (eg/ cause, location, assistive device used or not) and consequences (eg/ medical visit, injury) over the past week.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William C. Miller

Principal Investigator

University of British Columbia

研究点 (2)

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