跳至主要内容
临床试验/NCT01740635
NCT01740635已完成不适用

Enhancing Participation In the Community by Improving Wheelchair Skills (EPIC WheelS): A Feasibility Study

University of British Columbia4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年3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
20
试验地点
4
主要终点
Wheelchair Skills Test (WST) - Capacity

研究概览

简要总结

Many older adults have difficulty walking. A wheelchair can improve their participation but older adults typically receive little wheelchair training. Structured training programs are effective but rely on multiple 1:1 sessions with a skilled clinician. EPIC WheelS combines 2 brief training sessions and a 4-week home training program delivered using a portable computer tablet and monitored by an expert trainer. This study investigates the feasibility and potential for using EPIC WheelS with older adult novice wheelchair users in Vancouver and Winnipeg, measuring the impact on wheelchair skill, safety and confidence compared to a control group receiving only cognitive training.

Hypotheses: The investigators expect that the feasibility outcomes will be sufficiently robust to support conducting a subsequent multi-site RCT. The investigators also expect the EPIC WheelS training program will have a significant treatment effect with improvement in wheelchair mobility, compared to a control group.

详细描述

Many older adults rely on a manual wheelchair (MWC) for community mobility, but are not provided with the skills for independent and effective use of their wheelchair. Suboptimal use of the wheelchair results in substantial social costs such as reduced engagement in meaningful activity, social isolation, and higher caregiver burden. This is a poor use of financial resources, including the cost of wheelchair acquisition and requirements for attendant care. Access to skills training is constrained by the expense and limited availability of skilled therapists; demands of patient and/or clinician travel; and lack of training programs designed specifically for older adults.

Enhancing Participation In the Community by improving Wheelchair Skills (EPIC WheelS) is an individualized home-training program that optimizes learning for older adults while limiting the time demands of expert trainers. Using an affordable mainstream computer tablet device, EPIC WheelS provides a structured training program that can be customized for specific users needs. The tablet is mobile, for in-chair or tabletop use, in home and community locations. A touch screen operated audio-visual display features interactive training and practice activities as well as video-recording capability. Wireless Internet enables user-trainer communication and remote program monitoring and updating by the trainer. A monitored home program that is effective and efficient for older adults has the potential for application to other target groups, particularly those in rural and remote locations with limited access to rehabilitation.

PURPOSE: The purpose is to evaluate the feasibility and effect size estimate of a 1-month customized home training program (EPIC WheelS) for improving wheelchair mobility skills among novice older adult manual wheelchair users compared to usual care. Despite the pervasive use of wheelchairs as an intervention in rehabilitation, the evidence for training in effective wheelchair use is still underdeveloped. Structured training has demonstrated excellent potential, but the most effective and efficient means of providing that training remains unclear. Larger multi-site clinical trials are required to establish evidence to inform and direct clinical practice. The investigators propose that this 2-year feasibility trial is not only critical, but also prudent, prior to moving forward with an expensive large multi-site randomized controlled trial (RCT). Specifically the results of this study will address 1) feasibility outcomes (i.e., recruitment and retention; trainer and subject burden; safety; intervention administration and adherence; perceived benefit) and 2) clinical outcomes (i.e., effect size calculations for the primary and secondary measures). Although the principal intent is feasibility, the sample size calculation is based on the primary clinical outcome to provide a reasonable estimate of an effect size for planning the subsequent large scale RCT.

HYPOTHESES: The investigators expect that the feasibility outcomes will be sufficiently robust to support conducting a subsequent multi-site RCT. The investigators also expect the EPIC WheelS training program will have a significant treatment effect with improvement in wheelchair mobility, compared to a control group. The primary clinical endpoint will be wheelchair skill capacity, as measured by the Wheelchair Skills Test (WST). Secondary clinical outcomes will include wheelchair skill safety; confidence with wheelchair use; mobility; and user evaluation of performance in participation-oriented activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Wheelchair users must
  • be at least 50 years old
  • use his/her wheelchair for at least 1 hour per day on average
  • live within the metropolitan boundaries of Vancouver or Winnipeg
  • have a caregiver who is able to attend training sessions and supervise home training
  • Caregivers must
  • be 19 years old or older
  • be a caregiver of a manual wheelchair user who is 50 years or older
  • able to attend the training sessions
  • be able to supervise or spot the wheelchair user during home training

排除标准

  • Wheelchair users would be excluded if he/she
  • cannot communicate or complete the study questionnaires in English
  • has a health condition or upcoming procedure that would prevent you from performing training activities (e.g., cancer treatment, surgery)
  • is currently receiving wheelchair skills training elsewhere
  • cannot use both arms to propel your wheelchair
  • Caregivers will be excluded if
  • he/she cannot communicate in English
  • he/she has a health condition or upcoming procedure that would prevent you from supervising training activities (e.g., cancer treatment, surgery)

研究组 & 干预措施

EPIC WheelS Training Program

Experimental

The EPIC WheelS program includes a comprehensive, structured library of educational material and training activities, organized in a hierarchy from simple to complex. Experimental group subjects will attend 2 training sessions with an expert Trainer. The Trainer will individualize a structured home training program, delivered via a computer tablet, and subjects will train at home for 1 month.

干预措施: EPIC WheelS Training Program (Device)

Cognitive games

No Intervention

To provide a comparable level of investigator attention, control group subjects will receive two 1-hour social visits. To control for Trainer bias, the experimental and control groups will have separate Trainers. During social visits, the Trainer will discuss subjects' current community activities and their experience using the wheelchair, and provide verbal information related to barriers encountered. Subjects will receive a computer tablet with cognitive stimulation games to account for activity and tablet device exposure. Participants in the extra wheeling sub-group will be instructed to perform additional, unstructured wheeling for 15 minutes, 5 days per week (total 75 minutes/week) and document these on a simple calendar-style form provided. To minimize attrition, control subjects will receive a DVD with a condensed MWC skills education program after the post-intervention data collection is complete.

结局指标

主要结局

Wheelchair Skills Test (WST) - Capacity

时间窗: 4 weeks

Wheelchair mobility skill capacity will be measured using the Wheelchair Skills Test 4.1 (WST). The WST is a structured assessment with 32 discrete mobility skills required to perform social roles in the community, each scored dichotomously as pass/fail. The WST produces a total Skill Capacity score (0-100%) reflecting the number of skills safely passed. To optimize stability of the measure, increase precision, and control for a learning effect, the WST will be administered twice at baseline and a mean baseline score calculated. Standardized equipment required for the WST (e.g., 5 degree \& 10 degree ramps, gravel) is available at both test sites.

次要结局

  • Wheelchair Outcome Measure (WhOM)(Baseline, 4 weeks)
  • Wheelchair Use Confidence Scale for Manual Wheelchair Users (WheelCon-M 3.0)(Baseline, 4 weeks)
  • No adverse events reported(Baseline, 4 weeks)
  • Wheeling While Talking test(Baseline, 4 weeks)
  • Wheelchair Skills Test (WST) - Safety(Baseline, 4 weeks)
  • Health Utility Index 3(Baseline, 4 weeks)
  • Wheeling While Talking Test(Baseline, 4 weeks)
  • Participant retention rate of 80%(Baseline, 4 weeks)
  • Life-Space Assessment (LSA)(Baseline, 4 weeks)
  • Training adherence (150 minutes/week) rate of 85%(Baseline, 4 weeks)
  • Data logger(Baseline, 4 weeks)

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 (4)

Loading locations...

相似试验