Prosthetic Performance Enhancement Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Session adherence
研究概览
简要总结
The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.
详细描述
Despite advances in the technology for artificial limbs (prostheses), falling and the fear of falling continue to be barriers to mobility for many lower limb prosthesis users after their initial rehabilitation. The loss of ability and confidence in pursuing everyday tasks negatively impacts quality of life, and ongoing physical and mental health. This study will test and improve a rehabilitation training intervention involving walking on uneven ground to improve walking skill and confidence in lower limb prosthesis users.
Lower limb prosthesis users will be recruited. Participants will be allocated randomly to receive either intervention A: training on a flat surface, or intervention B: training on an uneven surface. Depending on their ability and confidence, participants will complete the walking practice either on a treadmill or on a mat with an identical surface pattern. The walking practice will take place three times per week for four weeks. As each participant improves their ability, training tasks will be made more difficult by limiting handrail use, by increasing walking speed, and, for intervention B, also by making the walking surface more uneven.
The objectives of this pilot study are to evaluate adherence and refine the training protocols in preparation for a definitive trial that will inform rehabilitation practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lower limb amputation at ankle (Symes) level and above
- •age 18+ years
- •fitted with a walking prosthesis and use it regularly for home and/or community ambulation
- •good socket fit, assessed by a score of 8-10 on the socket fit comfort scale
- •able to walk for three minutes at a time with or without an assistive device
排除标准
- •leg/foot ulcer or other conditions that cause pain during weight-bearing
- •poor skin integrity that could cause tissue breakdown by walking
- •cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity
- •unilateral or bilateral upper limb absence or loss at the wrist and above that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use.
- •pregnancy
研究组 & 干预措施
Flat terrain training
Walking on a standard, flat treadmill or mat.
干预措施: Flat terrain locomotor training (Other)
Uneven terrain training
Walking on an uneven terrain treadmill or mat.
干预措施: Uneven terrain locomotor training (Other)
结局指标
主要结局
Session adherence
时间窗: Through study completion, over 4 weeks
Percentage of planned sessions attended, per participant.
次要结局
- L-test time(Pre-intervention, within 5 days post intervention)
- Activities-specific Balance Confidence Scale summary score(Pre-intervention, within 5 days post intervention)
- Average daily activity(Pre-intervention, within 5 days post intervention)
- Four Square Step Test time(Pre-intervention, within 5 days post intervention)
- Single leg stand time(Pre-intervention, within 5 days post intervention)
- Two-minute walk test distance(Pre-intervention, within 5 days post intervention)
- Protocol acceptability(End of intervention week 4)
- Recruitment feasibility - recruitment rate(From start of recruitment period, to 12 month time point.)
- Recruitment feasibility - participating clinics(Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.)
- Recruitment feasibility - sample characteristics(Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.)
- Activity data evaluation(Throughout activity monitoring period, over 2 weeks)
- Maximum relative variability of lateral trunk velocity during uneven terrain in comparison to overground walking(Through study completion, over 4 weeks)
- Contour depth at maximum relative variability(Through study completion, over 4 weeks)
- Maximum relative step width variability during uneven terrain in comparison to overground walking(Through study completion, over 4 weeks)
- Prosthesis Users Survey of Mobility t-score(Pre-intervention, within 5 days post intervention)