PhD Research Project: Clinimetric Properties of Outcome Measures of Physical Function Used With Lower Limb Amputees, Study 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The changes in scores in all tests during early rehabilitation period.
研究概览
简要总结
During any period of rehabilitation it is important to select meaningful tests that; measure what you want, are responsive to changes in the patient's condition and, easy to use in the clinical settings. With an amputee such tests may help make sure that rehabilitation programmes and the prosthesis (artificial leg) provided are tailored for the individual. New prosthetic technology is continually being developed and the active amputee now demands more from their artificial limbs. Making sure that they get the right rehabilitation programmes and the most appropriate prosthesis will help them perform to their best.
Thirty amputees who have recently undergone a lower limb amputation will be recruited into this study. They will be asked to complete 2 walking tests and 4 questionnaires that measure different aspects of their recovery from the comfort of the socket to their perceived ability to undertake everyday tasks. Each of the tests give a score or grade which represents the level of their ability, as judged by the test, at that given time point. The tests will be repeated at one and three weeks after delivery of their prosthesis, just before discharge from hospital and at 6 weeks post-discharge.
By measuring the changes in the scores across these time points, and also how the amputees feel they have changed, it is hoped that it can be determined how responsive the tests are to objective measures of changes in the amputees abilities and also whether the tests are sensitive to the changes felt by the amputee. If it is shown we can more accurately link changes in the scores to the changes in the amputees abilities then Physiotherapy treatment programmes could be more accurately tailored to the individual amputee.
详细描述
The Outcome Measures (tests) to be used in this study were identified from a survey of Health Professionals across the UK. The top 5 in use were:
SIGAM Mobility Grades The Special Interest Group in Amputee Medicine (SIGAM) Mobility Grades describe a single-item scale comprising of six clinical grades (A -F) of amputee mobility. A self-reported questionnaire has 21 yes/no items and when the answers are applied to an algorithm a final clinical grade is assigned.
Timed up and go (TUAG) The TUAG test is a standardised quantitative measure of most of the manoeuvres required for 'basic mobility'. The subject is timed as they stand up from a chair, walk 3m, turn and return to the chair. The score is simply the time taken to complete the circuit.
Timed Walk Test A walk test is often used to measure functional exercise capacity. Participants are instructed to walk from end to end of an enclosed quiet corridor, covering as much ground as possible in the allotted time period. The primary outcome of interest is distance walked, but velocity can also be calculated.
Locomotor Capability Index, basic (LCI) and advanced (LCI-5) The Locomotor Capability Index (LCI) is a self-administered scale specifically designed for use with lower limb amputees. It has 14 questions about locomotor activities. The answers required are either yes or no to questions phrased such as: "Would you say you are able to do the following activities with your prosthesis on?" The LCI can be sub-divided into 2 subscales: basic and advanced. The total scores from each activity are totaled for a possible maximum score of 42 (basic) and 56 (advanced).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single lower limb amputees, at either trans-tibial (below-knee) or trans-femoral (above-knee) level 18 years or older Taking delivery of their first prosthesis (artificial limb)
排除标准
- •Limb-fitting for transfer activities only Co-morbidities that may prevent the amputee undertaking any of the physical activities involved in the OMs, such as: severe heart disease, respiratory disease or arthritis Poor cognition, as identified by the patient's clinical team, which may prevent the patient from fully understanding the written questionnaires
研究组 & 干预措施
Post-amputation functional rehab
Patients will continue with their rehabilitation programme, as specified by their clinical team, following amputation. A series of functional outcome measures will be carried out at 3 or 4 time points during the first 3 months following delivery of their artificial limb.
干预措施: Post-amputation functional rehabilitation (normal clinical practice) (Other)
结局指标
主要结局
The changes in scores in all tests during early rehabilitation period.
时间窗: 2 weeks and 6 weeks
The changes in scores in all Outcome Measures during Time Period 1 and Time Period 3 will be recorded. For each Outcome Measure during each time interval the effect size (ES)will be calculated, using the formula below. These will serve as a statistical description of the sensitivity to change or responsiveness of each Outcome Measure. ES = mean diff (SV1-SV2) / (SD SV1-SV2) A higher ES value indicates higher responsiveness.
次要结局
- Mean scores and the score changes recorded in the two time periods under investigation, i.e. T1 and T3 will be compared within the different categories in the Activity Change Questionnaire.(2 weeks and 6 weeks)
研究者
Judy Scopes
PhD Student
Queen Margaret University