Impact of Therapeutic Footwear and Plantar Orthoses for Patients With Diabetic Neuropathic Foot in Quality of Life and Functionality: A Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change the Performance of Lower Extremity Functional Scale
研究概览
简要总结
This study determines the effectiveness of plantar orthoses and custom-made orthopedic footwear in functional level and quality of life of persons with diabetes type 2 and diabetic peripheral neuropathy. This study is important due the loss of protective sensation, feet are vulnerable to minor trauma caused by plantar pressure as well as mechanical and thermal injuries. Thus, Plantar Orthoses become necessary to reduce PP and align the foot. Additionally, it is known that footwear is the most frequent cause of diabetic foot injury, since ulceration is frequently a consequence of the continuous trauma provoked by inadequate footwear. For a higher efficacy in the treatment of the foot, it is also necessary to use custom-made orthopedic footwear, indicated in the treatment of foot pathologies.
The lack of studies that evaluate the impact of this treatment on clinical measures such as quality of life and functional level, led to the development of this study, comparing a standard treatment (standard footwear and plantar orthoses) with an optimal treatment suggested in diabetic foot guidelines (therapeutic footwear and plantar orthoses).
详细描述
This clinical trial includes 2 parallel intervention groups with a pre- and post-test analysis. In the standard footwear (SF) group, plantar orthoses, standard footwear and education on foot self-care were applied and in the orthopedic footwear (OF) group the same intervention was applied, but with orthopedic footwear.
Both intervention groups were evaluated at two different time points, with the pre-test taking place at the beginning of the study (T0 - Baseline) and the post-test taking place 4 months after the application of the treatment (T4). In the middle of the study, at two months (T2) a questionnaire was applied in order to understand the adherence and the perception of individuals about the intervention applied.
The screening of diabetic peripheral neuropathy was made with the Michigan Neuropathy Screening Instrument (MNSI) and the description of the sample with an evaluation questionnaire.
The FL was evaluated through the Lower Extremity Functional Scale (LEFS), physical tests and the postural, static and dynamic barometric assessment. QoL was assessed with SF-36 and the adherence and satisfaction with a questionnaire created ad hoc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of type 2 DM;
- •Have at least 6 months from diagnosis of DM;
- •Presence of Diabetic Polyneuropathy;
- •No history of plantar orthoses and orthopedic footwear use.
排除标准
- •Active ulceration;
- •Severe osteoarticular deformities;
- •Presence of cognitive impairment;
- •Gait with technical devices;
- •Diagnosis of neurological pathology that can affect the gait pattern;
- •Diagnosis of another pathology that can negatively influence the study: depression, the presence of uncontrolled cardiovascular diseases and active cancer.
- •Surgical interventions on the spine and lower limbs, with less than 1 year of recovery.
结局指标
主要结局
Change the Performance of Lower Extremity Functional Scale
时间窗: 4 months
Change at least 9 points in Lower Extremity Functional Scale (minimum change for clinically relevant functional improvement). Instrument scores can range between 0 - 80. Higher values mean better functionality.
Change the Functional Reach Test performance
时间窗: 4 months
Significantly change the maximum distance (cm) attained in Functional Reach Test.
Change the 6 minutes walk test performance
时间窗: 4 months
Change the distance (m) covered for 6 minutes of walking.
Change the Unipedal Stance Test performance
时间窗: 4 months
Change the time (s) in left and right unipedal stance.
Change the Static Full Tandem Test performance
时间窗: 4 months
Change the time (s) in full-tandem position.
Change the Time Up and Go Test performance
时间窗: 4 months
Change the time (s) in performing the Time Up and Go test.
Change the Walking Full Tandem Test performance
时间窗: 4 months
Achieve at least 10 steps in full-tandem.
Change the Quality of Life
时间窗: 4 months
Significantly change any subscore or total score of Medical Outcomes Study 36-item Short-Form Health Survey instrument, that was use it to assess quality of life. Instrument scores can range between 0 - 100. Higher values mean better self-perception of quality of life.
次要结局
- Change the maximum pressure in static position(4 months)
- Change the Postural Stability (length displacement of Center of Pressure)(4 months)
- Change the Postural Stability (Romberg Ration Index)(4 months)
- Change the support surface in static position(4 months)
- Change the Postural Stability (displacement of Center of Pressure)(4 months)
- Change the Postural Stability (Mean Speed of Center of Pressure)(4 months)
- Change the Postural Stability (Root Mean Square)(4 months)
- Change the mean pressure in gait(4 months)
- Change the Postural Stability (Ellipse surface)(4 months)
- Change the Postural Stability (Standard deviation of Center of Pressure)(4 months)
- Change the mean pressure in static position(4 months)
- Change the maximum pressure in gait(4 months)
- Change the load distribution in static position(4 months)
- Change the foot progression angle of gait(4 months)
- Adherence to the intervention(2 months)
- Self-Perception of improvements(2 months)
- Satisfaction with devices(2 months)
- Change the plantar impression length in gait(4 months)
- Change the longitude of CoP in gait(4 months)
- Change the support surface in gait(4 months)
- Change the load distribution in gait(4 months)
- Change the double support time of gait(4 months)
- Change the step length of gait(4 months)
- Change the support time of gait(4 months)
研究者
Marta Botelho
Research Fellowship
Universidade do Algarve