Impact of Therapeutic Footwear and Plantar Orthoses on Diabetic Neuropathic Foot in Quality of Life and Functionality
- Conditions
- Diabetic Peripheral NeuropathyDiabetes Mellitus, Type 2
- Interventions
- Device: Standard FootwearDevice: Orthopedic FootwearDevice: Plantar OrthosesBehavioral: Education on foot self-care
- Registration Number
- NCT04605900
- Lead Sponsor
- Universidade do Algarve
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Footwear (SF) Education on foot self-care Intervention: plantar orthoses, education on foot self-care and appropriate standard footwear. Orthopedic Footwear (OF) Plantar Orthoses Intervention: plantar orthoses, education on foot self-care and orthopedic footwear. Standard Footwear (SF) Standard Footwear Intervention: plantar orthoses, education on foot self-care and appropriate standard footwear. Standard Footwear (SF) Plantar Orthoses Intervention: plantar orthoses, education on foot self-care and appropriate standard footwear. Orthopedic Footwear (OF) Education on foot self-care Intervention: plantar orthoses, education on foot self-care and orthopedic footwear. Orthopedic Footwear (OF) Orthopedic Footwear Intervention: plantar orthoses, education on foot self-care and orthopedic footwear.
- Primary Outcome Measures
Name Time Method Change the Performance of Lower Extremity Functional Scale 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 4 months Significantly change the maximum distance (cm) attained in Functional Reach Test.
Change the 6 minutes walk test performance 4 months Change the distance (m) covered for 6 minutes of walking.
Change the Unipedal Stance Test performance 4 months Change the time (s) in left and right unipedal stance.
Change the Static Full Tandem Test performance 4 months Change the time (s) in full-tandem position.
Change the Time Up and Go Test performance 4 months Change the time (s) in performing the Time Up and Go test.
Change the Walking Full Tandem Test performance 4 months Achieve at least 10 steps in full-tandem.
Change the Quality of Life 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.
- Secondary Outcome Measures
Name Time Method Change the maximum pressure in static position 4 months Change the maximum pressure (kPa) in each forefoot and hindfoot in static position.
Change the Postural Stability (length displacement of Center of Pressure) 4 months Significantly change the length displacement (mm) of center of pressure.
Change the Postural Stability (Romberg Ration Index) 4 months Significantly change the romberg ration index (mm).
Change the support surface in static position 4 months Change the support surface (cm2) between the plantar surface and the platform sensors, during the support phase on each of the feet.
Change the Postural Stability (displacement of Center of Pressure) 4 months Significantly change the amplitude mediolateral and anteroposterior displacement (mm) of Center of Pressure.
Change the Postural Stability (Mean Speed of Center of Pressure) 4 months Significantly change the mean speed of CoP (mm/s).
Change the Postural Stability (Root Mean Square) 4 months Significantly change the root mean square index (mm).
Change the mean pressure in gait 4 months Change the mean pressure (kPa) on each foot in gait.
Change the Postural Stability (Ellipse surface) 4 months Significantly change the ellipse surface (mm2).
Change the Postural Stability (Standard deviation of Center of Pressure) 4 months Significantly change the mediolateral and anteroposterior standard deviation (mm).
Change the mean pressure in static position 4 months Change the mean pressure (kPa) on each foot in static position.
Change the maximum pressure in gait 4 months Change the maximum pressure (kPa) of each foot in gait.
Change the load distribution in static position 4 months Change the load distribution (%) between each foot.
Change the foot progression angle of gait 4 months Change the foot progression angle in gait.
Adherence to the intervention 2 months Number of hours per day using the devices (telephone monitoring).
Self-Perception of improvements 2 months Presence or not of improvements in feet/legs with the devices (telephone monitoring).
Satisfaction with devices 2 months Level of Satisfaction (totally satisfied, quite satisfied, satisfied, little satisfied, dissatisfied) with the devices (telephone monitoring).
Change the plantar impression length in gait 4 months Change the plantar impression Length (mm) of each of the feet.
Change the longitude of CoP in gait 4 months Change the longitude of the center of pressure (mm) of each foot.
Change the support surface in gait 4 months Change the support surface (cm2) of each foot.
Change the load distribution in gait 4 months Change the load distribution (%) between the forefoot and hindfoot and between the medial and lateral zone.
Change the double support time of gait 4 months Change the double support time (ms) in gait.
Change the step length of gait 4 months Change the step length (m) in gait.
Change the support time of gait 4 months Change the support time (ms) for each foot in gait.
Trial Locations
- Locations (1)
Marta Botelho
🇵🇹Faro, Algarve, Portugal