A combination of diabetes and neuropathy can cause an altered gait, increased tissue stiffness, limited joint mobility, muscle weakness, foot deformities, thus leading to excessive plantar pressure. The presence of an increased plantar pressure and the loss of sensation is a serious risk factor in the risk of development of diabetic foot ulcers (DFU). Therefore, appropriate shoes and insoles are recommended to redistribute high peak pressure (PP) and reduce pressure time integral (PTI) . Shoe modifications and insoles, when used, is effective to prevent the recurrence of plantar ulcer. The primary aim of the study was to: explore gait characteristics, kinetics and kinematics in a cohort of patients diagnosed with diabetes, with and without neuropathy, assigned to use different types of insoles. The second aim was to assess the relation between gait characteristics, kinetics and kinematics to high plantar PP and PTI. The third aim was to compare gait characteristics, kinetics and kinematics of patients with diabetes and healthy controls.
A combination of diabetes and neuropathy can cause an altered gait, increased tissue stiffness, limited joint mobility, muscle weakness, foot deformities, thus leading to excessive plantar pressure . The presence of an increased plantar pressure and the loss of sensation is a serious risk factor in the risk of development of diabetic foot ulcers (DFU). Therefore, appropriate shoes and insoles are recommended to redistribute high peak pressure (PP) and reduce pressure time integral (PTI). Shoe modifications and insoles, when used, is effective to prevent the recurrence of plantar ulcer. Patients presenting with mild or absence of neuropathy have lower PP compared to those having more severe stages of neuropathy. However, these findings are not unambiguous. In a study patients walked in a standardize speed of 1.2 m/s, and it was only under the first metatarsal phalangeal joint that the group with neuropathy had higher PP compared to patients with diabetes without neuropathy. In the remaining parts of the foot sole, there was no difference. In a study comparing custom-made insoles and prefabricated insoles used in a walking shoe, a cohort of patients with no history of foot ulcers was studied and there were no differences in PP for the sub groups with and without neuropathy. More knowledge is needed regarding risk factors such as neuropathy, gait deviation and differences in kinematics and kinetics in order to prevent the onset of the "first" plantar ulcer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
224
The participants received prefabricated insoles
The participants received soft custom-made insoles
The participants received hard custom-made insoles
Department of Prostetics & Orthotics
Gothenburg, Region Västragötaland, Sweden
Peak pressure
To compare the differences of peak pressure (kPa) in the four groups.
Time frame: through study completion, an average of 1 year
Pressure time integral
To compare the differences of pressure time integral (kPa\*s) in the four groups.
Time frame: through study completion, an average of 1 year
Moment at ankle-knee-and hip joint
To compare the differences of joint moment (Nm/kg) in the four groups.
Time frame: through study completion, an average of 1 year
Speed
To compare the differences of speed (m/s) in the four groups.
Time frame: through study completion, an average of 1 year
Cadence
To compare the differences of cadence (step/min) in the four groups.
Time frame: through study completion, an average of 1 year
Stance (percent of stand phase)
To compare the differences of stance phase (%) in the four groups.
Time frame: through study completion, an average of 1 year
Range of foot-knee and hip angles (minimum to maximum)
To compare the differences of maximum angle (degree) in the four groups
Time frame: through study completion, an average of 1 year
Walking distance of 5 minutes walking
To compare the differences of 5 minutes walking(m) distance in the four groups
Time frame: through study completion, an average of 1 year
Distribution of risk grade ( the risk to develop diabetic foot ulcers 1-4(1=no risk, 4=presence of foot ulcers)
To assess the distribution of risk grade (1-4) in the four groups
Time frame: through study completion, an average of 1 year
Relation of different types of insoles and risk factors to peak pressure
To assess the influence of different types of insoles and risk factors on high peak pressure (kPa)
Time frame: through study completion, an average of 1 year
Relation of different types of insoles and risk factors to pressure time integral
To assess the influence of different types of insoles and risk factors on pressure time integral (kPa\*s)
Time frame: through study completion, an average of 1 year
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