10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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10 Years Follow-up of Gait Characteristics, Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes

Conditions
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Diabetes, Diabetic Foot, Plantar Ulcer, Neuropathy, Gait Disorder, Sensorimotor, Motor Neuropathy, Foot Deformities, Foot Ulcer

Intervention / Treatment
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* Device: Prefabricated insoles
* Device: Soft custom-made insoles
* Device: Hard custom-made insoles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intervention groups: To be a participant in the original RCT To be aged 18 years or more To walk without walking aid To understand the Swedish language No presence of foot ulcer Exclusion Criteria: Presence of foot ulcers Control group To be first-time visitors to the DPO To be aged 18 years or more To walk without walking aid To understand the Swedish language No presence of foot ulcer Exclusion Criteria: Presence of foot ulcers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a 10 year follow-up of an original randomized clinical trial (RCT) study (n= 114 patients) with type 1 and type 2 diabetes. The participants were referred to the department of Prosthetics & Orthotics (DPO) at Sahlgrenska University Hospital and were randomised to: 1) use prefabricated insoles, 2) soft custom-made insoles or 3) hard custom-made insoles. The groups were followed 2 years with follow-ups every 6 months. Data regarding plantar pressure, gait characteristics, kinetics and kinematics and presence of risk factors will be collected 10 years after inclusions. Comparisons will be made with a group of patients with diabetes being first times visitors to the Department of Prosthetics & Orthotics.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prefabricated insoles<br>Prefabricated insoles with support in medial arch and metatarsal pad. A 2 mm top layer of cushioned material. | Device: Prefabricated insoles<br>* The participants received prefabricated insoles<br>|
| Experimental: Custom-made insoles soft<br>Custom-made insoles formed over an individual cast positive. 35 shore of hardness in material Ethyl Vinyl Acetate. | Device: Soft custom-made insoles<br>* The participants received soft custom-made insoles<br>|
| Experimental: Custom-made hard<br>Custom-made insoles formed over an individual cast positive. 55 shore of hardness in material Ethyl Vinyl Acetate. | Device: Hard custom-made insoles<br>* The participants received hard custom-made insoles<br>|
| No Intervention: Control group<br>No intervention with therapeutic insoles and/or shoes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak pressure | To compare the differences of peak pressure (kPa) in the four groups. | 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. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moment at ankle-knee-and hip joint | To compare the differences of joint moment (Nm/kg) in the four groups. | through study completion, an average of 1 year | 
| Speed | To compare the differences of speed (m/s) in the four groups. | through study completion, an average of 1 year | 
| Cadence | To compare the differences of cadence (step/min) in the four groups. | through study completion, an average of 1 year | 
| Stance (percent of stand phase) | To compare the differences of stance phase (%) in the four groups. | 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 | 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 | 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 | 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) | 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) | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orthotics, kinematics, kinetics