Diabetes, Diabetic Foot, Foot Deformities, Foot Ulcer, Gait Disorder, Sensorimotor, Motor Neuropathy, Neuropathy, Plantar Ulcer
Conditions
Keywords
orthotics, kinematics, kinetics
Brief summary
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
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.
Interventions
DEVICEPrefabricated insoles
The participants received prefabricated insoles
DEVICESoft custom-made insoles
The participants received soft custom-made insoles
DEVICEHard custom-made insoles
The participants received hard custom-made insoles
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure time integral | through study completion, an average of 1 year | To compare the differences of pressure time integral (kPa\*s) in the four groups. |
| Peak pressure | through study completion, an average of 1 year | To compare the differences of peak pressure (kPa) in the four groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stance (percent of stand phase) | through study completion, an average of 1 year | To compare the differences of stance phase (%) in the four groups. |
| Moment at ankle-knee-and hip joint | through study completion, an average of 1 year | To compare the differences of joint moment (Nm/kg) in the four groups. |
| Speed | through study completion, an average of 1 year | To compare the differences of speed (m/s) in the four groups. |
| Walking distance of 5 minutes walking | through study completion, an average of 1 year | To compare the differences of 5 minutes walking(m) distance in the four groups |
| Distribution of risk grade ( the risk to develop diabetic foot ulcers 1-4(1=no risk, 4=presence of foot ulcers) | through study completion, an average of 1 year | To assess the distribution of risk grade (1-4) in the four groups |
| Relation of different types of insoles and risk factors to peak pressure | through study completion, an average of 1 year | To assess the influence of different types of insoles and risk factors on high peak pressure (kPa) |
| Relation of different types of insoles and risk factors to pressure time integral | through study completion, an average of 1 year | To assess the influence of different types of insoles and risk factors on pressure time integral (kPa\*s) |
| Range of foot-knee and hip angles (minimum to maximum) | through study completion, an average of 1 year | To compare the differences of maximum angle (degree) in the four groups |
| Cadence | through study completion, an average of 1 year | To compare the differences of cadence (step/min) in the four groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health related quality of life | through study completion, an average of 1 year | To assess the quality of life (SF-36 and EQ-5D-5L) in the different groups |
| Costs for the assistive devices | through study completion, an average of 1 year | Calculation of costs (SEK and USD) for the assistive devices |
Countries
Sweden
Outcome results
None listed