Clinical trial NCT04054076: 10 Years Follow-up Study of Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
Official title: 10 Years Follow-up of Gait Characteristics, Plantar Pressure, Kinetics and Kinematics in a Cohort of Patients Diagnosed With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetic Foot
Plantar Ulcer
Neuropathy
Gait Disorder, Sensorimotor
Motor Neuropathy
Foot Deformities
Foot Ulcer
Keywords: orthotics
kinematics
kinetics
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak pressure
timeFrame: through study completion, an average of 1 year
measure: Pressure time integral
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Moment at ankle-knee-and hip joint
timeFrame: through study completion, an average of 1 year
measure: Speed
timeFrame: through study completion, an average of 1 year
measure: Cadence
timeFrame: through study completion, an average of 1 year
measure: Stance (percent of stand phase)
timeFrame: through study completion, an average of 1 year
measure: Range of foot-knee and hip angles (minimum to maximum)
timeFrame: through study completion, an average of 1 year
measure: Walking distance of 5 minutes walking
timeFrame: through study completion, an average of 1 year
measure: Distribution of risk grade ( the risk to develop diabetic foot ulcers 1-4(1=no risk, 4=presence of foot ulcers)
timeFrame: through study completion, an average of 1 year
measure: Relation of different types of insoles and risk factors to peak pressure
timeFrame: through study completion, an average of 1 year
measure: Relation of different types of insoles and risk factors to pressure time integral
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Health related quality of life
timeFrame: through study completion, an average of 1 year
measure: Costs for the assistive devices
timeFrame: through study completion, an average of 1 year
Locations:
city: Gothenburg
country: Sweden
facility: Department of Prostetics & Orthotics
state: Region Västragötaland
Study officials:
affiliation: Sahlgrenska University Hospital
name: Björn Stålgren, BSc
role: STUDY_DIRECTOR
References: