Individually optimized rocker profile and self-adapting insole to reduce the plantar peak pressure in Diabetic patients with loss of protective sensatio

Completed

Conditions: peak pressure
plantar pressure
10012653
10034606

Registration Number: NL-OMON52218

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

For the Diabetic patients:
Adult
Diabetes mellitus (type I or II)
Loss of protective sensation (10 gr filament & 128Hz tunning fork)
Ambulatory without use of walking aids (with the exception of the use of
orthopaedic footwear)
Shoe size between 36 and 46

For the healthy reference group:
Ambulatory without use of walking aids
Age between 40-70 year
Shoe size between 36-46

Exclusion Criteria

For the Diabetic patients:
Current ulcer(s) and ulcer(s) in the past
Use of walking aids (with the exception of the use of orthopaedic footwear)
Extreme foot deformations (e.g. Charcot foot) or toe or foot amputations that
do not allow participants to fit semi-ready-to-wear shoes
Body weight >130kg

For the healthy reference group:
Use of walking aids
Foot complications (injuries that can influence gait) that do not allow
participants to fit ready-to-wear shoes
Body weight >130kg
Any self-reported injury or disease that affects walking ability

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- In-shoe plantar pressures, measured with a pressure insole (Pedar-X):<br /><br>1. Peak Pressures (PP)<br /><br>2. Pressure Time Integral (PTI)<br /><br>- Balance with and without perturbations, measured with clinical tests and the<br /><br>force plate treadmill (and Vicon system) of the GRAIL lab of the Center for<br /><br>Rehabilitation of the UMCG, Beatrixoord:<br /><br>1. Time taken to stand up-walk- and sit (TUG)<br /><br>2. Root Mean Square (RMS) of net anterior-posterior (AP) & medio-lateral (ML)<br /><br>direction during eyes open and closed condition (static balance)<br /><br>3. Margins of stability during normal gait, AP & ML perturbations (dynamic<br /><br>balance)</p><br>

Secondary Outcome Measures