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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52218

Enrollment

Registered

2021-03-11

Start date

2021-06-23

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peak pressure plantar pressure

Interventions

1) Unadapted reference shoe (Dr.Comfort, Mequon, WI, USA) + standard insole (visit 1) 2) Unadapted reference shoe + self-adjusting insole (visit 2) 3) Rocker shoe + standard insole (visit 2) 4) Rocke

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
kinetics and kinematics of the lower extremity	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)