Reliability and validity of biofeedback insoles for people with diabetes and peripheral neuropathy

Not Applicable

Completed

• Conditions: diabetes; diabetic neuropathy; Metabolic and Endocrine - Diabetes; Neurological - Other neurological disorders

• Registration Number: ACTRN12616001717448
• Lead Sponsor: Wound Management Innovation CRC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Diabetes mellitus type 1 or 2
- Aged 18 years or older
- Peripheral Neuropathy (as determined using a 10-gram Semmes Weinstein monofilament, in line with criteria from the International Working Group on the Diabetic Foot (IWGDF; Schaper et al, 2016)
- Ability and willingness to cooperate with the study requirements

Exclusion Criteria

- Peripheral artery disease, determined by a toe pressure <30mmHg (Hinchliffe et al, 2016)
- Diabetic foot ulcer
- Charcot neuroarthropathy
- Major amputation (i.e. above the ankle)
- Not able to walk for 30m. without external support (e.g. crutches)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliability of centre of pressure displacement of Bio Insole compared to force plate[Over a period of 2 min of standing on the force plate with the insoles in shoes];Validity of peak plantar pressure on Bio Insole relative to pressure obtained from Pedar-X insole[Over a minimum of 12 mid-gait steps per foot at patient's preferred walking speed wearing each insole];Reliability of peak plantar pressure on Bio Insole relative to pressure obtained from Pedar-X insole[Over a minimum of 12 mid-gait steps per foot at patient's preferred walking speed wearing each insole]

Secondary Outcome Measures

Name	Time	Method
Pressure-time integral of Bio Insole compared to Pedar-X insole [Over a minimum of 12 mid-gait steps per foot at patient's preferred walking speed];Force-time integral of Bioinsole compared to Pedar-X insole[Over a minimum of 12 mid-gait steps per foot at patient's preferred walking speed];Validity of centre of pressure displacement of Bio Insole compared to force plate[over a period of 2 min of standing on the force plate with the insoles in shoes]