Evaluation of a novel wearable aid to improve gait patterns in people with diabetic peripheral neuropathy

Not Applicable

Recruiting

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

• Registration Number: ACTRN12618001477213
• Lead Sponsor: a Trobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-04
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

To be included in the study, participants must:

(i)be aged over 18 years;
(ii)be able to ambulate household distances without a walking aid (justification - this is to ensure they can safely perform the walking tests);
(iii)have symptoms consistent with diabetic peripheral neuropathy (defined as a Diabetic Neuropathy Symptom Score of >0;
(iv)have physical examination findings consistent with diabetic peripheral neuropathy (defined as being unable to detect a 5.07/10 g Semmes-Weinstein monofilament at at least one of three sites on the foot: hallux, 1st metatarsophalangeal joint and 5th metatarsophalangeal joint, and have a vibration perception threshold >25 V using the biothesiometer

Exclusion Criteria

Participants will be excluded if they:

(i)currently have a plantar foot ulcer;
(ii)have had an above- or below-knee amputation;
(iii)have a lower extremity neurological abnormality other than diabetic peripheral neuropathy;
(iv)have a neurodegenerative disease (such as Parkinson’s or Huntington’s disease;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cadence (steps/minute), measured with the GAITRite electronic walkway.[Immediate effects (i.e. immediately after the device has been fitted and the participant walks with it in place) will be assessed.];Step length (cm), measured with the GAITRite electronic walkway.[Immediate effects (i.e. immediately after the device has been fitted and the participant walks with it in place) will be assessed.];Walking speed (metres/second), measured with the GAITRite electronic walkway.[Immediate effects (i.e. immediately after the device has been fitted and the participant walks with it in place) will be assessed.]

Secondary Outcome Measures

Name	Time	Method
Perception of comfort of the device (using question from the validated Monitor Orthopaedic Shoes questionnaire), scored on a 100-mm visual analogue scale.[Immediate effects (i.e immediately after completion of the walking trials) will be assessed.];Perception of ease of donning and doffing device (using question from the validated Monitor Orthopaedic Shoes questionnaire), scored on a 100-mm visual analogue scale.[Immediate effects (i.e immediately after completion of the walking trials) will be assessed.];Perception of heaviness of the device (using question from the validated Monitor Orthopaedic Shoes questionnaire), scored on a 100-mm visual analogue scale.[Immediate effects (i.e immediately after completion of the walking trials) will be assessed.]