Skip to main content
Clinical Trials/ACTRN12618001477213
ACTRN12618001477213
Recruiting
N/A

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

a Trobe University0 sites25 target enrollmentSeptember 4, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
diabetic peripheral neuropathy
Sponsor
a Trobe University
Enrollment
25
Status
Recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 4, 2018
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
a Trobe University

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Not specified

Similar Trials