None listed
Conditions
Brief summary
Diabetic peripheral neuropathy is a common problem in people with diabetes and may result in unsteadiness when walking. A new wearable device has been developed to improve walking in people with diabetic peripheral neuropathy by providing a vibration stimulus to the legs. The objective of this study to assess the effects of this device on walking patterns.
Interventions
The intervention is a novel wearable device that consists of an accelerometer and vibrotactile actuator contained in a small casing that is attached to both legs with an elastic Velcro® strap. The underlying principle is to replace the sensation of the foot striking the ground that is diminished or absent in people with diabetic peripheral neuropathy. To achieve this, the accelerometer detects the vertical acceleration generated at heel strike, and then immediately applies an equivalent vibration signal to the tibial tuberosity. The device will be attached to participants by research staff. Each device condition (i.e. no device, active device, sham device) will last approximately 20 mins each and there will be a brief (5 min) wash-out period between conditions. The sham device condition involves attaching the device in the standard manner but without the generation of vibration (i.e. the device is turned off). The complete study time will be approximately 2 hours. Testing procedure: 1. Medical history questionnaire and falls risk screening (QuickScreen and Fear of Falling questionnaire) 2. Gait analysis using GaitRite walkway for each of the 3 device conditions (in random order, separated by 5 minute wash-out period). This involves 4 repeat trials of participants walking at their usual comfortable speed along the 830 cm long walkway.
Sponsors
Study design
Eligibility
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;