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

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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001477213
Acronym
Not applicable
Enrollment
10
Registered
2018-09-04
Start date
2018-10-01
Completion date
2019-10-13
Last updated
2026-09-07

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

Conditions

None listed

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 vibratio

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

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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;

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026