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Trial registered on ANZCTR


Registration number
ACTRN12618001477213
Ethics application status
Approved
Date submitted
21/08/2018
Date registered
4/09/2018
Date last updated
16/12/2020
Date data sharing statement initially provided
9/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a novel wearable aid to improve gait patterns in people with diabetic peripheral neuropathy
Scientific title
Evaluation of a novel wearable aid to improve gait patterns in people with diabetic peripheral neuropathy
Secondary ID [1] 295860 0
None
Universal Trial Number (UTN)
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
diabetic peripheral neuropathy 309327 0
Condition category
Condition code
Neurological 308191 308191 0 0
Other neurological disorders
Metabolic and Endocrine 308276 308276 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312196 0
Treatment: Devices
Comparator / control treatment
The comparator will be no device worn (i.e. participant walks at their normal comfortable speed without any device attached to their legs).
Control group
Active

Outcomes
Primary outcome [1] 307156 0
Walking speed (metres/second), measured with the GAITRite electronic walkway.
Timepoint [1] 307156 0
Immediate effects (i.e. immediately after the device has been fitted and the participant walks with it in place) will be assessed.
Primary outcome [2] 307238 0
Cadence (steps/minute), measured with the GAITRite electronic walkway.
Timepoint [2] 307238 0
Immediate effects (i.e. immediately after the device has been fitted and the participant walks with it in place) will be assessed.
Primary outcome [3] 307239 0
Step length (cm), measured with the GAITRite electronic walkway.
Timepoint [3] 307239 0
Immediate effects (i.e. immediately after the device has been fitted and the participant walks with it in place) will be assessed.
Secondary outcome [1] 350927 0
Perception of comfort of the device (using question from the validated Monitor Orthopaedic Shoes questionnaire), scored on a 100-mm visual analogue scale.
Timepoint [1] 350927 0
Immediate effects (i.e immediately after completion of the walking trials) will be assessed.
Secondary outcome [2] 351219 0
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.
Timepoint [2] 351219 0
Immediate effects (i.e immediately after completion of the walking trials) will be assessed.
Secondary outcome [3] 351220 0
Perception of heaviness of the device (using question from the validated Monitor Orthopaedic Shoes questionnaire), scored on a 100-mm visual analogue scale.
Timepoint [3] 351220 0
Immediate effects (i.e immediately after completion of the walking trials) will be assessed.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. This is a repeated measures study in which all participants will be tested under the three conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be undertaken using SPSS Version 22.0 (IBM, Armonk, NY, USA). Differences between the three conditions (no device, sham device and active device) will be evaluated using repeated measures analysis of variance (ANOVA) with post-hoc tests for pairwise comparisons. The effect sizes for all significant main effects will be calculated using the eta-squared statistic. Participant characteristics and perceptions of the device will be analysed using descriptive statistics. Level of significance will be set at 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
1/10/2018
Date of last participant enrolment
Anticipated
31/07/2021
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
25
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300458 0
University
Name [1] 300458 0
La Trobe University
Country [1] 300458 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Kingsbury Drive
Bundoora 3086
Victoria, Australia
Country
Australia
Secondary sponsor category [1] 299926 0
None
Name [1] 299926 0
Address [1] 299926 0
Country [1] 299926 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301261 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 301261 0
La Trobe University
Kingsbury Drive
Bundoora 3086
Victoria, Australia
Ethics committee country [1] 301261 0
Australia
Date submitted for ethics approval [1] 301261 0
19/07/2018
Approval date [1] 301261 0
24/08/2018
Ethics approval number [1] 301261 0
HEC18339

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86402 0
Prof Hylton B Menz
Address 86402 0
School of Allied Health
College of Science, Health and Engineering
La Trobe University
Bundoora 3086
Victoria, Australia
Country 86402 0
Australia
Phone 86402 0
+61394865801
Fax 86402 0
Email 86402 0
[email protected]
Contact person for public queries
Name 86403 0
Maria Auhl
Address 86403 0
School of Allied Health
College of Science, Health and Engineering
La Trobe University
Bundoora 3086
Victoria, Australia
Country 86403 0
Australia
Phone 86403 0
+61394865258
Fax 86403 0
Email 86403 0
[email protected]
Contact person for scientific queries
Name 86404 0
Hylton B Menz
Address 86404 0
School of Allied Health
College of Science, Health and Engineering
La Trobe University
Bundoora 3086
Victoria, Australia
Country 86404 0
Australia
Phone 86404 0
+61394865801
Fax 86404 0
Email 86404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Small laboratory-based study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4233Clinical study report  [email protected]



Results publications and other study-related documents

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