Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000931279
Ethics application status
Approved
Date submitted
26/10/2009
Date registered
29/10/2009
Date last updated
29/10/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Can lower limb sensory retraining reduce sensory loss after diabetic neuropathy? A randomised controlled pilot study
Scientific title
The effect of sensory neuropathy retraining versus education only on lower limb sensory loss in people aged 40-70 years old with a history of diabetic neuropathy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic neuropathy 252057 0
Condition category
Condition code
Neurological 252260 252260 0 0
Other neurological disorders
Metabolic and Endocrine 252270 252270 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The sensory intervention is based on previous work (Hillier and Dunsford 2006, Lynch et al 2007) and incorporates in each training session a hierarchy of tasks starting with general education about sensation, how it can become altered and the functional consequences of poor sensation. The actual training tasks require the person to practice identifying various sensory stimuli applied randomly across the soles of the foot and they provide responses related to the type of stimulus and the location of the stimulus. The progression of the hierarchy involves more sensitive stimuli, and finer discrimination, based on their previous scores. Stimuli begin with pressure monofilaments and temperature (warm versus cold) and progresses to combination stimuli eg a cold floor tile versus softer warm sand. There is also a task of discriminating foot positions where the person is required to more and more accurately discern the foot position (when repositioned by the therapist). Each session will last a half an hour and the person will be seated or lying comfortably throughout. There will be total of 10 sessions over the 2 week period.
Intervention code [1] 241454 0
Treatment: Other
Comparator / control treatment
educational written document only outlining the effects of diabetes on sensation, the complications of diabetic neuropathy and basic management strategies
Control group
Active

Outcomes
Primary outcome [1] 253124 0
fine touch sensation measured using Semmes-Weinstein monofilaments
Timepoint [1] 253124 0
Pre and Post intervention
Primary outcome [2] 253152 0
Vibration sensation measured using a Biothesiometer
Timepoint [2] 253152 0
Pre and Post intervention
Secondary outcome [1] 258001 0
proprioception sensory appreciation measured usinf the Distal proprioception test
Timepoint [1] 258001 0
Pre and Post intervention

Eligibility
Key inclusion criteria
1. Partial vibratory sensory loss of the lower limb
2. Aged 40-70 years old
3. Able to attend all assessments and interventions
4. Cognitive ability to follow the instructions of the study
5. Give informed consent
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Complete vibratory sensory loss of the lower limb
2. No vibratory sensory loss of the lower limb
3. Inability to understand or respond to questions and instructions
4. History of sensory deficits from other neurological disorders

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243928 0
University
Name [1] 243928 0
University of South Australia
Country [1] 243928 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Cnr Frome Road and North Terrace
Adelaide
South Australia, 5000
Country
Australia
Secondary sponsor category [1] 251285 0
None
Name [1] 251285 0
Nil
Address [1] 251285 0
Nil
Country [1] 251285 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
In summary, diabetes is a major health concern worldwide with its prevalence continuing to increase. Diabetic neuropathy is associated with pain, loss of sensation, loss of ambulation, decreased quality of life and can ultimately result in amputation. Previous studies have shown that central loss of sensation can be decreased with sensory retraining, particularly in people with chronic sensory loss, proving it is more of a “learned” non-use mechanism. Therefore it can be postulated that a sensory retraining intervention for diabetic patients may improve their peripheral sensory appreciation (via attention and practice) which may ultimately lead to improved health and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30418 0
Address 30418 0
Country 30418 0
Phone 30418 0
Fax 30418 0
Email 30418 0
Contact person for public queries
Name 13665 0
Susan Hillier
Address 13665 0
Division of Health Sciences,
University of South Australia, City East Campus
Cnr Frome Road and North Terrace
Adelaide
South Australia, 5000
Country 13665 0
Australia
Phone 13665 0
+61 8 8302 2544
Fax 13665 0
Email 13665 0
Susan.Hillier@unisa.edu.au
Contact person for scientific queries
Name 4593 0
Susan Hillier
Address 4593 0
Division of Health Sciences,
University of South Australia, City East Campus
Cnr Frome Road and North Terrace
Adelaide
South Australia, 5000
Country 4593 0
Australia
Phone 4593 0
+61 8 8302 2544
Fax 4593 0
Email 4593 0
Susan.Hillier@unisa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.