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Trial registered on ANZCTR


Registration number
ACTRN12609000781246
Ethics application status
Approved
Date submitted
3/09/2009
Date registered
9/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physical Therapy in an elderly with diabetic neuropathy: case report
Scientific title
Physical Therapy in an elderly with diabetic neuropathy: case report
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic neuropathy and diabetic foot 243624 0
diabetic neuropathy 243669 0
Condition category
Condition code
Physical Medicine / Rehabilitation 239924 239924 0 0
Other physical medicine / rehabilitation
Musculoskeletal 239939 239939 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this case report was to evaluate the effects of a physical therapy intervention in a diabetic neuropathy elderly, through the development of a treatment.The treatment was composed by metabolic exercises, stretching and muscle strengthening, balance training, gait training, classic massage and feet self-care orientation. There were 24 sessions of treatment, (40 minutes each session), twice a week, during 3 months. A trained physiotherapist administered de sessions.
Intervention code [1] 241213 0
Rehabilitation
Comparator / control treatment
There wasn´t a control group. A sensorial, motor, functional assessment and the Foot Health Status Questionnaire (FHSQ-Brasil) were implemented in three phases: pre-intervention, after 12 sessions and after de physical therapy treatment (24 sessions). The results were based in the same participant on different stages.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240703 0
perimetry (legs),
Timepoint [1] 240703 0
3 timepoints: pre-intervention, after 12 sessions of treatment and after intervention.
Primary outcome [2] 240740 0
tactile sensibility, assessed by Semmes-Weistein monofilaments on 10 feet points.
Timepoint [2] 240740 0
3 timepoints: pre-intervention, after 12 sessions of treatment and after intervention.
Primary outcome [3] 240741 0
pain, by visual analogic scale (0= no pain and 10= the worst pain ever)
Timepoint [3] 240741 0
3 timepoints: pre-intervention, after 12 sessions of treatment and after intervention.
Primary outcome [4] 240742 0
proprioceptive sensibility, by a neuromuscular test. The toe will be posicioned and the patient should answer the direction and the movement of the toe.
Timepoint [4] 240742 0
3 timepoints: pre-intervention, after 12 sessions of treatment and after intervention.
Primary outcome [5] 240743 0
balance, assessed by 3 clinicaltests: tandem position, semi-tandem position and one leg position.
Timepoint [5] 240743 0
3 timepoints: pre-intervention, after 12 sessions of treatment and after intervention.
Primary outcome [6] 240744 0
range of movement, assessed by a goniometer.
Timepoint [6] 240744 0
3 timepoints: pre-intervention, after 12 sessions of treatment and after intervention.
Primary outcome [7] 240745 0
strenght, assessed by kendall descriptions of strengt test. (manual test)
Timepoint [7] 240745 0
3 timepoints: pre-intervention, after 12 sessions of treatment and after intervention.
Secondary outcome [1] 257359 0
Health status of the foot by a questionnaire (Foot Health Status Questionnaire (FHSQ)
Timepoint [1] 257359 0
3 timepoints: pre-intervention, after 12 sessions of treatment and after intervention.
Secondary outcome [2] 257395 0
adherence to feet self-care orientation
Timepoint [2] 257395 0
3 timepoints: pre-intervention, after 12 sessions of treatment and after intervention.

Eligibility
Key inclusion criteria
elderly, diagosis of diabetes melittus (tipe II), diagnosis of diabetic neuropathy, glicemic control, absence of diabetic ulcers, hability to walk with or without external support, preserved cognition and visual capacity.
Minimum age
60 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
presence of diabetic ulcers

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1977 0
Brazil
State/province [1] 1977 0
Country [2] 1978 0
Brazil
State/province [2] 1978 0

Funding & Sponsors
Funding source category [1] 237572 0
Self funded/Unfunded
Name [1] 237572 0
Fernanda Pretti Chalet Ferreira and Karina Vasconcelos
Address [1] 237572 0
Rua Cel. Palimercio de Rezende,282
Country [1] 237572 0
Brazil
Primary sponsor type
University
Name
Centro Universitario Sao Camilo
Address
Avenida Nazare, 1501. Sao Paulo, S.P.
04261-000
Country
Brazil
Secondary sponsor category [1] 237047 0
None
Name [1] 237047 0
Address [1] 237047 0
Country [1] 237047 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243698 0
Comissao de etica e Pesquisa do Centro Universitrio Sao Camilo
Ethics committee address [1] 243698 0
Av. Nazare, 1501. Sao Paulo
04261-000
Ethics committee country [1] 243698 0
Brazil
Date submitted for ethics approval [1] 243698 0
Approval date [1] 243698 0
Ethics approval number [1] 243698 0

Summary
Brief summary
Due the fact of the large number of diabetis incidence , the primary purpose of this study is to test a preventive treatment for diabetic ulcers as so the others diabetic neuropathy´s complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30113 0
Address 30113 0
Country 30113 0
Phone 30113 0
Fax 30113 0
Email 30113 0
Contact person for public queries
Name 13360 0
Fernanda Pretti Chalet Ferreira
Address 13360 0
Rua Coronel Palimercio de Rezende, 282
05505-010
Country 13360 0
Brazil
Phone 13360 0
+55 11-76778578/ +55 11-30312394
Fax 13360 0
Email 13360 0
fisio_pretti@hotmail.com
Contact person for scientific queries
Name 4288 0
Fernanda Pretti Chalet Ferreira
Address 4288 0
Rua Coronel Palimercio de Rezende, 282
05505-010
Country 4288 0
Brazil
Phone 4288 0
+55 11-76778578/+55 11-30312394
Fax 4288 0
Email 4288 0
fisio_pretti@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary