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Evaluation of balance and neuropathic changes in type 2 diabetic patients.

Not Applicable
Conditions
Involvement of distal regions of limbs in type 2 diabetic patients with peripheral neuropathy.
Type 2 diabetes mellitus with neurological complications
E11.4
Registration Number
IRCT20180409039250N1
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
24
Inclusion Criteria

Patients aged 40 to 65 years old with type 2 diabetes and neuropathy
Patients with ability to walk at least 10 meters without assistance
Fasting Blood Sugar=126 mg/dl or 7 mmol/l
A1c between 7 to 9
Manual muscle test with degree = 3 in plantars, dorsi flexors, evertors, and invertors
Minimum Visual test scale should be 20/40 at dominant eye
Vibratory perception test with diapason (difference in absence vibratory perception between assessors and patients > 10 seconds)
Skin pressure perception test with monofilament
Body Mass Index between 25- 29.9
The absence of diabetic ulcers in either foot or ankle during the study
The absence of severe pain in the lower extremities during the study
The patients should not be involved in regular physical training during the previous 3 months

Exclusion Criteria

Lower extremity fracture
Lower extremity dislocation
Surgery or Lower extremity amputation
Cardiac autonomic neuropathy ( drop in systolic blood pressure of 20 mmHg or diastolic blood pressure of 10mmHg within three minutes after changing the body position from supine to standing.)
Non-diabetic neuropathies
Vestibular system disease
Internal ear infections
Other neurological pathologies
Sever vascular disease (palpation of the posterior of tibial artery and dorsalis pedis )

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Blood sugar. Timepoint: At the begining of the research. Method of measurement: Glucometer.;Stability Index Anterior Posterior(AP), Medial Lateral ( ML) and Overall . Timepoint: At the begining of the research , After 2 weeks, After intervention (After 10 Sessions ), After 2 weeks follow up. Method of measurement: Biodex Balance System.;Physical performance. Timepoint: At the begining of the research , After 2 weeks, After intervention (After 10 Sessions ), After 2 weeks follow up. Method of measurement: Functinal performance tests ( Functional Reach Test, Time Up and Go Test test ).;Vibratory perception, Skin pressure perception, Achilles tendon reflex. Timepoint: At the begining of the research , After 2 weeks, After intervention (After 10 Sessions ), After 2 weeks follow up. Method of measurement: 128 Hz diapason, Monofilament, Hammer Reflex.
Secondary Outcome Measures
NameTimeMethod
europathy assessment. Timepoint: At the begining of the research, After 2 weeks, After intervention ( After 10 sessions), After 2 weeks follow up. Method of measurement: Valk questionnaire (10 questions ).;Neuropathy assessment. Timepoint: At the begining of the research, After 2 weeks, After intervention ( After 10 sessions), After 2 weeks follow up. Method of measurement: Michigan questionnaire ( includs two parts of the history and physical assessment ).;Light Touch Sense. Timepoint: At the begining of the research, After 2 weeks, After intervention ( After 10 sessions), After 2 weeks follow up. Method of measurement: Brushing.
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