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IRCT20180409039250N1 IRCT 2018-11-08 Shahid Beheshti University of Medical Sciences Evaluation of balance and neuropathic changes in type 2 diabetic patients. Evaluation of functional balance, dynamic balance, and neuropathic changes in patients with Type 2 diabetes following ankle proprioceptive training 2018-11-17 anticipated 24 Complete https://irct.ir/trial/30703 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic, Blinding description: Blinding outcome assessor by employing a person other than the researcher in order to reduce the bias in the study. N/A Involvement of distal regions of limbs in type 2 diabetic patients with peripheral neuropathy. Ankle proprioception exercise composed of training on the rocker and wobble boards and on both feet. Rocker board exercise will perform in both plantar & dorsi, right & left directions. Each exercise will perform five times, each time takes 15s and there is 45s rest between the repititions. Progress training are including eyes open and head forward, eyes closed and head forward, eyes open and head back, eyes closed and head back, decreasing the visual and vestibular inputs, the amount of external support and rest interval and increasing the exercise duration gradually during sessions. Also they have walking program twice a week for 30 minutes and have general instructions for blood glucose control. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further infomation
public Mahdieh Ravand
No. 63, 31 Ave, Gisha Street,
Tehran Iran (Islamic Republic of) 1447914183 +98 88257410 mahdiehravand@gmail.com Shahid Beheshti University of Medical Sciences scientific Mahdieh Ravand
No. 63, 31 Ave, Gisha Street,
Tehran Iran (Islamic Republic of) 1447914183 +98 88257410 mahdiehravand@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 40 years 65 years Both 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 ) E11.4 Type 2 diabetes mellitus with neurological complications Diagnosis Ankle proprioception exercise composed of training on the rocker and wobble boards and on both feet. Rocker board exercise will perform in both plantar & dorsi, right & left directions. Each exercise will perform five times, each time takes 15s and there is 45s rest between the repititions. Progress training are including eyes open and head forward, eyes closed and head forward, eyes open and head back, eyes closed and head back, decreasing the visual and vestibular inputs, the amount of external support and rest interval and increasing the exercise duration gradually during sessions. Also they have walking program twice a week for 30 minutes and have general instructions for blood glucose control 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. 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: 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. Shahid Beheshti University of Medical Sciences Approved 2018-10-20 Ethics committee of the Shahid Beheshti University Of Medical Science Physiotherapy group, Rehabilitation Science School Of Shahid Beheshti Medical University., Damavnd Ave Tehran Tehran Iran (Islamic Republic of)