Protocol summary
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Study aim
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Evaluation of functional balance, dynamic balance, and neuropathic changes in patients with Type 2 diabetes following ankle proprioceptive training
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Design
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Semi experimental study, 24 patients with type 2 diabetes and moderate neuropathy with abscence of control group, not randomized and convenience with blinded outcome assessor
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Settings and conduct
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This study evaluates the functional balance, dynamic balance, and neuropathic changes in type 2 diabetic patients with neuropathy following ankle proprioceptive training. At first Patients refer to the endocrinology clinic and then qualified patients will perform balance and neuropathy tests in Shahid Beheshti Rehabilitation Faculty Laboratory and clinic at different Sessions. The exercises will perform on balance boards in different modes for 10 sessions. The study is single blinded by individual assignment as an outcome assessor.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria : patients aged 40-65 years old with at least five years history of type 2 diabetes and neuropathy, Fasting Blood Sugar ≥126 mg/dl, manual muscle test with degree ≥ 3 in the ankle muscles, Visual test score of at least 20.40 at dominant eye, Body Mass Index between 25-29.9 kg.m2 with vibration perception disorder.
Exclusion criteria : patients with foot ulcer, non-diabetic neuropathy, orthopedic, neurologic and amputation problems.
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Intervention groups
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The exercises will perform on Wobble and Rocker boards in both plantar and dorsi, right and left directions for 10 sessions. Each exercise conducts for five times and each time takes 15s to perform with a 45s rest between the repetitions. Walking and training programs is also planned to monitor blood glucose.
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Main outcome variables
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Anterior Posterior, Medial Lateral and Overall stability index, Functional Reach Test, Time Up and Go Test, Vibration perception, Skin sensation perception
General information
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Reason for update
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The study is over. it is also necessary to make some minor changes, for example in the title.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180409039250N1
Registration date:
2018-11-08, 1397/08/17
Registration timing:
prospective
Last update:
2021-10-23, 1400/08/01
Update count:
1
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Registration date
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2018-11-08, 1397/08/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-17, 1397/08/26
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Expected recruitment end date
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2019-03-17, 1397/12/26
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Actual recruitment start date
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2018-12-12, 1397/09/21
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Actual recruitment end date
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2019-09-16, 1398/06/25
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Trial completion date
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2019-09-16, 1398/06/25
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Scientific title
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Evaluation of functional balance, dynamic balance, and neuropathic changes in patients with Type 2 diabetes following ankle proprioceptive training
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Public title
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Evaluation of balance and neuropathic changes in type 2 diabetic patients.
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Purpose
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Diagnostic
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Inclusion/Exclusion criteria
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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 )
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Age
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From 40 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
24
Actual sample size reached:
24
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Blinding outcome assessor by employing a person other than the researcher in order to reduce the bias in the study
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-10-20, 1397/07/28
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1397.589
Health conditions studied
1
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Description of health condition studied
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Involvement of distal regions of limbs in type 2 diabetic patients with peripheral neuropathy
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ICD-10 code
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E11.4
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ICD-10 code description
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Type 2 diabetes mellitus with neurological complications
Primary outcomes
1
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Description
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Blood sugar
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Timepoint
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At the begining of the research
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Method of measurement
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Glucometer
2
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Description
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Stability Index " Anterior Posterior(AP), Medial Lateral ( ML) and Overall "
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Timepoint
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At the begining of the research , After 2 weeks, After intervention (After 10 Sessions ), After 2 weeks follow up
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Method of measurement
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Biodex Balance System
3
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Description
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Physical performance
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Timepoint
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At the begining of the research , After 2 weeks, After intervention (After 10 Sessions ), After 2 weeks follow up
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Method of measurement
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Functinal performance tests ( Functional Reach Test, Time Up and Go Test test )
4
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Description
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Vibratory perception, Skin pressure perception, Achilles tendon reflex
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Timepoint
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At the begining of the research , After 2 weeks, After intervention (After 10 Sessions ), After 2 weeks follow up
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Method of measurement
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128 Hz diapason, Monofilament, Hammer Reflex
Secondary outcomes
1
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Description
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Neuropathy assessment
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Timepoint
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At the begining of the research, After 2 weeks, After intervention ( After 10 sessions), After 2 weeks follow up
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Method of measurement
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Valk questionnaire (10 questions )
2
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Description
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Neuropathy assessment
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Timepoint
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At the begining of the research, After 2 weeks, After intervention ( After 10 sessions), After 2 weeks follow up
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Method of measurement
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Michigan questionnaire ( includs two parts of the history and physical assessment )
3
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Description
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Light Touch Sense
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Timepoint
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At the begining of the research, After 2 weeks, After intervention ( After 10 sessions), After 2 weeks follow up
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Method of measurement
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Brushing
Intervention groups
1
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Description
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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
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Category
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Diagnosis
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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All collected data can be shared after deidentification of the patients
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When the data will become available and for how long
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All the data can be available 3 months after publication
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To whom data/document is available
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All of the academic researchers and clinicians
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Under which criteria data/document could be used
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Research & therapeutic use is permitted
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From where data/document is obtainable
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Contact with corresponding
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What processes are involved for a request to access data/document
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Accurate features of applicant
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Comments
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