Studying the role of the foot and ankle properioception on dynamic balance, neuropathic changes and physical performance after ankle balance training in type 2 diabetic patients with peripheral neuropathy.
Studying the role of the foot properioception on dynamic balance, neuropathy and physical performance after ankle balance training in type 2 diabetic patients
Design
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
Settings and conduct
This study examines the role of the foot proprioception in type 2 diabetic Patients with neuropathy. 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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Anterior Posterior, Medial Lateral and Overall stability index, Functional Reach Test, Time Up and Go Test, Vibration perception, Skin sensation perception
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180409039250N1
Registration date:2018-11-08, 1397/08/17
Registration timing:prospective
Last update:2018-11-08, 1397/08/17
Update count:1
Registration date
2018-11-08, 1397/08/17
Registrant information
Name
Mahdieh Ravand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 29901
Email address
ravand@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-17, 1397/08/26
Expected recruitment end date
2019-03-17, 1397/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the role of the foot and ankle properioception on dynamic balance, neuropathic changes and physical performance after ankle balance training in type 2 diabetic patients with peripheral neuropathy.
Public title
Studying the role of the foot on balance in type 2 diabetic patients.
Purpose
Diagnostic
Inclusion/Exclusion criteria
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 )
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding outcome assessor by employing a person other than the researcher in order to reduce the bias in the study
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the shahid beheshti university of medical science
Street address
Physiotherapy group, Rehabilitation Science School Of Shahid Beheshti Medical University., Damavnd Ave
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2018-10-20, 1397/07/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.589
Health conditions studied
1
Description of health condition studied
Involvement of distal regions of limbs in type 2 diabetic patients with peripheral neuropathy
ICD-10 code
E11.4
ICD-10 code description
Type 2 diabetes mellitus with neurological complications
Primary outcomes
1
Description
Blood sugar
Timepoint
At the begining of the research
Method of measurement
Glucometer
2
Description
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
3
Description
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 )
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 outcomes
1
Description
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 )
2
Description
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 )
3
Description
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
Intervention groups
1
Description
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
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology & Metabolism Institute of Shariati Hospital
Full name of responsible person
Mohammad Reza Mohajeri Tehrani
Street address
5 floor, Shariati Hospital, Shomali Kargar Ave,
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8822 0071
Fax
+98 21 8822 0052
Email
mrmohajeri@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Akbarzade baghban
Street address
Physiotherapy group, Rehabilitation Science School Of Shahid Beheshti Medical University., Damavnd Ave
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
aakbarzad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdieh Ravand
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 63, 31 Ave, Gisha Street,
City
Tehran
Province
Tehran
Postal code
1447914183
Phone
+98 88257410
Email
mahdiehravand@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdieh Ravand
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 63, 31 Ave, Gisha Street,
City
Tehran
Province
Tehran
Postal code
1447914183
Phone
+98 88257410
Email
mahdiehravand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahdieh Ravand
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 63, 31 Ave, Gisha Street,
City
Tehran
Province
Tehran
Postal code
1447914183
Phone
+98 88257410
Email
mahdiehravand@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All collected data can be shared after deidentification of the patients
When the data will become available and for how long
All the data can be available 3 months after publication
To whom data/document is available
All of the academic researchers and clinicians
Under which criteria data/document could be used
Research & therapeutic use is permitted
From where data/document is obtainable
Contact with corresponding
What processes are involved for a request to access data/document