NCT02606747|UnknownDMC
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Sponsor study identifier
observational
200
1 country
1
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study will evaluate the balance ability of DPN (diabetic peripheral neuropathy)patients, which will help us to understand the relationship between peripheral and central nervous system, in order to early diagnosis and prevent the fall in DPN patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
April 9, 2015
Actual (reported)November 17, 2015
Actual (reported)June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Berg Balance Scale
In Berg Balance Scale, 14-item scale designed to measure balance of the adult in a clinical setting, including sitting to standing, standing unsupported, sitting unsupported, standing to sitting, transfers, standing with eyes closed, standing with feet together, reaching forward with outstretched arm, retrieving object from floor, turning to look behind, turning 360 degrees, placing alternate foot on stool, standing with one foot in front and standing on one foot. For each item, a five-point scale ranging from 0-4 was recorded. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56.
through study completion, an average of 6 months; Berg Balance Scale assessment
Brain complexity and connectivity
Brain complexity and connectivity was assessed by fMRI (functional magnetic resonance imaging). For each patient, an 8 minutes resting state fMRI signal was recorded. Brain complexity and connectivity was calculated from fMRI signal. By using AAL (automated anatomical labeling) template, the brain was separated into 90 regions. The complexity of each brain region was calculated and range from 50 to 100. "50" indicates the lowest complexity and "100" indicates the highest complexity. The connectivity between each region was also calculated and range from 0 to 1. "0" indicates the weakest connectivity and "1" indicates the strongest connectivity. The brain complexity and connectivity in both DPN group and diabetics without DPN group could help us to explore the brain differences between two groups.
through study completion, an average of 6 months; brain complexity and connectivity assessment
Timed up and go
Timed up and go test was to assess the walk speed of patients. In timed up and go test, the patient sit on a standard armchair and used regular footwear. The patient walk to a line that is 3 meters away, turn around at the line, walk back to the chair, and sit down. The test ends when the patient's buttocks touch the seat. Patients were instructed to use a comfortable and safe walking speed. A stopwatch was used to time the test (in seconds).
Aged from 40 to 80. Normal cognitive ability. Right handed. Able to walk without any other kinds of central nervous system disorder. Confirmed diabetes with DPN.
Aged from 40 to 80. Normal cognitive ability. Right handed. Able to walk without any other kinds of central nervous system disorder. Confirmed diabetes without DPN.
Diabetics
Peking University First Hospital
Beijing, Beijing Municipality, 100000, China
Jue Zhang, Ph. D
PKU
First Submitted
April 9, 2015
First Posted
November 17, 2015
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
A Study In Patients With Neuropathic Pain From Diabetic Peripheral Neuropathy (DPN)
through study completion, an average of 6 months; timed up and go assessment
Foot sole tactile threshold
The foot sole tactile threshold test was to assess the vibration sensation of patients. In foot sole tactile threshold test, the patient was instructed to stand on a pair of vibration insoles. The vibration amplitude was adjusted by experimenter until the patient cannot aware the vibration. The vibration threshold of each foot was recorded from 1 to 100. "1" indicates the weakest vibration and "100" indicates the strongest vibration.
through study completion, an average of 6 months; foot sole tactile threshold assessment
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 17, 2015
Record last verified: 2015-11
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