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Clinical Trials/NCT02606747
NCT02606747
Unknown
N/A

The Balance Control Mechanism of Diabetic Peripheral Neuropathy Patients

Geheng Yuan1 site in 1 country200 target enrollmentMarch 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic Neuropathy
Sponsor
Geheng Yuan
Enrollment
200
Locations
1
Primary Endpoint
Berg Balance Scale
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

DPN is one of the most common complications of diabetes. The clinical manifestation of DPN contains sensory reduction, pain, muscle wastage and so on. Sensory and motor nervous are one of the most important factors in balance control, the reduction of balance ability will result in high risk of fall. Most studies about DPN are focus on peripheral nervous, however, the central nervous system may also be involved in DPN patients. In this study, force platform, proprioception test and fMRI will be used to evaluate balance ability, proprioception and the brain function information of DPN patients, which will help to understand the relationship between peripheral and central nervous system.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
June 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Geheng Yuan
Responsible Party
Sponsor Investigator
Principal Investigator

Geheng Yuan

Peking University first hospital

Peking University

Eligibility Criteria

Inclusion Criteria

  • diabetics
  • normal cognitive ability
  • walk normally
  • normal vision

Exclusion Criteria

  • other nervous system disease, foot ulcer

Outcomes

Primary Outcomes

Berg Balance Scale

Time Frame: through study completion, an average of 6 months; Berg Balance Scale assessment

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.

Brain complexity and connectivity

Time Frame: through study completion, an average of 6 months; brain complexity and connectivity assessment

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.

Foot sole tactile threshold

Time Frame: through study completion, an average of 6 months; foot sole tactile threshold assessment

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.

Timed up and go

Time Frame: through study completion, an average of 6 months; timed up and go assessment

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).

Study Sites (1)

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