The Balance Control Mechanism of DPN Patients

Diabetic Neuropathy Clinical Trial

Official title:

The Balance Control Mechanism of Diabetic Peripheral Neuropathy Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02606747
• Other study ID #: 11372013
• Status: Recruiting
• Phase: N/A
• First received: April 9, 2015
• Last updated: November 16, 2015
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: November 2015
• Source: Peking University
• Contact: Ye Wang, Ph. D
• Phone: +8613718946837
• Email: wangyesmile[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• diabetics

• normal cognitive ability

• walk normally

• normal vision

Exclusion Criteria:

• other nervous system disease, foot ulcer

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Geheng Yuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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).	through study completion, an average of 6 months; timed up and go assessment	Yes
Primary	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	Yes