The Balance Control Mechanism of DPN Patients

NCT02606747 | Unknown DMC

• 1 other identifier: 11372013
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy

Keywords

DPN; fall; fMRI; balance

Outcome Measures

Primary Outcomes (4)

• 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).

  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

Study Arms (2)

Diabetes mellitus 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 with DPN.

Diabetes mellitus without 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.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetics

You may qualify if:

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

You may not qualify if:

• other nervous system disease, foot ulcer

Sponsors & Collaborators

• Geheng Yuan: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Jue Zhang, Ph. D

  PKU

  STUDY CHAIR

Central Study Contacts

Ye Wang, Ph. D

CONTACT

+8613718946837; wangyesmile@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Peking University first hospital

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: November 17, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

CN (1)