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The Balance Control Mechanism of DPN Patients

The Balance Control Mechanism of Diabetic Peripheral Neuropathy Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02606747
Enrollment
200
Registered
2015-11-17
Start date
2015-03-31
Completion date
2016-06-30
Last updated
2015-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy

Keywords

DPN, fall, fMRI, balance

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.

Interventions

None listed

Sponsors

Geheng Yuan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* diabetics * normal cognitive ability * walk normally * normal vision

Exclusion criteria

* other nervous system disease, foot ulcer

Design outcomes

Primary

MeasureTime frameDescription
Berg Balance Scalethrough study completion, an average of 6 months; Berg Balance Scale assessmentIn 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 connectivitythrough study completion, an average of 6 months; brain complexity and connectivity assessmentBrain 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.
Timed up and gothrough study completion, an average of 6 months; timed up and go assessmentTimed 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).
Foot sole tactile thresholdthrough study completion, an average of 6 months; foot sole tactile threshold assessmentThe 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.

Countries

China

Contacts

Primary ContactYe Wang, Ph. D
wangyesmile@gmail.com+8613718946837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026