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Clinical Trials/NCT06544876
NCT06544876
Recruiting
N/A

Balance Control and Recovery in Diabetes Peripheral Neuropathy

Lisa Griffin1 site in 1 country60 target enrollmentSeptember 12, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic Peripheral Neuropathy
Sponsor
Lisa Griffin
Enrollment
60
Locations
1
Primary Endpoint
Center of mass using Vicon cameras.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

In this study the effects of diabetic peripheral neuropathy will be assessed on balance control, balance recovery, and muscle electrical activity in adults over 50 years.

Aim 1: Determine muscle activity and balance control during a sit-to-stand in adults age above 50 with and without diabetic peripheral neuropathy.

Aim 2: Assess local balance recovery and latency responses to lateral surface perturbation during quiet standing.

Detailed Description

Diabetic peripheral neuropathy (DPN) is a common condition affecting patients with diabetes. The prevalence of DPN increases with age and the duration of having diabetes. Approximately 30% of patients with diabetes have peripheral neuropathy globally, and 4.5 million Americans have DPN. DPN typically affects more distal peripheral nerve branches, resulting in sensory loss. DPN causes axonal damage and leads to a loss of muscle strength. These degenerative effects significantly contribute to fall risks and feelings of instability. Falls most commonly occur during transitional tasks such as the sit-to-stand (STS) and stand-to-sit (StandTS). The overall objective of this study to assess the effects of DPN on balance control and muscle activity during transitional tasks (STS and StandTS) and during lateral perturbation while standing. Study procedures: 1. Measures of body weight, height, and limb diameter and measuring including leg length, knee width, elbow width, wrist width, and hand thickness. 2. Measures of sensation of the big toe and heel area for both legs. 3. Surface sensors will be placed on the leg muscles using non-allergic double adhesive tape. 4. Participants will sit down and stand up on a chair with adjustable height. 5. Then, participants will be asked to stand on a treadmill holding a ruler. The treadmill will slightly move left and right, and the muscle activity and balance control will be evaluated. 6. Finally, muscle strength of the legs' muscles will be collected.

Registry
clinicaltrials.gov
Start Date
September 12, 2023
End Date
August 31, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Lisa Griffin

Associate Professor

University of Texas at Austin

Eligibility Criteria

Inclusion Criteria

  • Type II diabetes with peripheral neuropathy

Exclusion Criteria

  • Foot ulcer
  • Partial amputation
  • Have experience of Stroke
  • Painful neuropathy
  • Inability to stand or walk independently

Outcomes

Primary Outcomes

Center of mass using Vicon cameras.

Time Frame: First session (immediately after intervention)

Center-of-mass sway volume will be assessed as the participant will walk in front of a high-speed camera, which will be recorded using the retroreflective markers. Then, a mathematical approach will be used to fit an ellipsoid to the data samples for each group. Higher sway volume means impairment in balance.

Joint moment using Nexus software

Time Frame: First session (immediately after intervention)

Joint moments will be assessed between groups using Vicon and force plates. This variable will be obtained using Nexus software, which combines both the inputs from Vicon and force plates.

Local dynamic stability using Motek and Vicon system

Time Frame: First session (immediately after intervention)

Local dynamic stability will be assessed using the Motek treadmill and Vicon cameras. The Motek treadmill will provide the left and right perturbation, and the Vicon system will collect the kinematic data. Then, the MATLAB code will calculate local dynamic stability to identify impairment in balance recovery.

Center of pressure using force plate

Time Frame: First session (immediately after intervention)

Center-of-pressure sway will be assessed between groups. As participants sit down or stand up from a chair on the force plates, the ground reaction force will be collected. Then, using a mathematical approach, an ellipse will be fitted to the data to calculate the sway area. A higher sway area indicates an impairment during balance control.

Secondary Outcomes

  • Muscle co-activation index using EMG(First session (immediately after intervention))
  • Muscle amplitude using root mean square(First session (immediately after intervention))
  • Muscle onset time using electromyography(First session (immediately after intervention))
  • Muscle energy frequency using EMG data(First session (immediately after intervention))

Study Sites (1)

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