Balance Control and Recovery in Diabetes Peripheral Neuropathy

NCT06544876 | Recruiting

• 1 other identifier: STUDY00001512
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy; Diabetic Peripheral Neuropathy Type 2; Diabetic Peripheral Neuropathy Type 2 - Uncontrolled; Healthy Aging

Keywords

diabetic peripheral neuropathy; balance; sensation; aging; older adult; foot; sit-to-stand; falls; falling

Outcome Measures

Primary Outcomes (4)

• Center of pressure using force plate

  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.

  First session (immediately after intervention)

• Center of mass using Vicon cameras.

  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.

  First session (immediately after intervention)

• Joint moment using Nexus software

  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.

  First session (immediately after intervention)

• Local dynamic stability using Motek and Vicon system

  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.

  First session (immediately after intervention)

Secondary Outcomes (4)

• Muscle amplitude using root mean square

  First session (immediately after intervention)

• Muscle onset time using electromyography

  First session (immediately after intervention)

• Muscle co-activation index using EMG

  First session (immediately after intervention)

• Muscle energy frequency using EMG data

  First session (immediately after intervention)

Study Arms (3)

healthy younger adult

ACTIVE COMPARATOR

Behavioral: sit-to-stand; Behavioral: stand to sit; Behavioral: standing perturbation; Other: MRI of sciatic nerve

Healthy older adult

ACTIVE COMPARATOR

Behavioral: sit-to-stand; Behavioral: stand to sit; Behavioral: standing perturbation; Other: MRI of sciatic nerve

older adult with diabetic peripheral neuropathy

EXPERIMENTAL

Behavioral: sit-to-stand; Behavioral: stand to sit; Behavioral: standing perturbation; Other: MRI of sciatic nerve

Interventions

sit-to-stand BEHAVIORAL

test for balance during movement from sitting to standing

Healthy older adult; healthy younger adult; older adult with diabetic peripheral neuropathy

stand to sit BEHAVIORAL

test for balance during movement from standing to sitting

Healthy older adult; healthy younger adult; older adult with diabetic peripheral neuropathy

standing perturbation BEHAVIORAL

test for balance recovery following perturbation

Healthy older adult; healthy younger adult; older adult with diabetic peripheral neuropathy

MRI of sciatic nerve OTHER

measure of peripheral nerve diameter

Healthy older adult; healthy younger adult; older adult with diabetic peripheral neuropathy

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type II diabetes with peripheral neuropathy

You may not qualify if:

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

Sponsors & Collaborators

• Lisa Griffin: lead

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 9, 2024
• Study Start: September 12, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)