Balance Control and Recovery in Diabetes Peripheral Neuropathy (DPN)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Aging; Diabetic Peripheral Neuropathy; Diabetic Peripheral Neuropathy Type 2; Diabetic Peripheral Neuropathy Type 2 - Uncontrolled
• Intervention / Treatment: Behavioral: sit-to-stand; Behavioral: stand to sit; Behavioral: standing perturbation; Other: MRI of sciatic nerve

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • The University of Texas at Austin
      • Contact: Mohsen Alighanbari, M.Sc.; Phone Number: 512-471-9228; Email: m.alighanbari@utexas.edu
      • Contact: Lisa Griffin, Ph.D.; Phone Number: 5124712786; Email: l.griffin@austin.utexas.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: healthy younger adult	Behavioral: sit-to-stand; test for balance during movement from sitting to standing; Behavioral: stand to sit; test for balance during movement from standing to sitting; Behavioral: standing perturbation; test for balance recovery following perturbation; Other: MRI of sciatic nerve; measure of peripheral nerve diameter
Active Comparator: Healthy older adult	Behavioral: sit-to-stand; test for balance during movement from sitting to standing; Behavioral: stand to sit; test for balance during movement from standing to sitting; Behavioral: standing perturbation; test for balance recovery following perturbation; Other: MRI of sciatic nerve; measure of peripheral nerve diameter
Experimental: older adult with diabetic peripheral neuropathy	Behavioral: sit-to-stand; test for balance during movement from sitting to standing; Behavioral: stand to sit; test for balance during movement from standing to sitting; Behavioral: standing perturbation; test for balance recovery following perturbation; Other: MRI of sciatic nerve; measure of peripheral nerve diameter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle amplitude using root mean square	Muscle amplitude will be collected using Delsys Tringo wireless surface electromyography (EMG). The EMG electrodes will be attached with double adhesive tape. Then, EMG amplitudes will be assessed using the root mean square technique in MATLAB software. Higher amplitude represents higher muscle activity.	First session (immediately after intervention)
Muscle onset time using electromyography	The muscle onset time will be assessed using MATLAB code. An abrupt change in the EMG trace is defined as a muscle onset time. Any change in EMG onset time represents impairment in neuromuscular junctions or muscle and nerve electrical conduction.	First session (immediately after intervention)
Muscle co-activation index using EMG	The coactivation index will be assessed between two muscles in the same participant using MATLAB syntax. An increase in muscle coactivation represents an increase in active joint stiffness. This increase in active joint stiffness reduces the resultant joint moment, leading to impaired smoothness of movement and reducing the ability to perform daily activities.	First session (immediately after intervention)
Muscle energy frequency using EMG data	Wavelet transform can identify the contribution of different muscle fibers (large or small, fast or slow twitch fibers) in the same task. Assessment of this method indicates what fiber type is affected by DPN.	First session (immediately after intervention)

Collaborators and Investigators

• Sponsor: Lisa Griffin

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: aging; falls; balance; sensation; falling; foot; older adult; diabetic peripheral neuropathy; sit-to-stand
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: STUDY00001512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No