NCT06544876

Balance Control and Recovery in Diabetes Peripheral Neuropathy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Lisa Griffin · Academic / Other
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-12
• Primary completion: 2026-08-31
• Completion: 2028-08-31
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: United States