Balance Control and Recovery in Diabetes Peripheral Neuropathy (DPN)

Lisa Griffin

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06544876

STUDY00001512

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

healthy younger adult

Active Comparator group

Treatment:

Behavioral: stand to sit

Behavioral: standing perturbation

Other: MRI of sciatic nerve

Behavioral: sit-to-stand

Healthy older adult

Active Comparator group

Treatment:

Behavioral: stand to sit

Behavioral: standing perturbation

Other: MRI of sciatic nerve

Behavioral: sit-to-stand

older adult with diabetic peripheral neuropathy

Experimental group

Treatment:

Behavioral: stand to sit

Behavioral: standing perturbation

Other: MRI of sciatic nerve

Behavioral: sit-to-stand