Balance Control and Recovery in Diabetes Peripheral Neuropathy

NCT ID: NCT06544876

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-12

Study Completion Date

2028-08-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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healthy younger adult

Group Type ACTIVE_COMPARATOR

sit-to-stand

Intervention Type BEHAVIORAL

test for balance during movement from sitting to standing

stand to sit

Intervention Type BEHAVIORAL

test for balance during movement from standing to sitting

standing perturbation

Intervention Type BEHAVIORAL

test for balance recovery following perturbation

MRI of sciatic nerve

Intervention Type OTHER

measure of peripheral nerve diameter

Healthy older adult

Group Type ACTIVE_COMPARATOR

sit-to-stand

Intervention Type BEHAVIORAL

test for balance during movement from sitting to standing

stand to sit

Intervention Type BEHAVIORAL

test for balance during movement from standing to sitting

standing perturbation

Intervention Type BEHAVIORAL

test for balance recovery following perturbation

MRI of sciatic nerve

Intervention Type OTHER

measure of peripheral nerve diameter

older adult with diabetic peripheral neuropathy

Group Type EXPERIMENTAL

sit-to-stand

Intervention Type BEHAVIORAL

test for balance during movement from sitting to standing

stand to sit

Intervention Type BEHAVIORAL

test for balance during movement from standing to sitting

standing perturbation

Intervention Type BEHAVIORAL

test for balance recovery following perturbation

MRI of sciatic nerve

Intervention Type OTHER

measure of peripheral nerve diameter

Interventions

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sit-to-stand

test for balance during movement from sitting to standing

Intervention Type BEHAVIORAL

stand to sit

test for balance during movement from standing to sitting

Intervention Type BEHAVIORAL

standing perturbation

test for balance recovery following perturbation

Intervention Type BEHAVIORAL

MRI of sciatic nerve

measure of peripheral nerve diameter

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lisa Griffin

OTHER

Sponsor Role lead

Responsible Party

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Lisa Griffin

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The University of Texas at Austin

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Mohsen Alighanbari, M.Sc.

Role: primary

512-471-9228

Lisa Griffin, Ph.D.

Role: backup

5124712786

Other Identifiers

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STUDY00001512

Identifier Type: -

Identifier Source: org_study_id

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