Clinical trial NCT06544876: Balance Control and Recovery in Diabetes Peripheral Neuropathy
Official title: Balance Control and Recovery in Diabetes Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Center of pressure using force plate
timeFrame: First session (immediately after intervention)
measure: Center of mass using Vicon cameras.
timeFrame: First session (immediately after intervention)
measure: Joint moment using Nexus software
timeFrame: First session (immediately after intervention)
measure: Local dynamic stability using Motek and Vicon system
timeFrame: First session (immediately after intervention)
Secondary outcomes:
measure: Muscle amplitude using root mean square
timeFrame: First session (immediately after intervention)
measure: Muscle onset time using electromyography
timeFrame: First session (immediately after intervention)
measure: Muscle co-activation index using EMG
timeFrame: First session (immediately after intervention)
measure: Muscle energy frequency using EMG data
timeFrame: First session (immediately after intervention)
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
References: