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Balance Control and Recovery in Diabetes Peripheral Neuropathy

NCT06544876 · University of Texas at Austin
In plain English

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About this study
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
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-09-12
Estimated completion: 2028-08-31
Last updated: 2024-08-09
Interventions
Behavioral: sit-to-standBehavioral: stand to sitBehavioral: standing perturbationOther: MRI of sciatic nerve
Primary outcomes
  • Center of pressure using force plate (First session (immediately after intervention))
  • Center of mass using Vicon cameras. (First session (immediately after intervention))
  • Joint moment using Nexus software (First session (immediately after intervention))
Sponsor
Lisa Griffin · other
All locations (1)
The University of Texas at AustinRecruiting
Austin, Texas, United States
Balance Control and Recovery in Diabetes Peripheral Neuropathy · TrialPath