Balance Control and Recovery in Diabetes Peripheral Neuropathy
NCT Number: NCT06544876
Acronym: DPN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetic Peripheral Neuropathy|Diabetic Peripheral Neuropathy Type 2|Diabetic Peripheral Neuropathy Type 2 - Uncontrolled|Healthy Aging
Interventions: BEHAVIORAL: sit-to-stand|BEHAVIORAL: stand to sit|BEHAVIORAL: standing perturbation|OTHER: MRI of sciatic nerve
Sponsor: Lisa Griffin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-09-12
Completion Date: 2028-08-31
Locations: The University of Texas at Austin, Austin, Texas, 78712, United States

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.

Primary Outcome Measures: Center of pressure using force plate, Center-of-pressure sway will be assessed between groups. As participants sit down or stand up from a chair on the force plates, the ground reaction force will be collected. Then, using a mathematical approach, an ellipse will be fitted to the data to calculate the sway area. A higher sway area indicates an impairment during balance control., First session (immediately after intervention)|Center of mass using Vicon cameras., Center-of-mass sway volume will be assessed as the participant will walk in front of a high-speed camera, which will be recorded using the retroreflective markers. Then, a mathematical approach will be used to fit an ellipsoid to the data samples for each group. Higher sway volume means impairment in balance., First session (immediately after intervention)|Joint moment using Nexus software, Joint moments will be assessed between groups using Vicon and force plates. This variable will be obtained using Nexus software, which combines both the inputs from Vicon and force plates., First session (immediately after intervention)|Local dynamic stability using Motek and Vicon system, Local dynamic stability will be assessed using the Motek treadmill and Vicon cameras. The Motek treadmill will provide the left and right perturbation, and the Vicon system will collect the kinematic data. Then, the MATLAB code will calculate local dynamic stability to identify impairment in balance recovery., First session (immediately after intervention)
Secondary Outcome Measures: Muscle amplitude using root mean square, Muscle amplitude will be collected using Delsys Tringo wireless surface electromyography (EMG). The EMG electrodes will be attached with double adhesive tape. Then, EMG amplitudes will be assessed using the root mean square technique in MATLAB software. Higher amplitude represents higher muscle activity., First session (immediately after intervention)|Muscle onset time using electromyography, The muscle onset time will be assessed using MATLAB code. An abrupt change in the EMG trace is defined as a muscle onset time. Any change in EMG onset time represents impairment in neuromuscular junctions or muscle and nerve electrical conduction., First session (immediately after intervention)|Muscle co-activation index using EMG, The coactivation index will be assessed between two muscles in the same participant using MATLAB syntax. An increase in muscle coactivation represents an increase in active joint stiffness. This increase in active joint stiffness reduces the resultant joint moment, leading to impaired smoothness of movement and reducing the ability to perform daily activities., First session (immediately after intervention)|Muscle energy frequency using EMG data, Wavelet transform can identify the contribution of different muscle fibers (large or small, fast or slow twitch fibers) in the same task. Assessment of this method indicates what fiber type is affected by DPN., First session (immediately after intervention)