An interventional study of sit-to-stand and stand to sit in Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathy Type 2 and Diabetic Peripheral Neuropathy Type 2 - Uncontrolled, sponsored by Lisa Griffin. Recruiting at 1 site in United States. Open to participants aged 50 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Lisa Griffin · Not applicable, Interventional, and Basic science
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.
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:
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →This is the only study on the registry with Lisa Griffin as lead sponsor.
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Exclusion Criteria:
Behavioral: sit-to-stand · Behavioral: stand to sit · Behavioral: standing perturbation · Other: MRI of sciatic nerve
Behavioral: sit-to-stand · Behavioral: stand to sit · Behavioral: standing perturbation · Other: MRI of sciatic nerve
Behavioral: sit-to-stand · Behavioral: stand to sit · Behavioral: standing perturbation · Other: MRI of sciatic nerve
test for balance during movement from sitting to standing
test for balance during movement from standing to sitting
test for balance recovery following perturbation
measure of peripheral nerve diameter
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: First session (immediately after intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: First session (immediately after intervention)
Plan to share: No
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