Balance Control and Recovery in Diabetes Peripheral Neuropathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-99
SponsorLisa Griffin

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Type II diabetes with peripheral neuropathy

Disqualifiers

Foot ulcer

Partial amputation

Have experience of Stroke

Painful neuropathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • sit-to-stand

    Behavioral

    test for balance during movement from sitting to standing

  • stand to sit

    Behavioral

    test for balance during movement from standing to sitting

  • standing perturbation

    Behavioral

    test for balance recovery following perturbation

  • MRI of sciatic nerve

    Other intervention

    measure of peripheral nerve diameter

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: healthy younger adultActive comparator 4 interventions
Group B: Healthy older adultActive comparator 4 interventions
Group C: older adult with diabetic peripheral neuropathyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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)
4

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lisa Griffin

Lead sponsor

University of Texas at Austin

Sponsor institution