Diabetic Peripheral NeuropathyDPNNCT06544876
Balance Control and Recovery in Diabetes Peripheral Neuropathy
A study testing sit-to-stand, stand to sit and standing perturbation in people with Diabetic Peripheral Neuropathy and Diabetic Peripheral Neuropathy Type 2, run by Lisa Griffin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathy Type 2, Diabetic Peripheral Neuropathy Type 2 - Uncontrolled
- What is being tested?
- sit-to-stand, stand to sit and standing perturbation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2023to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type II diabetes with peripheral neuropathy
Who cannot join
- Foot ulcer
- Partial amputation
- Have experience of Stroke
- Painful neuropathy
- Inability to stand or walk independently
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas at Austin
Austin, Texas, 78712
Mohsen Alighanbari, M.Sc., 512-471-9228, m.alighanbari@utexas.edu
Lisa Griffin, Ph.D., 5124712786, l.griffin@austin.utexas.edu
About this study
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.
Read the 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:
- Measures of body weight, height, and limb diameter and measuring including leg length, knee width, elbow width, wrist width, and hand thickness.
- Measures of sensation of the big toe and heel area for both legs.
- Surface sensors will be placed on the leg muscles using non-allergic double adhesive tape.
- Participants will sit down and stand up on a chair with adjustable height.
- 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.
- Finally, muscle strength of the legs' muscles will be collected.
- Conditions
- Diabetic Peripheral Neuropathy, Diabetic Peripheral Neuropathy Type 2, Diabetic Peripheral Neuropathy Type 2 - Uncontrolled, Healthy Aging
- Being tested
- sit-to-stand, stand to sit, standing perturbation, MRI of sciatic nerve
- Keywords
- diabetic peripheral neuropathy, balance, sensation, aging, older adult, foot, sit-to-stand, falls, falling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sit-to-standBehavioural
test for balance during movement from sitting to standing
stand to sitBehavioural
test for balance during movement from standing to sitting
standing perturbationBehavioural
test for balance recovery following perturbation
MRI of sciatic nerveOther
measure of peripheral nerve diameter
| Study group | Role | What they receive |
|---|---|---|
| healthy younger adult | Active comparator | Not described Receives: Behavioral: sit-to-stand; Behavioral: stand to sit; Behavioral: standing perturbation; Other: MRI of sciatic nerve |
| Healthy older adult | Active comparator | Not described Receives: Behavioral: sit-to-stand; Behavioral: stand to sit; Behavioral: standing perturbation; Other: MRI of sciatic nerve |
| older adult with diabetic peripheral neuropathy | Experimental | Not described Receives: Behavioral: sit-to-stand; Behavioral: stand to sit; Behavioral: standing perturbation; Other: MRI of sciatic nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First session (immediately after intervention)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First session (immediately after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start12 Sep 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lisa Griffin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lisa Griffin, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544876
- Sponsor's protocol ID
- STUDY00001512
- Acronym
- DPN
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Control and Recovery in Diabetes Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06544876
- Acronym / sponsor ID
- DPN / STUDY00001512
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lisa GriffinUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Measures of body weight, height, and limb diameter and measuring including leg length, knee width, elbow width, wrist width, and hand thickness.
- Measures of sensation of the big toe and heel area for both legs.
- Surface sensors will be placed on the leg muscles using non-allergic double adhesive tape.
- Participants will sit down and stand up on a chair with adjustable height.
- 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.
- Finally, muscle strength of the legs' muscles will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy younger adult | Active comparator | Behavioral: sit-to-stand, Behavioral: stand to sit, Behavioral: standing perturbation, Other: MRI of sciatic nerve |
| Healthy older adult | Active comparator | Behavioral: sit-to-stand, Behavioral: stand to sit, Behavioral: standing perturbation, Other: MRI of sciatic nerve |
| older adult with diabetic peripheral neuropathy | Experimental | Behavioral: sit-to-stand, Behavioral: stand to sit, Behavioral: standing perturbation, Other: MRI of sciatic nerve |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type II diabetes with peripheral neuropathy
Key exclusion criteria (5 listed)
- Foot ulcer
- Partial amputation
- Have experience of Stroke
- Painful neuropathy
- Inability to stand or walk independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sit-to-standtest for balance during movement from sitting to standing | Behavioural | Healthy older adult, healthy younger adult, older adult with diabetic peripheral neuropathy |
| stand to sittest for balance during movement from standing to sitting | Behavioural | Healthy older adult, healthy younger adult, older adult with diabetic peripheral neuropathy |
| standing perturbationtest for balance recovery following perturbation | Behavioural | Healthy older adult, healthy younger adult, older adult with diabetic peripheral neuropathy |
| MRI of sciatic nervemeasure of peripheral nerve diameter | Other | Healthy older adult, healthy younger adult, older adult with diabetic peripheral neuropathy |
Primary outcome
Center of pressure using force plate
Time frame: First session (immediately after intervention)
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.
Center of mass using Vicon cameras.
Time frame: First session (immediately after intervention)
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.
Joint moment using Nexus software
Time frame: First session (immediately after intervention)
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.
Local dynamic stability using Motek and Vicon system
Time frame: First session (immediately after intervention)
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.
4 secondary outcomes
Muscle amplitude using root mean square
Time frame: First session (immediately after intervention)
Muscle onset time using electromyography
Time frame: First session (immediately after intervention)
Muscle co-activation index using EMG
Time frame: First session (immediately after intervention)
Muscle energy frequency using EMG data
Time frame: First session (immediately after intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sit-to-stand, stand to sit and standing perturbation in people with Diabetic Peripheral Neuropathy and Diabetic Peripheral Neuropathy Type 2, run by Lisa Griffin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of pressure using force plate (time frame: First session (immediately after intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.