Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544876
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Balance Control and Recovery in Diabetes Peripheral Neuropathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Balance Control and Recovery in Diabetes Peripheral Neuropathy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DPN
Brief 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
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 45 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None