Recruiting

Observational Study

Sponsor:

Lisa Griffin

Code:

NCT06544876

Conditions

Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy Type 2

Diabetic Peripheral Neuropathy Type 2 - Uncontrolled

Healthy Aging

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

sit-to-stand

stand to sit

standing perturbation

MRI of sciatic nerve

Study Details

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.

Conditions

Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy Type 2

Diabetic Peripheral Neuropathy Type 2 - Uncontrolled

Healthy Aging

Study ID

NCT06544876

Start date

Sep 12, 2023

Status verified date

Aug, 2024

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Type II diabetes with peripheral neuropathy

Exclusion Criteria:

  • Foot ulcer
  • Partial amputation
  • Have experience of Stroke
  • Painful neuropathy
  • Inability to stand or walk independently

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: healthy younger adult

active comparator: Healthy older adult

experimental: older adult with diabetic peripheral neuropathy

Interventions

sit-to-stand

test for balance during movement from sitting to standing

stand to sit

test for balance during movement from standing to sitting

standing perturbation

test for balance recovery following perturbation

MRI of sciatic nerve

measure of peripheral nerve diameter

Primary outcome measure

  • Center of pressure using force plate [ Time Frame: First session (immediately after intervention) ]
  • Center of mass using Vicon cameras. [ Time Frame: First session (immediately after intervention) ]
  • Joint moment using Nexus software [ Time Frame: First session (immediately after intervention) ]
  • Local dynamic stability using Motek and Vicon system [ Time Frame: First session (immediately after intervention) ]

Central Contacts and Locations

Locations

The University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Mohsen Alighanbari, M.Sc.

512-471-9228m.alighanbari@utexas.edu

Lisa Griffin, Ph.D.

5124712786l.griffin@austin.utexas.edu

More Information

Sponsor

Lisa Griffin

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Keywords

  • diabetic peripheral neuropathy
  • balance
  • sensation
  • aging
  • older adult
  • foot
  • sit-to-stand
  • falls
  • falling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lisa Griffin on 2024-08-09.