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L'essai clinique NCT06544876 (DPN) pour Neuropathie périphérique diabétique, Diabetic Peripheral Neuropathy TYPE 2, Diabetic Peripheral Neuropathy TYPE 2 - Uncontrolled, Vieillissement en bonne santé est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Balance Control and Recovery in Diabetes Peripheral Neuropathy (DPN)

En recrutement
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L'étude clinique NCT06544876 (DPN) est un essai interventionnel pour Neuropathie périphérique diabétique, Diabetic Peripheral Neuropathy TYPE 2, Diabetic Peripheral Neuropathy TYPE 2 - Uncontrolled, Vieillissement en bonne santé. Son statut actuel est : en recrutement. L'étude a débuté le 12 septembre 2023 et vise à recruter 60 participants. Dirigé par Lisa Griffin, l'essai devrait être terminé d'ici le 31 août 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 9 août 2024.
Résumé succinct
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.

Description détaillée

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. 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.
Titre officiel

Balance Control and Recovery in Diabetes Peripheral Neuropathy

Conditions
Neuropathie périphérique diabétiqueDiabetic Peripheral Neuropathy TYPE 2Diabetic Peripheral Neuropathy TYPE 2 - UncontrolledVieillissement en bonne santé
Autres identifiants de l'essai
  • DPN
  • STUDY00001512
Numéro NCT
Date de début (réel)
2023-09-12
Dernière mise à jour publiée
2024-08-09
Date de fin (estimée)
2028-08-31
Inscription (estimée)
60
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
diabetic peripheral neuropathy
balance
sensation
aging
older adult
foot
sit-to-stand
falls
falling
Objectif principal
Recherche fondamentale
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur actifhealthy younger adult
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
Comparateur actifHealthy older adult
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
Expérimentalolder adult with diabetic peripheral neuropathy
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
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
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.
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.
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.
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.
First session (immediately after intervention)
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
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.
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.
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.
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.
First session (immediately after intervention)
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
50 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
  • Type II diabetes with peripheral neuropathy

  • Foot ulcer
  • Partial amputation
  • Have experience of Stroke
  • Painful neuropathy
  • Inability to stand or walk independently
Lisa Griffin logoLisa Griffin
Partie responsable de l'essai
Lisa Griffin, Promoteur-Investigateur, Associate Professor, University of Texas at Austin
Aucune donnée de contact disponible
1 Centres de l'essai dans 1 pays

Texas

The University of Texas at Austin, Austin, Texas, 78712, United States
Mohsen Alighanbari, M.Sc., Contact, 512-471-9228, [email protected]
Lisa Griffin, Ph.D., Contact, 5124712786, [email protected]
En recrutement