CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Hybrid Training using Electrodes and Joint Motion Sensors +1 moredevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02802878
NCT02802878N/ACompleted

Determining the Effects of the Combined Application of Electrical Stimulation and Volitional Contractions on Muscle Strength and Knee Pain and Function in Women With or at Risk for Knee Osteoarthritis

University of Kansas Medical Center·interventional·Posted Jun 16, 2016·Updated May 18, 2018

In Brief

A clinical study evaluating Hybrid Training using Electrodes and Joint Motion Sensors and Isokinetic Training with Isokinetic Dynamometer for Knee Osteoarthritis. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the efficacy of a 12-week low-load neuromuscular electrical stimulation with volitional contraction (NMES-VC) training program to improve quadriceps strength and activation, while not adversely affecting knee-related pain, activities of daily living or quality of life in women with knee pain. The primary outcome will be change in maximal isokinetic knee extensor torque. The investigators will test the following hypotheses. In comparison with low-load (40%) resistance training without electrical stimulation, a 12-week NMES-VC training program will: Hypothesis 1: Increase maximal isokinetic knee extensor torque Secondary questions and response variables Hypothesis 2: Not adversely affect knee pain or quality of life, assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire Additional hypotheses in women with risk factors for incident symptomatic or progressive KOA: 1. Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases quadriceps muscle rate of force development 2. Determine the extent to which NMES-VC enhanced low-intensity exercise is tolerated (using numeric rating scale survey "level of pain you experienced during the hybrid training or 40% isokinetic exercise") 3. Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases physical function (20m walk, chair stand)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsKurume University

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 16, 2016
Enrollment StartJun 1, 2016
Primary CompletionDec 14, 2016
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.0 years ago

Interventions

Hybrid Training using Electrodes and Joint Motion Sensorsdevice

Electrodes (Sekisui Plastics Co., Tokyo, Japan) will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and on the posterior thigh over the motor points of the medial and lateral hamstrings. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor (Mutoh Engineering Inc., Tokyo, Japan) will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group.

Isokinetic Training with Isokinetic Dynamometerdevice

Low intensity exercises completed using isokinetic dynamometer (HUMAC NORM, Computer Sports Medicine Inc. (CSMi), Stoughton, MA) in isokinetic mode at approximately 40%1 RM.