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Effects of Kneehab 12-week Peri-operative Total Knee Arthroplasty

NCT01096524 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-07-21

No results posted yet for this study

Summary

Determine the efficacy of neuromuscular electrical stimulation (NMES, Kneehab) in promoting accelerated recovery of quadriceps function in patients recovering from total knee arthroplasty (TKA) as measured by increases in isometric strength of the knee extensors and scores in the Timed Up and Go (TUG) test.

Conditions

Interventions

OTHER

Standard Physiotherapy

The Control group will complete the standard physiotherapy care pre and post-TKA surgery without NMES.

DEVICE

Kneehab

NMES 2 x 20 minute sessions/day, 5 days/week, 6 weeks pre and 6 weeks post TKA. Kneehab™ (Bio-Medical Research, Ltd., Galway, Ireland) is a NMES device with Multipath™ technology, designed to activate the quadriceps muscle. Kneehab™ is a battery operated, portable, 2-channel cutaneous electrical muscle stimulator, which operates using constant current pulses to stimulate the nerves innervating the quadriceps muscle. Kneehab™, consists of a thigh wrap with anatomically shaped electrodes and a control unit. Electrodes are placed over the quadriceps muscles and the garment is wrapped around the leg above the knee. Brief electrical impulses are delivered through the skin surface adhesive electrodes.

Sponsors & Collaborators

  • Liverpool University Hospitals NHS Foundation Trust

    collaborator OTHER_GOV

  • Bio-Medical Research, Ltd.

    lead INDUSTRY

Principal Investigators

  • Alasdair Santini, M.D. · Royal Liverpool & Broadgreen University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01096524 on ClinicalTrials.gov