Single-joint hybrid assistive limb as a new therapeutic device for active-assistive muscle activity-guided rehabilitation of knee joint injury-a randomized controlled clinical trial.

Phase 2

• Conditions: Primary knee TEPFractures near the knee jointKnee ligaments/tendon injuries; M17; S83; S72.4; S82.1; Gonarthrosis [arthrosis of knee]; Dislocation, sprain and strain of joints and ligaments of knee; Fracture of lower end of femur; Fracture of upper end of tibia

• Registration Number: DRKS00031324
• Lead Sponsor: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

implantation of primary knee TEP, performance of KSR or BGSW
-Surgery after fractures close to the knee joint, KSR or BGSW performed
-Surgery after knee ligament/tendon injuries, performance of KSR or BGSW

Exclusion Criteria

-American Society of Anesthesiologists (ASA)-Score > III (classification
for the physical status of the patient)
-Neurological deficits
-Patients with pacemakers
-Skin diseases that are aggravated by sticking of the electrodes
are
-Extensive edema of the lower extremity
-patients with severe pain that makes conventional rehabilitation impossible
rehabilitation impossible
-Rejection by patients

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survey of knee joint range of motion, strength (extension/flexion) after 3 weeks, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Survey Visual Analgesia Scale, lower extremity circumferences, Oxford Knee Score, EQ5D at 3 weeks, 6 and 12 months.