Postoperatively Treated Patients With Lower Limb Fracture With or Without an Anti-gravity Treadmill

University of Leipzig73 enrolled

Overview

The presented study is designed to prove efficacy of the anti-gravity treadmill (alter G®) compared to a standard rehabilitation protocol in patients with tibial plateau or ankle fractures with six weeks of partial weight bearing.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Muscle Degeneration

Interventions

anti-gravity treadmill (alter G®)OTHER

Patients in the experimental arm will be treated with manual lymphatic drainage, cryotherapy and a fixed protocol of training in an anti-gravity treadmill (alter G®). The protocol is designed parallel to standard physiotherapy with a frequency of two to three times a week with duration of about 20 minutes for six weeks.

standardized physiotherapyOTHER

Patients in the control arm will be treated with manual lymphatic drainage, cryotherapy and 20 minutes of physiotherapy two to three times a week for six weeks. Physiotherapy will be done according to a standardized protocol.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with a postoperative partial weight bearing after tibial plateau or ankle fracture. * man and woman of an age between 18 and 65 Exclusion Criteria: * Body weight more than 100kg * serious illness or poor general health as judged by physician that may influence the rehabilitation * open fractures (\>1° according to Gustilo and Anderson) * surgical site infection * pregnancy * neuromuscular disorders or preexisting muscle atrophy.

Locations (2)

University Leipzig, Clinic of Orthopedic, Trauma and Plastic Surgery

Leipzig, Saxony, Germany

Klinikum St. Georg gGmbH

Leipzig, Saxony, Germany

Outcomes

Primary Outcomes

Change of overall KOOS or FOAS

Change of overall KOOS (Knee Injury and Osteoarthritis Outcome Score) or FOAS (Foot and Ankle Outcome Score) from baseline (Day 1 after operation) to Final Assessment (FA) 12 months after operation determined for each group and between the groups.

Time frame: 12 months

Secondary Outcomes

Change of the 5 subscores of the KOOS or FAOS

Change of the 5 subscores of the KOOS or FAOS (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec), knee/ankle related Quality of life (QoL)) determined for each group and between the groups.

Time frame: Baseline to 6 and 12 weeks and 12 months

Circumference measurement of tights and lower leg on both legs

Circumference measurement of tights and lower leg on both legs 10cm and 20cm above the knee joint space and 10cm below (knee in neutral position) from baseline (Day 1 after operation) to day of discharge (7-11d), 3, 6 and 12 weeks and 12 months (FA) after operation determined for each group and between the groups.

Time frame: Baseline to day of discharge, 3,6 and 12 weeks and 12 months

ROM

Range of motion (ROM) of the affected joint determined by neutral zero method from baseline (Day 1 after operation) to 6 and 12 weeks and 12 months after operation determined for each group and between the groups.

Time frame: Baseline to 6 and 12 weeks and 12 months

SF-36

Short Form Health Survey (SF-36) from baseline (Day 1 after operation) to 6 and 12 weeks and 12 months after operation determined for each group and between the groups.

Time frame: Baseline to 6 and 12 weeks and 12 months

DGI

Data from ClinicalTrials.gov

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