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

June 18, 2019 updated by: Dr. med. Ralf Henkelmann, University of Leipzig

Outcome of Patients After Lower Limb Fracture With Partial Weight Bearing Postoperatively Treated With or Without Anti-gravity Treadmill (Alter G®) During Six Weeks of Rehabilitation - a Bicentric Prospective Randomized Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • University Leipzig, Clinic of Orthopedic, Trauma and Plastic Surgery
      • Leipzig, Saxony, Germany, 04129
        • Klinikum St. Georg gGmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: anti-gravity treadmill arm
Treatment with anti-gravity treadmill (alter G®)
Other: anti-gravity treadmill (alter G®)
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.
OTHER: control arm
Treatment with standardized physiotherapy
Other: standardized physiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of overall KOOS or FOAS
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the 5 subscores of the KOOS or FAOS
Time Frame: Baseline to 6 and 12 weeks and 12 months
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.
Baseline to 6 and 12 weeks and 12 months
Circumference measurement of tights and lower leg on both legs
Time Frame: Baseline to day of discharge, 3,6 and 12 weeks and 12 months
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.
Baseline to day of discharge, 3,6 and 12 weeks and 12 months
ROM
Time Frame: Baseline to 6 and 12 weeks and 12 months
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.
Baseline to 6 and 12 weeks and 12 months
SF-36
Time Frame: Baseline to 6 and 12 weeks and 12 months
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.
Baseline to 6 and 12 weeks and 12 months
DGI
Time Frame: day of discharge to 3, 6 and 12 weeks and 12 months postoperative
Dynamic gait index (DGI) from day of discharge (7-11d) to 3, 6 and 12 weeks and 12 months after operation determined for each group and between the groups.
day of discharge to 3, 6 and 12 weeks and 12 months postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence from work
Time Frame: 12 months
Number of days of absence from work (employment) and/or days of inability to follow usual activities until FA and time point when patient was back to work and/or to follow usual activities. Data recorded for each group and compared between the groups.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Collaborators

Ambulantes Reha Centrum Gruppe, Germany
Hospital St.Georg gGmbH; Clinic of Trauma, Orthopedic and septic Surgery, Leipzig, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

June 17, 2019

Study Completion (ACTUAL)

June 17, 2019

Study Registration Dates

First Submitted

May 29, 2016

First Submitted That Met QC Criteria

May 29, 2016

First Posted (ESTIMATE)

June 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FR-0244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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