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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leipzig

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FR-0244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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