Influence of an Anti-gravity Treadmill on Functional Outcome in Non-operatively Treated Pelvic Fractures - a Pilot Study

June 30, 2017 updated by: Dr. med. Ralf Henkelmann, University of Leipzig
Non-operative treatment of pelvic fractures is possible. Immobilisation implies different adjustment processes. Patients with pelvic ring fractures and partial weight bearing have to obtain theses. The aim of this pilot study was to prove the additional effect of the anti-gravity treadmill in patients with non-operatively treated pelvic fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We prospectively included patients with non-operatively treated pelvic fractures as the intervention group (IG) and healthy volunteers of different age, sex and body mass index (BMI) as the reference group (RG).

Patients of the IG participated in a training session every three days with an anti-gravity treadmill (Picture 1, alterG®, www.alterg.com) for a total of 40 days in addition to physiotherapy, lymph drainage massage and manual therapy.

Patients were evaluated on three successive dates: Baseline (S1), after mobilization without crutches with full weight-bearing (20 days, S2) and after 40 days (S3)

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with non-operatively treated pelvic fractures

Exclusion Criteria:

  • pregnancy, neuromuscular disorders, 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: pelvic fracture
patients with pelvic fracture will additionally be treated with anti-gravity treadmill
Device: anti-gravity treadmill
anti-gravity treadmill for a total of 40 days in addition to physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
standardized gait analysis
Time Frame: Day 1 - 40 days
standardized gait analysis was done with fluorescent markers and two cameras
Day 1 - 40 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numeric rating scale
Time Frame: Day 1 - 40 days
numeric rating scale (NRS) to evaluate pain
Day 1 - 40 days
dynamic gait index
Time Frame: Day 1 - 40 days
rated gait index validated
Day 1 - 40 days

Collaborators and Investigators

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

Sponsor

University of Leipzig

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 (Actual)

May 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

June 30, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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