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

Primary Purpose

Weight-bearing, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
anti-gravity treadmill
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight-bearing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with non-operatively treated pelvic fractures

Exclusion Criteria:

  • pregnancy, neuromuscular disorders, preexisting muscle atrophy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    pelvic fracture

    Arm Description

    patients with pelvic fracture will additionally be treated with anti-gravity treadmill

    Outcomes

    Primary Outcome Measures

    standardized gait analysis
    standardized gait analysis was done with fluorescent markers and two cameras

    Secondary Outcome Measures

    numeric rating scale
    numeric rating scale (NRS) to evaluate pain
    dynamic gait index
    rated gait index validated

    Full Information

    First Posted
    June 30, 2017
    Last Updated
    June 30, 2017
    Sponsor
    University of Leipzig
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03206398
    Brief Title
    Influence of an Anti-gravity Treadmill on Functional Outcome in Non-operatively Treated Pelvic Fractures - a Pilot Study
    Official Title
    Influence of an Anti-gravity Treadmill on Functional Outcome in Non-operatively Treated Pelvic Fractures - a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2015 (Actual)
    Primary Completion Date
    December 1, 2015 (Actual)
    Study Completion Date
    February 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Leipzig

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight-bearing, Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    anti-gravity treadmill for a total of 40 days in addition to physiotherapy
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pelvic fracture
    Arm Type
    Other
    Arm Description
    patients with pelvic fracture will additionally be treated with anti-gravity treadmill
    Intervention Type
    Device
    Intervention Name(s)
    anti-gravity treadmill
    Intervention Description
    anti-gravity treadmill for a total of 40 days in addition to physiotherapy
    Primary Outcome Measure Information:
    Title
    standardized gait analysis
    Description
    standardized gait analysis was done with fluorescent markers and two cameras
    Time Frame
    Day 1 - 40 days
    Secondary Outcome Measure Information:
    Title
    numeric rating scale
    Description
    numeric rating scale (NRS) to evaluate pain
    Time Frame
    Day 1 - 40 days
    Title
    dynamic gait index
    Description
    rated gait index validated
    Time Frame
    Day 1 - 40 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients with non-operatively treated pelvic fractures Exclusion Criteria: pregnancy, neuromuscular disorders, preexisting muscle atrophy

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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