NCT03206398

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

June 30, 2017

Last Update Submit

June 30, 2017

Conditions

Weight-bearingRehabilitation

Outcome Measures

Primary Outcomes (1)

  • standardized gait analysis

    standardized gait analysis was done with fluorescent markers and two cameras

    Day 1 - 40 days

Secondary Outcomes (2)

  • numeric rating scale

    Day 1 - 40 days

  • dynamic gait index

    Day 1 - 40 days

Study Arms (1)

pelvic fracture

OTHER

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

Device: anti-gravity treadmill

Interventions

anti-gravity treadmillDEVICE

anti-gravity treadmill for a total of 40 days in addition to physiotherapy

pelvic fracture

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with non-operatively treated pelvic fractures

You may not qualify if:

  • pregnancy, neuromuscular disorders, preexisting muscle atrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: anti-gravity treadmill for a total of 40 days in addition to physiotherapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 2, 2017

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

July 2, 2017

Record last verified: 2017-06