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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03206398
Other study ID # 1007
Secondary ID
Status Completed
Phase N/A
First received June 30, 2017
Last updated June 30, 2017
Start date May 1, 2015
Est. completion date February 1, 2016

Study information

Verified date June 2017
Source University of Leipzig
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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, alterGĀ®, 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)


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date February 1, 2016
Est. primary completion date December 1, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- patients with non-operatively treated pelvic fractures

Exclusion Criteria:

- pregnancy, neuromuscular disorders, preexisting muscle atrophy

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Leipzig

Outcome

Type Measure Description Time frame Safety issue
Primary standardized gait analysis standardized gait analysis was done with fluorescent markers and two cameras Day 1 - 40 days
Secondary numeric rating scale numeric rating scale (NRS) to evaluate pain Day 1 - 40 days
Secondary dynamic gait index rated gait index validated Day 1 - 40 days
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