Clinical trial NCT02790229: Postoperatively Treated Patients With Lower Limb Fracture With or Without an Anti-gravity Treadmill
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Degeneration
Keywords: rehabilitation, anti-gravity treadmill
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Ambulantes Reha Centrum Gruppe, Germany
name: Hospital St.Georg gGmbH; Clinic of Trauma, Orthopedic and septic Surgery, Leipzig, Germany
First posted: 2016-06-03
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of overall KOOS or FOAS
timeFrame: 12 months
Secondary outcomes:
measure: Change of the 5 subscores of the KOOS or FAOS
timeFrame: Baseline to 6 and 12 weeks and 12 months
measure: Circumference measurement of tights and lower leg on both legs
timeFrame: Baseline to day of discharge, 3,6 and 12 weeks and 12 months
measure: ROM
timeFrame: Baseline to 6 and 12 weeks and 12 months
measure: SF-36
timeFrame: Baseline to 6 and 12 weeks and 12 months
measure: DGI
timeFrame: day of discharge to 3, 6 and 12 weeks and 12 months postoperative
Other outcomes:
measure: Absence from work
timeFrame: 12 months
Locations:
city: Leipzig
country: Germany
facility: University Leipzig, Clinic of Orthopedic, Trauma and Plastic Surgery
state: Saxony
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH
state: Saxony
Study officials:
References:
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