Postoperatively Treated Patients With Lower Limb Fracture With or Without an Anti-gravity Treadmill

Not Applicable

Completed

• Conditions: Muscle Degeneration
• Interventions: Other: anti-gravity treadmill (alter G®); Other: standardized physiotherapy

• Registration Number: NCT02790229
• Lead Sponsor: University of Leipzig

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-29
• Study First Submitted QC: 2016-05-29
• Study First Posted: 2016-06-03
• Study Start: 2016-08
• Status Verified: 2019-06
• Primary Completion: 2019-06-17
• Study Completion: 2019-06-17
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anti-gravity treadmill arm	anti-gravity treadmill (alter G®)	Treatment with anti-gravity treadmill (alter G®)
control arm	standardized physiotherapy	Treatment with standardized physiotherapy

Primary Outcome Measures

Name	Time	Method
Change of overall KOOS or FOAS	12 months	Change of overall KOOS (Knee Injury and Osteoarthritis Outcome Score) or FOAS (Foot and Ankle Outcome Score) from baseline (Day 1 after operation) to Final Assessment (FA) 12 months after operation determined for each group and between the groups.

Secondary Outcome Measures

Name	Time	Method
Change of the 5 subscores of the KOOS or FAOS	Baseline to 6 and 12 weeks and 12 months	Change of the 5 subscores of the KOOS or FAOS (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec), knee/ankle related Quality of life (QoL)) determined for each group and between the groups.
Circumference measurement of tights and lower leg on both legs	Baseline to day of discharge, 3,6 and 12 weeks and 12 months	Circumference measurement of tights and lower leg on both legs 10cm and 20cm above the knee joint space and 10cm below (knee in neutral position) from baseline (Day 1 after operation) to day of discharge (7-11d), 3, 6 and 12 weeks and 12 months (FA) after operation determined for each group and between the groups.
ROM	Baseline to 6 and 12 weeks and 12 months	Range of motion (ROM) of the affected joint determined by neutral zero method from baseline (Day 1 after operation) to 6 and 12 weeks and 12 months after operation determined for each group and between the groups.
SF-36	Baseline to 6 and 12 weeks and 12 months	Short Form Health Survey (SF-36) from baseline (Day 1 after operation) to 6 and 12 weeks and 12 months after operation determined for each group and between the groups.
DGI	day of discharge to 3, 6 and 12 weeks and 12 months postoperative	Dynamic gait index (DGI) from day of discharge (7-11d) to 3, 6 and 12 weeks and 12 months after operation determined for each group and between the groups.

Trial Locations

Locations (2)

Klinikum St. Georg gGmbH; 🇩🇪 Leipzig, Saxony, Germany

University Leipzig, Clinic of Orthopedic, Trauma and Plastic Surgery; 🇩🇪 Leipzig, Saxony, Germany