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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Muscle Degeneration

Intervention / Treatment
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* Other: anti-gravity treadmill (alter G®)
* Other: standardized physiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-gravity treadmill arm<br>Treatment with anti-gravity treadmill (alter G®) | Other: anti-gravity treadmill (alter G®)<br>* Patients in the experimental arm will be treated with manual lymphatic drainage, cryotherapy and a fixed protocol of training in an anti-gravity treadmill (alter G®). The protocol is designed parallel to standard physiotherapy with a frequency of two to three times a week with duration of about 20 minutes for six weeks.<br>|
| Other: control arm<br>Treatment with standardized physiotherapy | Other: standardized physiotherapy<br>* Patients in the control arm will be treated with manual lymphatic drainage, cryotherapy and 20 minutes of physiotherapy two to three times a week for six weeks. Physiotherapy will be done according to a standardized protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of overall KOOS or FOAS | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the 5 subscores of the KOOS or FAOS | 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. | Baseline to 6 and 12 weeks and 12 months | 
| Circumference measurement of tights and lower leg on both legs | 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. | Baseline to day of discharge, 3,6 and 12 weeks and 12 months | 
| ROM | 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. | Baseline to 6 and 12 weeks and 12 months | 
| SF-36 | 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. | Baseline to 6 and 12 weeks and 12 months | 
| DGI | 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. | day of discharge to 3, 6 and 12 weeks and 12 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, anti-gravity treadmill