Muscle Degeneration
Conditions
Keywords
rehabilitation, anti-gravity treadmill
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.
Interventions
OTHERanti-gravity treadmill (alter G®)
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.
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.
Sponsors
Ambulantes Reha Centrum Gruppe, Germany
Hospital St.Georg gGmbH; Clinic of Trauma, Orthopedic and septic Surgery, Leipzig, Germany
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Absence from work | 12 months | Number of days of absence from work (employment) and/or days of inability to follow usual activities until FA and time point when patient was back to work and/or to follow usual activities. Data recorded for each group and compared between the groups. |
Countries
Germany
Outcome results
None listed