Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ambulantes Reha Centrum Gruppe, Germany | UNKNOWN |
| Hospital St.Georg gGmbH; Clinic of Trauma, Orthopedic and septic Surgery, Leipzig, Germany | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-gravity treadmill arm | Experimental | Treatment with anti-gravity treadmill (alter G®) |
|
| control arm | Other | Treatment with standardized physiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-gravity treadmill (alter G®) | Other | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Absence from work | 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. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Leipzig, Clinic of Orthopedic, Trauma and Plastic Surgery | Leipzig | Saxony | 04103 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24362964 | Background | Webber SC, Horvey KJ, Yurach Pikaluk MT, Butcher SJ. Cardiovascular responses in older adults with total knee arthroplasty at rest and with exercise on a positive pressure treadmill. Eur J Appl Physiol. 2014 Mar;114(3):653-62. doi: 10.1007/s00421-013-2798-1. Epub 2013 Dec 22. | |
| 23732643 | Background | Suetta C, Frandsen U, Mackey AL, Jensen L, Hvid LG, Bayer ML, Petersson SJ, Schroder HD, Andersen JL, Aagaard P, Schjerling P, Kjaer M. Ageing is associated with diminished muscle re-growth and myogenic precursor cell expansion early after immobility-induced atrophy in human skeletal muscle. J Physiol. 2013 Aug 1;591(15):3789-804. doi: 10.1113/jphysiol.2013.257121. Epub 2013 Jun 3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| standardized physiotherapy | Other | 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. |
|
| 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 |
| Klinikum St. Georg gGmbH |
| Leipzig |
| Saxony |
| 04129 |
| Germany |
| 21703879 | Background | Saxena A, Granot A. Use of an anti-gravity treadmill in the rehabilitation of the operated achilles tendon: a pilot study. J Foot Ankle Surg. 2011 Sep-Oct;50(5):558-61. doi: 10.1053/j.jfas.2011.04.045. Epub 2011 Jun 23. |
| 21584484 | Background | Takacs J, Leiter JR, Peeler JD. Novel application of lower body positive-pressure in the rehabilitation of an individual with multiple lower extremity fractures. J Rehabil Med. 2011 Jun;43(7):653-6. doi: 10.2340/16501977-0806. |
| 25647537 | Background | Peeler J, Christian M, Cooper J, Leiter J, MacDonald P. Managing Knee Osteoarthritis: The Effects of Body Weight Supported Physical Activity on Joint Pain, Function, and Thigh Muscle Strength. Clin J Sport Med. 2015 Nov;25(6):518-23. doi: 10.1097/JSM.0000000000000173. |
| 20434621 | Background | Moore MN, Vandenakker-Albanese C, Hoffman MD. Use of partial body-weight support for aggressive return to running after lumbar disk herniation: a case report. Arch Phys Med Rehabil. 2010 May;91(5):803-5. doi: 10.1016/j.apmr.2010.01.014. |
| 25226319 | Background | McNeill DK, de Heer HD, Bounds RG, Coast JR. Accuracy of unloading with the anti-gravity treadmill. J Strength Cond Res. 2015 Mar;29(3):863-8. doi: 10.1519/JSC.0000000000000678. |
| 21621673 | Background | Hoffman MD, Donaghe HE. Physiological responses to body weight--supported treadmill exercise in healthy adults. Arch Phys Med Rehabil. 2011 Jun;92(6):960-6. doi: 10.1016/j.apmr.2010.12.035. |
| 16777997 | Background | Cutuk A, Groppo ER, Quigley EJ, White KW, Pedowitz RA, Hargens AR. Ambulation in simulated fractional gravity using lower body positive pressure: cardiovascular safety and gait analyses. J Appl Physiol (1985). 2006 Sep;101(3):771-7. doi: 10.1152/japplphysiol.00644.2005. Epub 2006 Jun 15. |
| 28288613 | Derived | Henkelmann R, Schneider S, Muller D, Gahr R, Josten C, Bohme J. Outcome of patients after lower limb fracture with partial weight bearing postoperatively treated with or without anti-gravity treadmill (alter G(R)) during six weeks of rehabilitation - a protocol of a prospective randomized trial. BMC Musculoskelet Disord. 2017 Mar 14;18(1):104. doi: 10.1186/s12891-017-1461-0. |