Muscle Degeneration Clinical Trial
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
NCT number | NCT02790229 |
Other study ID # | FR-0244 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | June 17, 2019 |
Verified date | June 2019 |
Source | University of Leipzig |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 73 |
Est. completion date | June 17, 2019 |
Est. primary completion date | June 17, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum St. Georg gGmbH | Leipzig | Saxony |
Germany | University Leipzig, Clinic of Orthopedic, Trauma and Plastic Surgery | Leipzig | Saxony |
Lead Sponsor | Collaborator |
---|---|
University of Leipzig | Ambulantes Reha Centrum Gruppe, Germany, Hospital St.Georg gGmbH; Clinic of Trauma, Orthopedic and septic Surgery, Leipzig, Germany |
Germany,
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. Epub 2006 Jun 15. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Suetta C, Frandsen U, Mackey AL, Jensen L, Hvid LG, Bayer ML, Petersson SJ, Schrøder 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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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