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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790229
• Other study ID #: FR-0244
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: June 17, 2019

Study information

• Verified date: June 2019
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Muscle Degeneration

Intervention

Other:
• anti-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.
• standardized physiotherapy
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.

Locations

Country	Name	City	State
Germany	Klinikum St. Georg gGmbH	Leipzig	Saxony
Germany	University Leipzig, Clinic of Orthopedic, Trauma and Plastic Surgery	Leipzig	Saxony

Sponsors (3)

Lead Sponsor	Collaborator
University of Leipzig	Ambulantes Reha Centrum Gruppe, Germany, Hospital St.Georg gGmbH; Clinic of Trauma, Orthopedic and septic Surgery, Leipzig, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (9)

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

Outcome

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