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

NCT02790229 | Completed DMC

• 1 other identifier: FR-0244
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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.

Conditions

Muscle Degeneration

Keywords

rehabilitation, anti-gravity treadmill

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of the 5 subscores of the KOOS or FAOS

  Baseline to 6 and 12 weeks and 12 months

• Circumference measurement of tights and lower leg on both legs

  Baseline to day of discharge, 3,6 and 12 weeks and 12 months

• ROM

  Baseline to 6 and 12 weeks and 12 months

• SF-36

  Baseline to 6 and 12 weeks and 12 months

• DGI

  day of discharge to 3, 6 and 12 weeks and 12 months postoperative

Other Outcomes (1)

• Absence from work

  12 months

Study Arms (2)

anti-gravity treadmill arm

EXPERIMENTAL

Treatment with anti-gravity treadmill (alter G®)

Other: anti-gravity treadmill (alter G®)

control arm

OTHER

Treatment with standardized physiotherapy

Other: standardized physiotherapy

Interventions

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.

anti-gravity treadmill arm

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.

control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with a postoperative partial weight bearing after tibial plateau or ankle fracture.
• man and woman of an age between 18 and 65

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leipzig: lead
• Ambulantes Reha Centrum Gruppe, Germany: collaborator
• Hospital St.Georg gGmbH; Clinic of Trauma, Orthopedic and septic Surgery, Leipzig, Germany: collaborator

Study Sites (2)

University Leipzig, Clinic of Orthopedic, Trauma and Plastic Surgery

Leipzig, Saxony, 04103, Germany

Location

Klinikum St. Georg gGmbH

Leipzig, Saxony, 04129, Germany

Location

Related Publications (10)

• 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.

  PMID: 24362964 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.

  PMID: 23732643 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.

  PMID: 21703879 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.

  PMID: 21584484 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.

  PMID: 25647537 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.

  PMID: 20434621 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.

  PMID: 25226319 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.

  PMID: 21621673 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.

  PMID: 16777997 BACKGROUND

• 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.

  PMID: 28288613 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Ralf Henkelmann

Study Record Dates

• First Submitted: May 29, 2016
• First Posted: June 3, 2016
• Study Start: August 1, 2016
• Primary Completion: June 17, 2019
• Study Completion: June 17, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)