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Muscle DegenerationNCT02790229

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

A study testing anti-gravity treadmill (alter G®) and standardized physiotherapy in people with Muscle Degeneration, run by University of Leipzig at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Muscle Degeneration
What is being tested?
anti-gravity treadmill (alter G®) and standardized physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
2 sitesGermany
Study dates
Aug 2016to 17 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • University Leipzig, Clinic of Orthopedic, Trauma and Plastic Surgery

    Leipzig, Saxony, 04103

  • Klinikum St. Georg gGmbH

    Leipzig, Saxony, 04129

Other trials in Germany

About this study

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

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.

Being tested
anti-gravity treadmill (alter G®), standardized physiotherapy
Keywords
rehabilitation, anti-gravity treadmill

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • standardized physiotherapyOther

    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.

Study groups in NCT02790229
Study groupRoleWhat they receive
anti-gravity treadmill armExperimentalTreatment with anti-gravity treadmill (alter G®)
Receives: Other: anti-gravity treadmill (alter G®)
control armOtherTreatment with standardized physiotherapy
Receives: Other: standardized physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (5)

  1. 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.

    Measured: Baseline to 6 and 12 weeks and 12 months

  2. 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.

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

  3. 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.

    Measured: Baseline to 6 and 12 weeks and 12 months

  4. 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.

    Measured: Baseline to 6 and 12 weeks and 12 months

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion17 Jun 2019
  4. Study completion17 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02790229
Sponsor's protocol ID
FR-0244
Status last verified
Jun 2019
First submitted
29 May 2016
Last updated
20 Jun 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 24362964

  • 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.

    PubMed 23732643

  • 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.

    PubMed 21703879

  • 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.

    PubMed 21584484

  • 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.

    PubMed 25647537

  • 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.

    PubMed 20434621

  • 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.

    PubMed 25226319

  • 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.

    PubMed 21621673

  • 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.

    PubMed 16777997

  • 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.

    PubMed 28288613

Questions about this trial

What is this clinical trial studying?

A study testing anti-gravity treadmill (alter G®) and standardized physiotherapy in people with Muscle Degeneration, run by University of Leipzig at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of overall KOOS or FOAS (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02790229, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.

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