Skip to main content
OpenTrials
Completed

NCT Number: NCT02790229

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Muscle Degeneration

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum St. Georg gGmbH, Leipzig, Saxony, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Change of overall KOOS or FOAS

    Time frame: 12 months

    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.

Secondary outcomes

  1. Change of the 5 subscores of the KOOS or FAOS

    Time frame: Baseline to 6 and 12 weeks and 12 months

    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.

  2. Circumference measurement of tights and lower leg on both legs

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

    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.

  3. ROM

    Time frame: Baseline to 6 and 12 weeks and 12 months

    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.

  4. SF-36

    Time frame: Baseline to 6 and 12 weeks and 12 months

    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.

  5. DGI

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

    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.

Other outcomes

  1. Absence from work

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 3, 2016
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.