Spa Rehabilitation After Cruciate Ligament Injury in Sportsmen (Thermasport)

August 5, 2016 updated by: Central Hospital, Nancy, France

Comparison Between Two Rehabilitation Programs (Conventional and Aquatic) After Cruciate Ligament Injury in Sportsmen

Knee cruciate ligament injury is a common injury (15 000 per year in France) which concerns young sportsmen. Consequences are limitation in physical and sporting activities and at work.

Main objective: to compare water and traditional rehabilitation after cruciate ligament injury reconstruction in terms of kinematics of recovery and of proprioceptive abilities development.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Secondary objectives: to compare algo-functional and sport, social and job come back date between both groups.

Multicentric randomised trial comparing two therapy protocols in knee cruciate ligament injury.

After surgery, 2 weeks rehabilitation; 3 weeks conventional rehabilitation (group 1) or rehabilitation in water (group 2).

Data will be collected at inclusion (before surgery), 2 weeks, 1 month, 2 months and 6 months after surgery.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Lorraine
      • Nancy, Lorraine, France, 54500
        • Recruiting
        • Nancy University Hospital
        • Contact:
        • Principal Investigator:
          • Philippe Perrin, MD, PhD, Prof.
        • Sub-Investigator:
          • Michel Boulangé, MD, PhD, Prof
        • Sub-Investigator:
          • Didier Mainard, MD, PhD, Prof.
        • Sub-Investigator:
          • Nicolas Hummer, MD
        • Sub-Investigator:
          • Nicolas Paris, MD
        • Sub-Investigator:
          • Frank Wein, MD
        • Sub-Investigator:
          • Jean Paysant, MD, PhD, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults,
  • 18-49 years,
  • indication of knee anterior cruciate ligament reconstruction.

Exclusion Criteria:

  • other recent lower limb sprain,
  • history of neurological disease (stroke, central or peripheral degenerative disease),
  • psychtrope or antihypertensive drugs,
  • aquatic activities contra-indication (cutaneous).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual protocol
2 weeks conventional rehabilitation 3 weeks conventional rehabilitation
Other: Usual protocol
Active Comparator: Spa protocol
2 weeks conventional rehabilitation 3 weeks aquatic rehabilitation
Other: Spa protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posturography composite score
Time Frame: up to 6 months
Postural control during quiet stance will be evaluated without and with sensory conflict by a sensory organization test
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (Estimate)

August 26, 2014

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00390-47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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