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Spa Rehabilitation After Cruciate Ligament Injury in Sportsmen (Thermasport)

Primary Purpose

Cruciate Ligament Injury, Balance Control

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Usual protocol

Spa protocol

About this trial

This is an interventional treatment trial for Cruciate Ligament Injury focused on measuring Cruciate ligament injury, Balance control, Rehabilitation, Spa therapy, Sport

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Nancy University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Usual protocol

Spa protocol

Arm Description

2 weeks conventional rehabilitation 3 weeks conventional rehabilitation

2 weeks conventional rehabilitation 3 weeks aquatic rehabilitation

Outcomes

Primary Outcome Measures

Posturography composite score

Postural control during quiet stance will be evaluated without and with sensory conflict by a sensory organization test

Secondary Outcome Measures

Full Information

NCT ID

NCT02225613

First Posted

August 25, 2014

Last Updated

August 5, 2016

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT02225613

Brief Title

Spa Rehabilitation After Cruciate Ligament Injury in Sportsmen

Acronym

Thermasport

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

March 2017 (Anticipated)

Study Completion Date

October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cruciate Ligament Injury, Balance Control

Keywords

Cruciate ligament injury, Balance control, Rehabilitation, Spa therapy, Sport

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual protocol

Arm Type

Active Comparator

Arm Description

2 weeks conventional rehabilitation 3 weeks conventional rehabilitation

Arm Title

Spa protocol

Arm Type

Active Comparator

Arm Description

2 weeks conventional rehabilitation 3 weeks aquatic rehabilitation

Intervention Type

Other

Intervention Name(s)

Usual protocol

Intervention Type

Other

Intervention Name(s)

Spa protocol

Primary Outcome Measure Information:

Title

Posturography composite score

Description

Postural control during quiet stance will be evaluated without and with sensory conflict by a sensory organization test

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Philippe Perrin, MD, PhD

Phone

+333 83 15 49 68

philippe.perrin@univ-lorraine.fr

Facility Information:

Facility Name

Nancy University Hospital

City

Nancy

State/Province

Lorraine

ZIP/Postal Code

54500

Country

France

Individual Site Status

Recruiting

Facility Contact: