Spa Rehabilitation After Cruciate Ligament Injury in Sportsmen

NCT ID: NCT02225613

Last Updated: 2016-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Cruciate Ligament Injury Balance Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Usual protocol

2 weeks conventional rehabilitation 3 weeks conventional rehabilitation

Group Type ACTIVE_COMPARATOR

Usual protocol

Intervention Type OTHER

Spa protocol

2 weeks conventional rehabilitation 3 weeks aquatic rehabilitation

Group Type ACTIVE_COMPARATOR

Spa protocol

Intervention Type OTHER

Interventions

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Usual protocol

Intervention Type OTHER

Spa protocol

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nancy University Hospital

Nancy, Lorraine, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Philippe Perrin, MD, PhD

Role: CONTACT

+333 83 15 49 68

Facility Contacts

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Philippe Perrin, MD, PhD, Prof.

Role: primary

+333 83 15 49 68

References

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Peultier-Celli L, Mainard D, Wein F, Paris N, Boisseau P, Ferry A, Gueguen R, Chary-Valckenaere I, Paysant J, Perrin P. Comparison of an Innovative Rehabilitation, Combining Reduced Conventional Rehabilitation with Balneotherapy, and a Conventional Rehabilitation after Anterior Cruciate Ligament Reconstruction in Athletes. Front Surg. 2017 Nov 7;4:61. doi: 10.3389/fsurg.2017.00061. eCollection 2017.

Reference Type DERIVED
PMID: 29164130 (View on PubMed)

Other Identifiers

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2014-A00390-47

Identifier Type: -

Identifier Source: org_study_id

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