Spa Rehabilitation After Cruciate Ligament Injury in Sportsmen

Balance Control Clinical Trial

— Thermasport  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02225613
• Other study ID #: 2014-A00390-47
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2014
• Last updated: August 5, 2016
• Start date: October 2014
• Est. completion date: October 2017

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: Philippe Perrin, MD, PhD
• Phone: +333 83 15 49 68
• Email: philippe.perrin[@]univ-lorraine.fr
• Is FDA regulated: No
• Health authority: France: ANSM - Agence Nationale de Sécurité du Médicament et des Produits de Santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: October 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Balance Control
• Cruciate Ligament Injury
• Wounds and Injuries

Intervention

Other:
• Usual protocol

• Spa protocol

Locations

Country	Name	City	State
France	Nancy University Hospital	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posturography composite score	Postural control during quiet stance will be evaluated without and with sensory conflict by a sensory organization test	up to 6 months	No