NCT02225613

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

August 25, 2014

Last Update Submit

August 5, 2016

Conditions

Cruciate Ligament InjuryBalance Control

Keywords

Cruciate ligament injuryBalance controlRehabilitationSpa therapySport

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Usual protocol

ACTIVE COMPARATOR

2 weeks conventional rehabilitation 3 weeks conventional rehabilitation

Other: Usual protocol

Spa protocol

ACTIVE COMPARATOR

2 weeks conventional rehabilitation 3 weeks aquatic rehabilitation

Other: Spa protocol

Interventions

Usual protocolOTHER
Usual protocol
Spa protocolOTHER
Spa protocol

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nancy University Hospital

Nancy, Lorraine, 54500, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29164130DERIVED

Central Study Contacts

Philippe Perrin, MD, PhD

CONTACT

+333 83 15 49 68philippe.perrin@univ-lorraine.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

August 26, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2017

Study Completion

October 1, 2017

Last Updated

August 8, 2016

Record last verified: 2016-08

Locations

FR(1)