Cruciate Ligament InjuryThermasportNCT02225613
Spa Rehabilitation After Cruciate Ligament Injury in Sportsmen
A study testing Usual protocol and Spa protocol in people with Cruciate Ligament Injury and Balance Control, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Cruciate Ligament Injury, Balance Control
- What is being tested?
- Usual protocol and Spa protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults,
- 18-49 years,
- indication of knee anterior cruciate ligament reconstruction.
Who cannot join
- other recent lower limb sprain,
- history of neurological disease (stroke, central or peripheral degenerative disease),
- psychtrope or antihypertensive drugs,
- aquatic activities contra-indication (cutaneous).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nancy University Hospital
Nancy, Lorraine, 54500
Philippe Perrin, MD, PhD, Prof., +333 83 15 49 68, philippe.perrin@univ-lorraine.fr
Philippe Perrin, MD, PhD, Prof.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cruciate Ligament Injury, Balance Control
- Being tested
- Usual protocol, Spa protocol
- Keywords
- Cruciate ligament injury, Balance control, Rehabilitation, Spa therapy, Sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual protocolOther
Spa protocolOther
| Study group | Role | What they receive |
|---|---|---|
| Usual protocol | Active comparator | 2 weeks conventional rehabilitation 3 weeks conventional rehabilitation Receives: Other: Usual protocol |
| Spa protocol | Active comparator | 2 weeks conventional rehabilitation 3 weeks aquatic rehabilitation Receives: Other: Spa protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posturography composite score
Postural control during quiet stance will be evaluated without and with sensory conflict by a sensory organization test
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225613
- Sponsor's protocol ID
- 2014-A00390-47
- Acronym
- Thermasport
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2014
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29164130
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Rehabilitation Programs (Conventional and Aquatic) After Cruciate Ligament Injury in Sportsmen
- ClinicalTrials.gov ID
- NCT02225613
- Acronym / sponsor ID
- Thermasport / 2014-A00390-47
- Conditions
- Cruciate Ligament Injury, Balance Control
- Keywords
- Cruciate ligament injury, Balance control, Rehabilitation, Spa therapy, Sport
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual protocol | Active comparator | Other: Usual protocol2 weeks conventional rehabilitation 3 weeks conventional rehabilitation |
| Spa protocol | Active comparator | Other: Spa protocol2 weeks conventional rehabilitation 3 weeks aquatic rehabilitation |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults,
- 18-49 years,
- indication of knee anterior cruciate ligament reconstruction.
Key exclusion criteria (4 listed)
- other recent lower limb sprain,
- history of neurological disease (stroke, central or peripheral degenerative disease),
- psychtrope or antihypertensive drugs,
- aquatic activities contra-indication (cutaneous).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual protocol | Other | Usual protocol |
| Spa protocol | Other | Spa protocol |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Derived from this study: PubMed 29164130Peultier-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual protocol and Spa protocol in people with Cruciate Ligament Injury and Balance Control, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Perrin, MD, PhD (+333 83 15 49 68, philippe.perrin@univ-lorraine.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posturography composite score (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02225613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.