Knee SurgeryLOARALNCT03856983
Benefits of Observing Point-light Displays in Postoperative Rehabilitation of the Total Knee Prosthesis.
A study testing Point light display in people with Knee Surgery and Rehabilitation, run by Poitiers University Hospital at 1 site in France.
Trial summary
The LOARAL project concerns patients who have undergone total knee arthroplasty to treat symptomatic osteoarthritis. Patient will be divided into two groups: a control group where patients will do standard rehabilitation and an experimental group where patients will do standard rehabilitation associated with the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Surgery, Rehabilitation, Point Light Display
- What is being tested?
- Point light display
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2020to 25 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers over 18 years of age who have undergone knee surgery
Who cannot join
- Any locomotor condition not due to knee surgery
- Uncorrected visual disturbances
- Comorbidity altering locomotion (history of stroke, neurological condition, inflammatory rheumatism)
Trial locations and contacts
1 site in 1 country.
About this study
The LOARAL project concerns patients who have undergone total knee arthroplasty to treat symptomatic osteoarthritis. Patient will be divided into two groups: a control group where patients will do standard rehabilitation and an experimental group where patients will do standard rehabilitation associated with the judgement of point-light display. The aim of this study is to validate the use of point-light display for the Rehabilitation of patients with a totalarthroplasty of the knee.
- Conditions
- Knee Surgery, Rehabilitation, Point Light Display
- Being tested
- Point light display
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point light displayOther
Experimental group who will do usual rehabilitation and visualization of point-light human actions
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group who will do usual rehabilitation. |
| Experimental group | Experimental | Experimental group who will do usual rehabilitation and visualization of point-light human actions Receives: Other: Point light display |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the evaluation of the point light display relative to conventional rehabilitation
The time to realize the time up and go test will be assessed at inclusion and at the end of the program.
Measured: Rehabilitation during 3 weeks
Secondary outcomes (3)
Compare the evaluation of the point light display on functional recovery
Test score the time up and go and test score questionnary WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index, Bellamy et al., 1988).
Measured: At the end of the program (3 weeks max)
Compare the evaluation of the point light display on the detection and action recognition
Percentages of correct recognition of actions on the point light display
Measured: At the end of the program (3 weeks max)
Compare the evaluation of the point light display on the feeling of self-efficacy personal
Test score questionnary of self-efficacy personal (Dumont et al., 2000).
Measured: At the end of the program (3 weeks max)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start14 Jan 2020
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee SurgeryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856983
- Sponsor's protocol ID
- 2019-A00450-57
- Acronym
- LOARAL
- Status last verified
- Sep 2021
- First submitted
- 20 Feb 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Observing Point-light Displays in Postoperative Rehabilitation of the Total Knee Prosthesis.
- ClinicalTrials.gov ID
- NCT03856983
- Acronym / sponsor ID
- LOARAL / 2019-A00450-57
- Conditions
- Knee Surgery, Rehabilitation, Point Light Display
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 27 Feb 2019 (actual)
- 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.
The LOARAL project concerns patients who have undergone total knee arthroplasty to treat symptomatic osteoarthritis. Patient will be divided into two groups: a control group where patients will do standard rehabilitation and an experimental group where patients will do standard rehabilitation associated with the judgement of point-light display. The aim of this study is to validate the use of point-light display for the Rehabilitation of patients with a totalarthroplasty of the knee.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group who will do usual rehabilitation. |
| Experimental group | Experimental | Other: Point light displayExperimental group who will do usual rehabilitation and visualization of point-light human actions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteers over 18 years of age who have undergone knee surgery
Key exclusion criteria (3 listed)
- Any locomotor condition not due to knee surgery
- Uncorrected visual disturbances
- Comorbidity altering locomotion (history of stroke, neurological condition, inflammatory rheumatism)
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 |
|---|---|---|
| Point light displayExperimental group who will do usual rehabilitation and visualization of point-light human actions | Other | Experimental group |
Primary outcome
Compare the evaluation of the point light display relative to conventional rehabilitation
Time frame: Rehabilitation during 3 weeks
The time to realize the time up and go test will be assessed at inclusion and at the end of the program.
3 secondary outcomes
Compare the evaluation of the point light display on functional recovery
Time frame: At the end of the program (3 weeks max)
Compare the evaluation of the point light display on the detection and action recognition
Time frame: At the end of the program (3 weeks max)
Compare the evaluation of the point light display on the feeling of self-efficacy personal
Time frame: At the end of the program (3 weeks max)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
Related trials for Knee Surgery
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Active, not recruiting
ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
Revision Total Knee Arthroplasty
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point light display in people with Knee Surgery and Rehabilitation, run by Poitiers University Hospital 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 29 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the evaluation of the point light display relative to conventional rehabilitation (time frame: Rehabilitation during 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2021.