Anterior Cruciate Ligament RuptureNCT05081661
Effects of Corporal Visualisation Program of the Static and Dynamic Balance After an Operation of the LCA
A study testing Motor Imagery Program in people with Anterior Cruciate Ligament Rupture, run by HES-SO Valais-Wallis at 1 site in Switzerland.
Trial summary
The aim of this pilot study is to assess the feasibility of a RCT whose topic would be the effect of a motor imagery program on the postural control in persons who have undergone ACL plasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Motor Imagery Program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Mar 2022to 30 Dec 2022
- 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
- men and women of legal age
- to be capable of discernment
- to have a telephone number or email address to communicate with the investigators, to have a device with internet access to access the mental imagery programs.
- to have had an ACL surgery performed by the Doctor Siegrist within the last three days using the Hamstrings Tendon Graft or the Kenneth Jones method.
Who cannot join
- not having a good spoken knowledge of the French language
- recurrence of ACL injury in the same knee
- meniscal sutures
- associated fractures
- pre-existing balance problems (tested at recruitment)
- pre-existing neurological problems diagnosed by a doctor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mental Imagery on Postural Control Following Anterior Cruciate Ligament Plasty - a Pilot Study of Feasibility
The aim of this pilot study is to assess the feasibility of a RCT whose topic would be the effect of a motor imagery program on the postural control in persons who have undergone ACL plasty.
Read the detailed description
Primary and secondary outcomes will be measured twice at the hospital, a first time six weeks after the beginning of the intervention and a second time eight weeks after the four weeks of the intervention.
Twelves home-based motor imagery sessions will occur in four weeks, three times a week, to activate. The training sessions will last between 15 and 20 minutes. During each training session, the participant will note on his/her own "Tracking sheet" how long they listened to the audio and their comments. The "Tracking sheet" will document whether or not the patient has participated in each of the twelve sessions.
In parallel, a control group will follow a placebo programme according to the same formalities.
Twenty-three participants (min.) will take part in this study.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Motor Imagery Program, Placebo program
- Keywords
- ACL plasty, anterior cruciate ligament, motor imagery, postural control
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imagery ProgramOther
The intervention group of the study will undergo standard postoperative physical therapy treatment at their therapist. Beginning on the third day after surgery, the participant will begin an motor imagery program to be performed three times a week for four weeks. A session lasts between fifteen and twenty minutes. It begins with a body awareness phase followed by a series of three to five one-minute exercises to be repeated three times, with a one-minute break between each exercise. The program is performed independently at home using a standardized audio tape.
Placebo programOther
The control group of the study will undergo standard postoperative physiotherapy treatment at their therapist. On the third day after surgery, the participant will begin a relaxation program inspired by the mindfulness tool called Bodyscan that acts as a placebo mental imagery program. Nevertheless, the program created for this technique does not follow the Bodyscan guidelines (Jon Kabat-Zinn, 2005), as we do not want there to be any effects in favor of improved body perception on the participants, which could bring an additional biai to the study. For the sake of understanding, we have used the term "body visualization" in the various documents distributed to the participants. The program is to be performed three times a week for four weeks. A session lasts between ten and fifteen minutes. The program is performed independently at home using a standardized audio tape.
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery Group A | Experimental | This group will follow a program of motor imagery. Receives: Other: Motor Imagery Program |
| Motor Imagery Group B | Placebo comparator | This group will follow a placebo program inspired from Bodyscan Receives: Other: Placebo program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Fulfilled if the recruitment rate is above 50% of eligible patients per month.
Measured: 26 Weeks
Enrolment rate
Fulfilled if the participation rate is > 75% (Percentage of participants who completed the study and the full programme, i.e. a minimum of eleven sessions out of twelve)
Measured: 38 Weeks
Secondary outcomes (5)
Dynamic postural control
Modified Star Excursion Balance Test (SEBT), average length in percent
Measured: 12 Weeks
Static postural control
Balance Error Scoring System (BESS), scoring ranges from 0 (best) to 60 (worse
Measured: 12 Weeks
Changes in the functional capacities of the operated knee
Lysholm Questionnaire, Score range from 0 (worse disability) to 100 (less disability)
Measured: 12 Weeks
Mental representation ability
Kinesthetic and Visual Imagery Questionnaire (KVIQ-10), scoring ranges from 0 (worse) to 50 (best)
Measured: 6 Weeks
Use of Electrotherapy
Use of Electrotherapy during the rehabilitation
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start8 Mar 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- HES-SO Valais-Wallis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle Pirlet, HES-SO Valais-Wallis
- Investigators
- Marielle Pirlet, master, Principal investigator, HES-SO Valais-Wallis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081661
- Sponsor's protocol ID
- IM - CP - LCA
- Status last verified
- Nov 2023
- First submitted
- 5 Oct 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mental Imagery on Postural Control Following Anterior Cruciate Ligament Plasty - a Pilot Study of Feasibility
- ClinicalTrials.gov ID
- NCT05081661
- Acronym / sponsor ID
- IM - CP - LCA
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- ACL plasty, anterior cruciate ligament, motor imagery, postural control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- HES-SO Valais-WallisUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 Oct 2021 (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 aim of this pilot study is to assess the feasibility of a RCT whose topic would be the effect of a motor imagery program on the postural control in persons who have undergone ACL plasty.
Detailed description
Primary and secondary outcomes will be measured twice at the hospital, a first time six weeks after the beginning of the intervention and a second time eight weeks after the four weeks of the intervention.
Twelves home-based motor imagery sessions will occur in four weeks, three times a week, to activate. The training sessions will last between 15 and 20 minutes. During each training session, the participant will note on his/her own "Tracking sheet" how long they listened to the audio and their comments. The "Tracking sheet" will document whether or not the patient has participated in each of the twelve sessions.
In parallel, a control group will follow a placebo programme according to the same formalities.
Twenty-three participants (min.) will take part in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery Group A | Experimental | Other: Motor Imagery ProgramThis group will follow a program of motor imagery. |
| Motor Imagery Group B | Placebo comparator | Other: Placebo programThis group will follow a placebo program inspired from Bodyscan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- men and women of legal age
- to be capable of discernment
- to have a telephone number or email address to communicate with the investigators, to have a device with internet access to access the mental imagery programs.
- to have had an ACL surgery performed by the Doctor Siegrist within the last three days using the Hamstrings Tendon Graft or the Kenneth Jones method.
Key exclusion criteria (6 listed)
- not having a good spoken knowledge of the French language
- recurrence of ACL injury in the same knee
- meniscal sutures
- associated fractures
- pre-existing balance problems (tested at recruitment)
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 |
|---|---|---|
| Motor Imagery ProgramThe intervention group of the study will undergo standard postoperative physical therapy treatment at their therapist. Beginning on the third day after surgery, the participant will begin an motor imagery program to be performed three times a week for four weeks. A session lasts between fifteen and twenty minutes. It begins with a body awareness phase followed by a series of three to five one-minute exercises to be repeated three times, with a one-minute break between each exercise. The program is performed independently at home using a standardized audio tape. | Other | Motor Imagery Group A |
| Placebo programThe control group of the study will undergo standard postoperative physiotherapy treatment at their therapist. On the third day after surgery, the participant will begin a relaxation program inspired by the mindfulness tool called Bodyscan that acts as a placebo mental imagery program. Nevertheless, the program created for this technique does not follow the Bodyscan guidelines (Jon Kabat-Zinn, 2005), as we do not want there to be any effects in favor of improved body perception on the participants, which could bring an additional biai to the study. For the sake of understanding, we have used the term "body visualization" in the various documents distributed to the participants. The program is to be performed three times a week for four weeks. A session lasts between ten and fifteen minutes. The program is performed independently at home using a standardized audio tape. | Other | Motor Imagery Group B |
Primary outcome
Recruitment rate
Time frame: 26 Weeks
Fulfilled if the recruitment rate is above 50% of eligible patients per month.
Enrolment rate
Time frame: 38 Weeks
Fulfilled if the participation rate is > 75% (Percentage of participants who completed the study and the full programme, i.e. a minimum of eleven sessions out of twelve)
5 secondary outcomes
Dynamic postural control
Time frame: 12 Weeks
Static postural control
Time frame: 12 Weeks
Changes in the functional capacities of the operated knee
Time frame: 12 Weeks
Mental representation ability
Time frame: 6 Weeks
Use of Electrotherapy
Time frame: 6 Weeks
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 7 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Marielle Pirlet, master principal investigator
HES-SO Valais-Wallis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery Program in people with Anterior Cruciate Ligament Rupture, run by HES-SO Valais-Wallis at 1 site in Switzerland.
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 4 inclusion and 6 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 7 Nov 2023. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Recruitment rate (time frame: 26 Weeks). The study lists 2 primary outcomes in all. 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 7 Nov 2023.