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CompletedNCT05081661Updated Nov 7, 2023

Effects of Corporal Visualisation Program of the Static and Dynamic Balance After an Operation of the LCA

An interventional study of Motor Imagery Program and Placebo program in Anterior Cruciate Ligament Rupture, sponsored by HES-SO Valais-Wallis. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by HES-SO Valais-Wallis · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Anterior Cruciate Ligament Rupture

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Keywords

  • ACL plasty
  • anterior cruciate ligament
  • motor imagery
  • postural control
03

In context

Rupture

557 studies on the registry are indexed under Rupture; 97 are open to participants now.

This study's enrollment of 23 is below the median of 72 across 334 interventional studies indexed under Rupture.

Browse Rupture studies →

Lead sponsor

HES-SO Valais-Wallis is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Motor Imagery Group A

    This group will follow a program of motor imagery.

    Other: Motor Imagery Program

  • Placebo comparator
    Motor Imagery Group B

    This group will follow a placebo program inspired from Bodyscan

    Other: Placebo program

Interventions

  • OtherMotor Imagery Program

    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.

  • OtherPlacebo program

    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.

06

What researchers measure

Primary outcomes

  1. Recruitment rate

    Fulfilled if the recruitment rate is above 50% of eligible patients per month.

    Time frame: 26 Weeks

  2. 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)

    Time frame: 38 Weeks

Secondary outcomes

  1. Dynamic postural control

    Modified Star Excursion Balance Test (SEBT), average length in percent

    Time frame: 12 Weeks

  2. Static postural control

    Balance Error Scoring System (BESS), scoring ranges from 0 (best) to 60 (worse

    Time frame: 12 Weeks

  3. Changes in the functional capacities of the operated knee

    Lysholm Questionnaire, Score range from 0 (worse disability) to 100 (less disability)

    Time frame: 12 Weeks

  4. Mental representation ability

    Kinesthetic and Visual Imagery Questionnaire (KVIQ-10), scoring ranges from 0 (worse) to 50 (best)

    Time frame: 6 Weeks

  5. Use of Electrotherapy

    Use of Electrotherapy during the rehabilitation

    Time frame: 6 Weeks

07

Study locations

1 site
  • Marielle.Pirlet
    Sion, 1950, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05081661
Lead sponsor
HES-SO Valais-Wallis
Responsible party
Marielle Pirlet (MSc Physiotherapist - Senior lecturer, HES-SO Valais-Wallis) — Principal investigator
First posted
Oct 18, 2021
Start date
Mar 8, 2022
Primary completion
Dec 30, 2022
Completion
Dec 30, 2022
Last update
Nov 7, 2023

Study contacts

Marielle Pirlet, master
principal investigator · HES-SO Valais-Wallis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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