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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Other: Motor Imagery Program; Other: Placebo program

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marielle Pirlet, master; Phone Number: +41586069710; Email: tbperceptioncorporelle@gmail.com

Study Locations

• Switzerland
  • Sion, Switzerland, 1950
    • Marielle.Pirlet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motor Imagery Group A; This group will follow a program of motor imagery.	Other: Motor 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.
Placebo Comparator: Motor Imagery Group B; This group will follow a placebo program inspired from Bodyscan	Other: Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Fulfilled if the recruitment rate is above 50% of eligible patients per month.	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)	38 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic postural control	Modified Star Excursion Balance Test (SEBT), average length in percent	12 Weeks
Static postural control	Balance Error Scoring System (BESS), scoring ranges from 0 (best) to 60 (worse	12 Weeks
Changes in the functional capacities of the operated knee	Lysholm Questionnaire, Score range from 0 (worse disability) to 100 (less disability)	12 Weeks
Mental representation ability	Kinesthetic and Visual Imagery Questionnaire (KVIQ-10), scoring ranges from 0 (worse) to 50 (best)	6 Weeks
Use of Electrotherapy	Use of Electrotherapy during the rehabilitation	6 Weeks

Collaborators and Investigators

• Sponsor: HES-SO Valais-Wallis
• Investigators: Principal Investigator: Marielle Pirlet, master, HES-SO Valais-Wallis

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: postural control; motor imagery; anterior cruciate ligament; ACL plasty
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: IM - CP - LCA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No