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

Primary Purpose

Anterior Cruciate Ligament Rupture

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motor Imagery Program
Placebo program
Sponsored by
HES-SO Valais-Wallis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring ACL plasty, anterior cruciate ligament, motor imagery, postural control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Motor Imagery Group A

    Motor Imagery Group B

    Arm Description

    This group will follow a program of motor imagery.

    This group will follow a placebo program inspired from Bodyscan

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 5, 2021
    Last Updated
    October 15, 2021
    Sponsor
    HES-SO Valais-Wallis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05081661
    Brief Title
    Effects of Corporal Visualisation Program of the Static and Dynamic Balance After an Operation of the LCA
    Official Title
    The Effects of Mental Imagery on Postural Control Following Anterior Cruciate Ligament Plasty - a Pilot Study of Feasibility
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 8, 2021 (Anticipated)
    Primary Completion Date
    September 30, 2022 (Anticipated)
    Study Completion Date
    September 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    HES-SO Valais-Wallis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Cruciate Ligament Rupture
    Keywords
    ACL plasty, anterior cruciate ligament, motor imagery, postural control

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    23 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Motor Imagery Group A
    Arm Type
    Experimental
    Arm Description
    This group will follow a program of motor imagery.
    Arm Title
    Motor Imagery Group B
    Arm Type
    Placebo Comparator
    Arm Description
    This group will follow a placebo program inspired from Bodyscan
    Intervention Type
    Other
    Intervention Name(s)
    Motor Imagery Program
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Recruitment rate
    Description
    Fulfilled if the recruitment rate is above 50% of eligible patients per month.
    Time Frame
    26 Weeks
    Title
    Enrolment rate
    Description
    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 Outcome Measure Information:
    Title
    Dynamic postural control
    Description
    Modified Star Excursion Balance Test (SEBT), average length in percent
    Time Frame
    12 Weeks
    Title
    Static postural control
    Description
    Balance Error Scoring System (BESS), scoring ranges from 0 (best) to 60 (worse
    Time Frame
    12 Weeks
    Title
    Changes in the functional capacities of the operated knee
    Description
    Lysholm Questionnaire, Score range from 0 (worse disability) to 100 (less disability)
    Time Frame
    12 Weeks
    Title
    Mental representation ability
    Description
    Kinesthetic and Visual Imagery Questionnaire (KVIQ-10), scoring ranges from 0 (worse) to 50 (best)
    Time Frame
    6 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marielle Pirlet, master
    Phone
    +41586069710
    Email
    tbperceptioncorporelle@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marielle Pirlet, master
    Organizational Affiliation
    HES-SO Valais-Wallis
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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