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
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
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
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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