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

Sponsor

HES-SO Valais-Wallis (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05081661

Collaborator

(none)

Enrollment

Arms

10.7

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Rupture	Other: Motor Imagery Program Other: Placebo program	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of Mental Imagery on Postural Control Following Anterior Cruciate Ligament Plasty - a Pilot Study of Feasibility

Anticipated Study Start Date :

Nov 8, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Recruitment rate [26 Weeks]
Fulfilled if the recruitment rate is above 50% of eligible patients per month.
Enrolment rate [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)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

HES-SO Valais-Wallis

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marielle Pirlet, Teacher Master, HES-SO Valais-Wallis

ClinicalTrials.gov Identifier:

NCT05081661

Other Study ID Numbers:

IM - CP - LCA

First Posted:

Oct 18, 2021

Last Update Posted:

Oct 18, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marielle Pirlet, Teacher Master, HES-SO Valais-Wallis

ACL plasty

anterior cruciate ligament

motor imagery

postural control

Additional relevant MeSH terms:

Rupture

Study Results

No Results Posted as of Oct 18, 2021