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

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05081661
• Other study ID #: IM - CP - LCA
• Status: Completed
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2023
• Source: HES-SO Valais-Wallis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

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 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.

Locations

Country	Name	City	State
Switzerland	Marielle.Pirlet	Sion

Sponsors (1)

Lead Sponsor	Collaborator
HES-SO Valais-Wallis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Fulfilled if the recruitment rate is above 50% of eligible patients per month.	26 Weeks
Primary	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	Dynamic postural control	Modified Star Excursion Balance Test (SEBT), average length in percent	12 Weeks
Secondary	Static postural control	Balance Error Scoring System (BESS), scoring ranges from 0 (best) to 60 (worse	12 Weeks
Secondary	Changes in the functional capacities of the operated knee	Lysholm Questionnaire, Score range from 0 (worse disability) to 100 (less disability)	12 Weeks
Secondary	Mental representation ability	Kinesthetic and Visual Imagery Questionnaire (KVIQ-10), scoring ranges from 0 (worse) to 50 (best)	6 Weeks
Secondary	Use of Electrotherapy	Use of Electrotherapy during the rehabilitation	6 Weeks