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

NCT05081661 | Completed

• 1 other identifier: IM - CP - LCA
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

ACL plasty; anterior cruciate ligament; motor imagery; postural control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Dynamic postural control

  12 Weeks

• Static postural control

  12 Weeks

• Changes in the functional capacities of the operated knee

  12 Weeks

• Mental representation ability

  6 Weeks

• Use of Electrotherapy

  6 Weeks

Study Arms (2)

Motor Imagery Group A

EXPERIMENTAL

This group will follow a program of motor imagery.

Other: Motor Imagery Program

Motor Imagery Group B

PLACEBO COMPARATOR

This group will follow a placebo program inspired from Bodyscan

Other: Placebo program

Interventions

Motor Imagery Program OTHER

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.

Motor Imagery Group A

Placebo program OTHER

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.

Motor Imagery Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HES-SO Valais-Wallis: lead

Study Sites (1)

Marielle.Pirlet

Sion, 1950, Switzerland

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Marielle Pirlet, master

  HES-SO Valais-Wallis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Physiotherapist - Senior lecturer

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 18, 2021
• Study Start: March 8, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)