Condition category
Musculoskeletal Diseases
Date applied
25/08/2015
Date assigned
13/09/2015
Last edited
14/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
One of the most common types of knee injury is an anterior cruciate ligament (ACL) sprain or tear. The ACL is one of the four main ligaments within the knee which connects the thigh bone (femur) to the shin bone (tibia). These injuries often result in loss of size and weakness in the quadriceps muscles (a group of four muscles in the thigh). This problem is not often addressed in current rehabilitation therapy and can put strain on other muscles, which can increase the risk of future injury. Studies have shown that full squats are far better for strengthening the quadriceps than partial squats, which are what is generally used in typical rehabilitation, as the body moves closer to the floor. Additionally, a modified squat in which the un-injured foot is raised may also be beneficial, as it focuses on restoring strength in the injured leg. The aim of this study is to investigate the benefits of full squat exercise in ACL injured people, and to find out if single-foot elevated squat exercises are better than normal squat exercises for their recovery.

Who can participate?
Adults with a one sided non-contact ACL injury that are able to participate in weight-bearing exercise.

What does the study involve?
Participants are randomly allocated into one of two exercise programs. Those in group 1 perform normal squat exercises for 10 weeks. Those in group 2 perform single-foot elevated squat exercises, where the un-injured leg is placed on a raised (elevated) surface. Single-foot elevated squats are a type of squat which focuses on building strength and improving the range of movement in one leg (in this case, the injured leg). The strength of knee extension, as well as the movements of the hip, knee and ankle are measured during sit-to-stand and vertical jump before and after the study.

What are the possible benefits and risks of participating?
Participants will benefit from restored muscle strength from the therapy, which is important for return to activity following an ACL injury. There are no anticipated risks of participating in the study.

Where is the study run from?
University of Alberta (Canada)

When is the study starting and how long is it expected to run for?
September 2015 to August 2016

Who is funding the study?
National Strength and Conditioning Association (Canada)

Who is the main contact?
1. Miss Liane Jean (Scientific)
2. Dr Loren Chiu (Public)

Trial website

Contact information

Type

Scientific

Primary contact

Miss Liane Jean

ORCID ID

Contact details

3-413 Van Vliet Complex
University of Alberta
Edmonton
T6G 2H9
Canada

Type

Public

Additional contact

Dr Loren Chiu

ORCID ID

Contact details

3-413 Van Vliet Complex
Edmonton
T6G 2H9
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of Normal and Single-Foot Elevated Full Squats in ACL Injured Persons

Acronym

Study hypothesis

This research will compare the effectiveness of normal and single-foot elevated squat exercise to restore quadriceps strength and function in the involved limb of anterior cruciate ligament (ACL) injured persons prior to surgery. It is hypothesized that single-foot elevated squats will be more effective for restoring quadriceps strength and function versus normal squats.

Ethics approval

University of Alberta Research Ethics Board 2, 11/09/2015, ref: Pro00058914

Study design

Single-centre rnadomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Non-contact anterior cruciate ligament rupture

Intervention

This trial will recruit up to 40 individuals with non-contact ACL injury. Participants will be randomly assigned to one of two exercise groups. Both groups will perform identical 10 week exercise programs, with the exception of type of squat exercise. One group will perform normal squat exercise while the second group will perform single-foot elevated squats.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Isometric knee extension strength will be measured using an isometric strength testing dynamometer before and after 10 week exercise program
2. Hip, knee and ankle net joint moments during sit-to-stand. Sit-to-Stand biomechanics will be measured using 3D motion analysis and force platforms, before and after 10 week exercise program

Secondary outcome measures

Hip, knee and ankle net joint moments during vertical jump and land. Vertical jumping and landing biomechanics will be measured using 3D motion analysis and force platforms, after 10 week exercise program.

Overall trial start date

01/09/2015

Overall trial end date

31/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 16 and 40 years
2. Unilateral, non-contact ACL injury
3. Clearance from surgeon and/or physiotherapist to participate in weight-bearing exercise

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Have had ACL reconstruction
2. Bilateral ACL injury
3. Symptomatic meniscal injury that prevents full knee flexion/extension range of motion

Recruitment start date

07/09/2015

Recruitment end date

31/05/2016

Locations

Countries of recruitment

Canada

Trial participating centre

University of Alberta
75 Van Vilet Centre
Edmonton
T6G 2H9
Canada

Sponsor information

Organisation

University of Alberta - Faculty of Physical Education and Recreation

Sponsor details

3-100 University Hall
Van Vliet Complex
Edmonton
T6G 2H9
Canada

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

National Strength and Conditioning Association

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Data from the results will be submitted as abstracts to present at conferences. A manuscript including the primary and secondary outcomes will be submitted for publication.

Intention to publish date

31/10/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes