ACL eccentric rehabilitation trial

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201602001449365
• Date of registration: 01/02/2016
• Prospective Registration: No
• Primary sponsor: UCT
• Public title: ACL eccentric rehabilitation trial
• Scientific title: A randomised control trial of reduction in biomechanical deviations in patients post anterior cruciate ligament reconstruction: A comparison of eccentric vs. concentric cycling ergometry
• Date of first enrolment: 28/11/2014
• Target sample size: 36
• Recruitment status: Recruiting
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1449
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,simple randomisation, Block size of 12,Numbered containers
• Phase: Not Applicable

Countries of recruitment

South Africa

Contacts

• Name: Sudesh Sivarasu
• Affiliation: Senior Lecturer

• Name: Sudesh Sivarasu
• Affiliation: Senior Lecturer

Key inclusion & exclusion criteria

Inclusion criteria: Are able and to start intervention 3-4 months post ACL-R Surgery

Hamstring graft ACL-R surgery (single or double bundle)

Participant is willing to complete an 8 week training protocol.

Tegner Activity Level of 4 or above.

Phases I and II of the standard rehabilitation protocols complete

Medically fit to proceed to phase III of rehabilitation (approx. > 3 months post
surgery) by completion of a Physical Activity Readiness Questionnaire (PAR-Q).If any potential risks factors are noted, a qualified physician will assess the specific risk factor to evaluate if the patient may complete an exercise programme.

Knee range of motion should be >110 degrees of full active flexion and <10 degrees of flexion in full active extension.

BMI less than 30 kg.m^2
Exclusion criteria: A moderate or severe effusion, assessed by the clinician.

Bilateral ACL-R surgery.

A symptomatic contralateral (uninvolved) knee (or leg) that limits activities of daily living (ADL).

Moderate or Severe pain in the involved knee during ADL using the Visual Analogue Scale (VAS). Categories are as follows: VAS < 30 mm - mild pain, VAS > 70 mm - severe pain, VAS from 31 mm to 69 mm - moderate pain.

A corticosteroid injection in either knee since the ACL-R surgery.

Current (last 1 week) pain or anti-inflammatory medication usage

Any other lower limb injury condition

On the contralateral limb: Any other revious lower limb ligament reconstructive
surgery, except for partial menisectomy

On the ipsilateral limb: Any other previous lower limb ligament reconstructive surgery, except for meniscus repair , or primary ACL reconstruction surgery, i.e. ACL revision surgeries using the same surgical technique may be recruited

A current Deep Vein Thrombosis.

Rheumatoid arthritis, gout or other rheumatological pathology in either the involved or uninvolved limbs.

Age minimum: 18 Year(s)
Age maximum: 40 Year(s)
Gender: Male

Health Condition(s) or Problem(s) studied

Skin and Connective Tissue Diseases

Skin and Connective Tissue Diseases
Surgery

Surgery

Intervention(s)

Eccentric

Concentric

Primary Outcome(s)

Return-to-Sports functional tests

Isokinetic knee concentric strength

Biomechanical deviations

Isokinetic knee eccentric strength

Secondary Outcome(s)

Muscle activity patterns of Quadriceps & hamstrings

Secondary ID(s)

578/2014

Source(s) of Monetary Support

National Health Scholars Programme PhD bursary

Ethics review

Status: Approved
Approval date: 30/10/2014
Contact:

UCT Human Research Ethics Committee