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The Efficacy of Rehabilitation Exercise on the Non-operative Limb Following Anterior Cruciate Ligament Reconstruction (EFCOR)

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ClinicalTrials.gov Identifier: NCT02722876
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Brief Summary:
The purpose of this study is to evaluate the efficacy of a cross-education rehabilitation intervention following anterior cruciate ligament reconstruction on ameliorating the acute losses to function and performance. The cross-education phenomenon describes the strength gain in the opposite, untrained (surgical) limb following unilateral resistance training of the 'trained' (non-surgical) limb.

Condition or disease Intervention/treatment Phase
Musculoskeletal System Other: Contralateral Rehabilitation Other: Placebo flexibility exercise Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The EFficacy of COntralateral Muscle Rehabilitation Exercise Following Anterior Cruciate Ligament Reconstruction (EFCOR)
Actual Study Start Date : January 30, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
Experimental: Contralateral rehabilitation
8-weeks of resistance training of the non-operative limb following ACL reconstruction
Other: Contralateral Rehabilitation
Patients will undergo resistance training of the thigh musculature of the non-injured (contralateral) limb 3 times per week. The exercises will consist of unilateral: knee extensions; knee flexions and; leg-press, all performed on commercially-available resistance training machines. To optimise strength gains, patients will work to the 5 repetition-maximum rule (Kraemer et al. 2002); 3 sets of each exercise will be performed and a 2-minute rest will separate each set. Sessions will take no longer than 15-20 minutes, including rest.

Placebo Comparator: Placebo flexibility exercise
8-weeks of 'placebo' flexibility training of the upper limb
Other: Placebo flexibility exercise
Patients will perform 'placebo' flexibility training of the upper limb, which will involve a time-matched stretching programme targeting the latissimus dorsi, triceps brachii, biceps brachii, trapezius and pectoral muscles of both limbs. Each stretch will be performed twice, held for 20-30 seconds each time and will be followed by a 30-second rest (McCrary et al. 2015)




Primary Outcome Measures :
  1. Muscle Strength (peak force) [ Time Frame: 8-weeks post ACL-reconstruction ]

Secondary Outcome Measures :
  1. Muscle Strength (peak force) [ Time Frame: 6-months post ACL-reconstruction ]
  2. Functional capability [ Time Frame: 8-weeks and 6-months post ACL-reconstruction ]
    1-legged hop for distance

  3. Limb symmetry index [ Time Frame: 8-weeks and 6-months post ACL-reconstruction ]
    difference in muscle function between limbs

  4. Patient perceived knee function [ Time Frame: 8-weeks and 6-months post ACL-reconstruction ]
    IKDC questionnaire

  5. Physical activity (PA) [ Time Frame: 8-weeks and 6-months post ACL-reconstruction ]
    Objective measures of PA by accelerometry



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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Mentally mature
  • Listed for unilateral ACL reconstructive surgery following informed surgical consent
  • Autologous graft tissue; either patella tendon or semitendinosus and gracilis from the ipsilateral leg

Exclusion Criteria:

  • Patients under 16 or over 50 years of age
  • Patients with systemic pathologies (e.g. renal failure)
  • Symptomatic non-operative knee
  • Additional ligament injuries, meniscal transplant and,or, articular cartilage repair to the operative knee

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722876


Contacts
Contact: Andrea Bailey, PhD 01691404165 andrea.bailey@rjah.nhs.uk
Contact: Claire Minshull, PhD 07980000316 minshullc@hotmail.com

Locations
United Kingdom
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT Recruiting
Oswestry, Shropshire, United Kingdom, SY10 7AG
Contact: Andrea Bailey, PhD    01691 404165    Andrea.Bailey@rjah.nhs.uk   
Contact: Claire Minshull, PhD    07980000316    minshullc@hotmail.com   
Principal Investigator: Andrea Bailey, PhD         
Sub-Investigator: Claire Minshull, PhD         
Sponsors and Collaborators
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Investigators
Principal Investigator: Andrea Bailey, PhD The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Responsible Party: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
ClinicalTrials.gov Identifier: NCT02722876     History of Changes
Other Study ID Numbers: EFCOR001
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust:
Rehabilitation
Cross-education