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Contralateral Strength-training After Anterior Cruciate Ligament (ACL) Reconstruction

Primary Purpose

Muscle Weakness After Anterior Cruciate Ligament Reconstruction

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
eccentric training
Sponsored by
Schulthess Klinik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscle Weakness After Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients scheduled for ACL reconstruction surgery

Exclusion Criteria:

  • Concomitant lower limb injury or disorder
  • previous lower extremity open surgery on the contralateral lower limb
  • cardiac disease
  • pregnancy

Sites / Locations

  • Neuromuscular Research Laboratory, Schulthess KlinikRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

NMES

eccentric training

sham NMES

Arm Description

neuromuscular electrical stimulation (NMES) of the quadriceps muscle with Kneehab

unilateral eccentric resistance exercises

neuromuscular electrical stimulation of the quadriceps muscle with intensity which causes no visible contraction or displacement of the leg (activation below motor threshold)

Outcomes

Primary Outcome Measures

Change in bilateral quadriceps muscle strength [Nm]
Change in quadriceps muscle activation

Secondary Outcome Measures

Change in muscle architecture
Change in self-reported questionnaire outcomes (KOOS, WOMAClk)
functional test outcomes
Assessment of present functional status by means of hop tests

Full Information

First Posted
May 29, 2013
Last Updated
April 27, 2015
Sponsor
Schulthess Klinik
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1. Study Identification

Unique Protocol Identification Number
NCT01901965
Brief Title
Contralateral Strength-training After Anterior Cruciate Ligament (ACL) Reconstruction
Official Title
Could Contralateral Quadriceps Strength Training Attenuate the Strength Loss in the ACL-operated Knee?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schulthess Klinik

4. Oversight

5. Study Description

Brief Summary
The main aims of the study are (1) to examine the impact of contralateral strength training on the quadriceps muscle function after ACL surgery and (2) to compare the magnitude of cross-education induced by NMES versus eccentric strength training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness After Anterior Cruciate Ligament Reconstruction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMES
Arm Type
Experimental
Arm Description
neuromuscular electrical stimulation (NMES) of the quadriceps muscle with Kneehab
Arm Title
eccentric training
Arm Type
Experimental
Arm Description
unilateral eccentric resistance exercises
Arm Title
sham NMES
Arm Type
Sham Comparator
Arm Description
neuromuscular electrical stimulation of the quadriceps muscle with intensity which causes no visible contraction or displacement of the leg (activation below motor threshold)
Intervention Type
Behavioral
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Type
Behavioral
Intervention Name(s)
eccentric training
Primary Outcome Measure Information:
Title
Change in bilateral quadriceps muscle strength [Nm]
Time Frame
1-2weeks preoperative/ 2weeks/ 8weeks/ 6month
Title
Change in quadriceps muscle activation
Time Frame
1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month
Secondary Outcome Measure Information:
Title
Change in muscle architecture
Time Frame
1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month
Title
Change in self-reported questionnaire outcomes (KOOS, WOMAClk)
Time Frame
1-2weeks preoperative/ 2weeks/ 8weeks/ 6 month
Title
functional test outcomes
Description
Assessment of present functional status by means of hop tests
Time Frame
6month postop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients scheduled for ACL reconstruction surgery Exclusion Criteria: Concomitant lower limb injury or disorder previous lower extremity open surgery on the contralateral lower limb cardiac disease pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa D Wellauer
Phone
+41 44 385 7984
Email
Vanessa.Wellauer@kws.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola A Maffiuletti, PhD
Organizational Affiliation
Schulthess Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuromuscular Research Laboratory, Schulthess Klinik
City
Zurich
State/Province
ZH
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa D Wellauer
Phone
+41 44 385 7984
Email
Vanessa.Wellauer@kws.ch
First Name & Middle Initial & Last Name & Degree
Vanessa D Wellauer

12. IPD Sharing Statement

Citations:
PubMed Identifier
21343386
Citation
Feil S, Newell J, Minogue C, Paessler HH. The effectiveness of supplementing a standard rehabilitation program with superimposed neuromuscular electrical stimulation after anterior cruciate ligament reconstruction: a prospective, randomized, single-blind study. Am J Sports Med. 2011 Jun;39(6):1238-47. doi: 10.1177/0363546510396180. Epub 2011 Feb 22.
Results Reference
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PubMed Identifier
10198150
Citation
Hortobagyi T, Scott K, Lambert J, Hamilton G, Tracy J. Cross-education of muscle strength is greater with stimulated than voluntary contractions. Motor Control. 1999 Apr;3(2):205-19. doi: 10.1123/mcj.3.2.205.
Results Reference
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Contralateral Strength-training After Anterior Cruciate Ligament (ACL) Reconstruction

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