NCT01901965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

3.4 years

First QC Date

May 29, 2013

Last Update Submit

December 18, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in bilateral quadriceps muscle strength [Nm]

    1-2weeks preoperative/ 2weeks/ 8weeks/ 6month

  • Change in quadriceps muscle activation

    1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month

Secondary Outcomes (3)

  • Change in muscle architecture

    1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month

  • Change in self-reported questionnaire outcomes (KOOS, WOMAClk)

    1-2weeks preoperative/ 2weeks/ 8weeks/ 6 month

  • functional test outcomes

    6month postop

Study Arms (3)

NMES

EXPERIMENTAL

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

Behavioral: Neuromuscular electrical stimulation

eccentric training

EXPERIMENTAL

unilateral eccentric resistance exercises

Behavioral: eccentric training

sham NMES

SHAM COMPARATOR

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

Behavioral: Neuromuscular electrical stimulation

Interventions

eccentric training

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients scheduled for ACL reconstruction surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromuscular Research Laboratory, Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 21343386BACKGROUND
  • 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.

    PMID: 10198150BACKGROUND

Study Officials

  • Nicola A Maffiuletti, PhD

    Schulthess Klinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

July 17, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations