Muscle Weakness After Anterior Cruciate Ligament ReconstructionNCT01901965
Contralateral Strength-training After Anterior Cruciate Ligament (ACL) Reconstruction
A study testing Neuromuscular electrical stimulation and eccentric training in people with Muscle Weakness After Anterior Cruciate Ligament Reconstruction, run by Schulthess Klinik at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness After Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Neuromuscular electrical stimulation and eccentric training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients scheduled for ACL reconstruction surgery
Who cannot join
- Concomitant lower limb injury or disorder
- previous lower extremity open surgery on the contralateral lower limb
- cardiac disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Neuromuscular Research Laboratory, Schulthess Klinik
Zurich, Canton of Zurich, 8008
About this study
Official title: Could Contralateral Quadriceps Strength Training Attenuate the Strength Loss in the ACL-operated Knee?
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.
- Being tested
- Neuromuscular electrical stimulation, eccentric training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationBehavioural
eccentric trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| NMES | Experimental | neuromuscular electrical stimulation (NMES) of the quadriceps muscle with Kneehab Receives: Behavioral: Neuromuscular electrical stimulation |
| eccentric training | Experimental | unilateral eccentric resistance exercises Receives: 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) Receives: Behavioral: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bilateral quadriceps muscle strength [Nm]
Measured: 1-2weeks preoperative/ 2weeks/ 8weeks/ 6month
Change in quadriceps muscle activation
Measured: 1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month
Secondary outcomes (3)
Change in muscle architecture
Measured: 1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month
Change in self-reported questionnaire outcomes (KOOS, WOMAClk)
Measured: 1-2weeks preoperative/ 2weeks/ 8weeks/ 6 month
functional test outcomes
Assessment of present functional status by means of hop tests
Measured: 6month postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle Weakness After Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola A Maffiuletti, PhD, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901965
- Sponsor's protocol ID
- Contralateral_01
- Status last verified
- Dec 2023
- First submitted
- 29 May 2013
- Last updated
- 19 Dec 2023
- Results posted
- No
Publications
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.
PubMed 21343386Hortobagyi 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.
PubMed 10198150
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Contralateral Quadriceps Strength Training Attenuate the Strength Loss in the ACL-operated Knee?
- ClinicalTrials.gov ID
- NCT01901965
- Acronym / sponsor ID
- Contralateral_01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMES | Experimental | Behavioral: Neuromuscular electrical stimulationneuromuscular electrical stimulation (NMES) of the quadriceps muscle with Kneehab |
| eccentric training | Experimental | Behavioral: eccentric trainingunilateral eccentric resistance exercises |
| sham NMES | Sham comparator | Behavioral: Neuromuscular electrical stimulationneuromuscular electrical stimulation of the quadriceps muscle with intensity which causes no visible contraction or displacement of the leg (activation below motor threshold) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients scheduled for ACL reconstruction surgery
Key exclusion criteria (4 listed)
- Concomitant lower limb injury or disorder
- previous lower extremity open surgery on the contralateral lower limb
- cardiac disease
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulation | Behavioural | NMES, sham NMES |
| eccentric training | Behavioural | eccentric training |
Primary outcome
Change in bilateral quadriceps muscle strength [Nm]
Time frame: 1-2weeks preoperative/ 2weeks/ 8weeks/ 6month
Change in quadriceps muscle activation
Time frame: 1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month
3 secondary outcomes
Change in muscle architecture
Time frame: 1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month
Change in self-reported questionnaire outcomes (KOOS, WOMAClk)
Time frame: 1-2weeks preoperative/ 2weeks/ 8weeks/ 6 month
functional test outcomes
Time frame: 6month postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Background: PubMed 21343386Feil 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.
- Background: PubMed 10198150Hortobagyi 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.
Related trials for Muscle Weakness After Anterior Cruciate Ligament Reconstruction
Enrolling by invitation
Post Operative Use of Neuromuscular Electrical Stimulation (NMES) Device for ACLR Patients
ACL Reconstruction, ACL Surgery
Not yet recruiting
Effects of Early Rehabilitation Using Blood Flow Restriction and/or Surface Electromyography Biofeedback on Quadriceps Activation and Strength After Anterior Cruciate Ligament Reconstruction: A Multicenter Randomized Controlled Trial
Anterior Cruciate Ligament Injuries, Knee Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola A Maffiuletti, PhD principal investigator
Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation and eccentric training in people with Muscle Weakness After Anterior Cruciate Ligament Reconstruction, run by Schulthess Klinik at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bilateral quadriceps muscle strength [Nm] (time frame: 1-2weeks preoperative/ 2weeks/ 8weeks/ 6month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01901965, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.