Rupture of Anterior Cruciate LigamentNCT02817399
The Effect of Functional Electrical Stimulation
A study testing Functional electrical stimulation, Neuro-muscular electrical stimulation and Active exercises in people with Rupture of Anterior Cruciate Ligament, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial summary
The purpose of this study is to examine the short term effect of functional electrical stimulation treatment versus neuro-muscular electrical stimulation on gait quality for patient after anterior cruciate ligament reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- What is being tested?
- Functional electrical stimulation, Neuro-muscular electrical stimulation and Active exercises
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Jan 2018
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Intended patients for ACL reconstruction procedure
- Age 18-30
- Committed for three sessions per week for 4 weeks
Who cannot join
- Previous surgery at the same knee
- Chronic knee swelling
- Knee injury
- History of recurrent ankle sprains, Achilles tendinopathy, or lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Functional Electrical Stimulation on Gait Quality After Anterior Cruciate Ligament Reconstruction
The purpose of this study is to examine the short term effect of functional electrical stimulation treatment versus neuro-muscular electrical stimulation on gait quality for patient after anterior cruciate ligament reconstruction.
Read the detailed description
Background: Quadriceps weakness is common following anterior cruciate ligament (ACL) reconstruction. The inadequate quadriceps strength contributes to altered gait patterns following ACL reconstruction. Neuromuscular electrical stimulation (NMES) has been shown to reduce quadriceps atrophy post-ACL reconstruction. However, the effect of functional electrical stimulation (FES), a modulation of NMES which enables quadriceps stimulation synchronized with gait, has not been tested.
Objective: The aim of this study is to evaluate the effectiveness of FES to improve the gait pattern of patients post ACL reconstruction.
Methods: Fifty six Individuals post-ACL reconstruction will be randomly placed into FES or NMES treatment group. All patients will receive a standard exercise program three sessions weekly. In addition, each group will receive a different electrical stimulation treatment: Neuromuscular Electrical Stimulation (NMES) or Functional Electrical Stimulation (FES). Outcome measures will include spatiotemporal gait measures (e.g., gait speed, single limb support, and asymmetry index), as well as isometric quadriceps strength. Measures will be taken a week before the surgery, a week after it, and one month from the beginning of rehabilitation. Strength and gait pattern will be measured. Isometric Quadriceps strength will measured using the Biodex isokinetic system, and gait analysis will be carried out through the spatio-temporal Optogait system.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Being tested
- Functional electrical stimulation, Neuro-muscular electrical stimulation, Active exercises
- Keywords
- anterior cruciate ligament reconstruction, Functional Electrical stimulation, Gait analysis, Physical therapy
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional electrical stimulationDevice
Electrical stimulation that cause muscle contraction while walking
Neuro-muscular electrical stimulationDevice
Electrical stimulation that cause muscle contraction in a stationary position
Active exercisesProcedure or surgery
Subjects will receive training exercise according to ACL reconstruction protocol
| Study group | Role | What they receive |
|---|---|---|
| Neuro-muscular electrical stimulation | Active comparator | Active exercises \& Neuro-muscular electrical stimulation in a stationary position (lying and/or sitting). Receives: Device: Neuro-muscular electrical stimulation; Procedure: Active exercises |
| Functional electrical stimulation | Experimental | Active exercises \& Functional electrical stimulation while walking. Receives: Device: Functional electrical stimulation; Procedure: Active exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of single support at each leg
The test will perform with the Optogait system (a device for the Gait Analysis). Single support phase within the gait cycle during which the body mass is carried by a single limb. This parameter calculated by percentage of stride (normally about 40%).
Measured: One year
Secondary outcomes (4)
strength symmetry
The method of assessment for this Outcome Measure is by calculated the differences between the right Quadriceps strength and the left Quadriceps strength
Measured: One year
Gait speed
Measured by kilometer per hour
Measured: One year
Step length
Measured by length of the average step for each leg
Measured: One year
Quadriceps strength
Measured by maximal peak torque in each leg (through Biodex Isokinetic dynamometer)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJan 2016
- Primary completion1 Jan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Anterior Cruciate LigamentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Collaborators
- Ariel University
- Responsible party
- Sponsor
- Investigators
- Shmuel Springer, Ph.d, Principal investigator, Physiotherapy department, school of Health Sciences, Ariel University, ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817399
- Sponsor's protocol ID
- 16022015
- Status last verified
- Jan 2018
- First submitted
- 15 Mar 2016
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Electrical Stimulation on Gait Quality After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT02817399
- Acronym / sponsor ID
- 16022015
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- anterior cruciate ligament reconstruction, Functional Electrical stimulation, Gait analysis, Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Collaborators
- Ariel University
- Study start
- Jan 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 29 Jun 2016 (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 purpose of this study is to examine the short term effect of functional electrical stimulation treatment versus neuro-muscular electrical stimulation on gait quality for patient after anterior cruciate ligament reconstruction.
Detailed description
Background: Quadriceps weakness is common following anterior cruciate ligament (ACL) reconstruction. The inadequate quadriceps strength contributes to altered gait patterns following ACL reconstruction. Neuromuscular electrical stimulation (NMES) has been shown to reduce quadriceps atrophy post-ACL reconstruction. However, the effect of functional electrical stimulation (FES), a modulation of NMES which enables quadriceps stimulation synchronized with gait, has not been tested.
Objective: The aim of this study is to evaluate the effectiveness of FES to improve the gait pattern of patients post ACL reconstruction.
Methods: Fifty six Individuals post-ACL reconstruction will be randomly placed into FES or NMES treatment group. All patients will receive a standard exercise program three sessions weekly. In addition, each group will receive a different electrical stimulation treatment: Neuromuscular Electrical Stimulation (NMES) or Functional Electrical Stimulation (FES). Outcome measures will include spatiotemporal gait measures (e.g., gait speed, single limb support, and asymmetry index), as well as isometric quadriceps strength. Measures will be taken a week before the surgery, a week after it, and one month from the beginning of rehabilitation. Strength and gait pattern will be measured. Isometric Quadriceps strength will measured using the Biodex isokinetic system, and gait analysis will be carried out through the spatio-temporal Optogait system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuro-muscular electrical stimulation | Active comparator | Device: Neuro-muscular electrical stimulation, Procedure: Active exercisesActive exercises \& Neuro-muscular electrical stimulation in a stationary position (lying and/or sitting). |
| Functional electrical stimulation | Experimental | Device: Functional electrical stimulation, Procedure: Active exercisesActive exercises \& Functional electrical stimulation while walking. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| Functional electrical stimulationElectrical stimulation that cause muscle contraction while walking | Device | Functional electrical stimulation |
| Neuro-muscular electrical stimulationElectrical stimulation that cause muscle contraction in a stationary position | Device | Neuro-muscular electrical stimulation |
| Active exercisesSubjects will receive training exercise according to ACL reconstruction protocol | Procedure or surgery | Functional electrical stimulation, Neuro-muscular electrical stimulation |
Primary outcome
Percentages of single support at each leg
Time frame: One year
The test will perform with the Optogait system (a device for the Gait Analysis). Single support phase within the gait cycle during which the body mass is carried by a single limb. This parameter calculated by percentage of stride (normally about 40%).
4 secondary outcomes
strength symmetry
Time frame: One year
Gait speed
Time frame: One year
Step length
Time frame: One year
Quadriceps strength
Time frame: One year
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 13 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Rupture of Anterior Cruciate Ligament
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Quadriceps Strengthening ACL Reconstruction
ACL Tear
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.
Shmuel Springer, Ph.d principal investigator
Physiotherapy department, school of Health Sciences, Ariel University, ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional electrical stimulation, Neuro-muscular electrical stimulation and Active exercises in people with Rupture of Anterior Cruciate Ligament, run by Medical Corps, Israel Defense Force at 1 site in Israel.
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 3 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 13 Dec 2022. 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 Israel. 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. 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?
Percentages of single support at each leg (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2022.