Anterior Cruciate Ligament InjuryNCT03282565
Functional Resistance Training to Improve Knee Function After ACL Reconstruction
A study testing Functional Resistance Training with Brace and Functional Resistance Training with Elastic Band in people with Anterior Cruciate Ligament Injury, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury and reconstruction can be improved with functional resistance training. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Functional Resistance Training with Brace and Functional Resistance Training with Elastic Band
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 14-40 years
- suffered an acute, complete ACL rupture
- willingness to participate in testing and follow-up as outlined in the protocol
- English-speaking
Who cannot join
- inability to provide written informed consent
- female subjects who are pregnant or are planning to become pregnant
- previous ACL injury
- previous surgery to either knee
- bony fracture accompanying ACL injury
- patients who experienced a knee dislocation;
- patients who are contraindicated for transcranial magnetic stimulation (e.g., metal implants in head, unexplained recurrent headaches, history of seizures, epileptogenic drugs, active psychiatric illness, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Resistance Training During Gait: A Novel Intervention to Improve Knee Knee Function After ACL Reconstruction
The purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury and reconstruction can be improved with functional resistance training.
Read the detailed description
Profound quadriceps weakness is ubiquitous after anterior cruciate ligament (ACL) reconstruction, and current rehabilitation approaches are not successful in optimizing quadriceps strength and knee function even years after the surgery. We hypothesize that suboptimal strength and functional outcomes after ACL surgery are due to the lack of task-specific exercise elements during strength training. This application seeks to assess whether progressive functional resistance training during gait will significantly improve quadriceps function, neural excitability, and knee mechanics during gait. The proposed studies will not only lay the foundation for a novel training paradigm, but will also improve our understanding of the mechanisms mediating neuromuscular and biomechanical changes after functional resistance training.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Functional Resistance Training with Brace, Control, Functional Resistance Training with Elastic Band
- Keywords
- ACL, Quadriceps, Muscle, Resistance Training
- 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 Resistance Training with BraceOther
A brace will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.
ControlOther
A brace will be strapped to the leg and will not apply resistance across the knee while subjects walk on a treadmill.
Functional Resistance Training with Elastic BandOther
An elastic band will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Functional Resistance Training with a Brace | Experimental | Participants will receive functional resistance training via a knee brace while walking on a treadmill 2-3 times a week for about 8 weeks. Receives: Other: Functional Resistance Training with Brace |
| Functional Resistance Training with Elastic Band | Experimental | Participants will receive functional resistance training via an elastic band attached at the ankle while walking on a treadmill 2-3 times a week for about 8 weeks. Receives: Other: Functional Resistance Training with Elastic Band |
| Control | Sham comparator | Participants will while on a treadmill without an applied resistance 2-3 times a week for about 8 weeks. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Muscle Strength
Isometric quadriceps strength was measured with the knee at 60 degrees using an isokinetic dynamometer prior to the intervention and immediately after the intervention. Post-test minus pre-test change scores were calculated.
Measured: Pre-test measurements were taken at ~9-10 weeks after ACL reconstruction and Post-test measurements were taken at ~18-20 weeks after ACL reconstruction.
Secondary outcomes (3)
Quadriceps Voluntary Activation
Quadriceps voluntary activation was measured using the burst superimposition technique and calculated using the central activation ratio (CAR). The CAR formula is calculated using the peak torque generated immediately prior to the delivery of the stimulus (or the maximum voluntary isometric contraction, MVIC) being divided by the peak torque generated as a result of the electrical stimulus (MVIC plus superimposed burst) and then multiplied by 100. Equation is: MVIC/(MVIC + superimposed burst) × 100. A CAR of 100 represents complete volitional quadriceps activation.
Voluntary activation was quantified immediately after the intervenapproximately 9-10 weeks after the int from baseline to the end of intervention will be assessed and compared between groups.
Measured: Immediately after the intervention or approximately 18-20 weeks after ACL reconstruction
Knee Flexion Angle Symmetry
The knee flexion angle (measured in degrees) during the stance phase was gathered for both limbs using three dimension motion capture and recorded while subjects walked overground. A knee flexion angle symmetry score was computed using the following formula: ensemble average of knee flexion angle of ACL limb minus the ensemble average of knee flexion angle of the non-ACL limb. The mean difference between pre-intervention and post-intervention (post minus pre) knee flexion symmetry scores were calculated for each group. Higher values suggest greater increases in knee flexion angle symmetry from pre-intervention to post-intervention.
Measured: Pre-intervention values were recorded at ~9-10 weeks after ACL reconstruction and before the start of the intervention. Post-intervention values were recorded after the 8-week intervention (~18-20 weeks after ACL reconstruction)
Knee Moment Symmetry
The sagittal plane knee moment (units Nm) during the stance phase was gathered for both limbs using three dimensional motion capture and recorded while subjects walk overground. A symmetry score was computed using the following formula: ensemble average of the knee moment of the ACL limb (Nm) - ensemble average of the knee moment of the non-ACL limb (Nm). The mean difference between pre-intervention and post-intervention knee moment symmetry scores (post minus pre) were calculated for each group. Higher values represent the greater increases in knee moment symmetry from pre-intervention to post-intervention.
Measured: Pre-intervention scores were recorded prior to the start of the intervention and approximately 9-10 weeks after ACL reconstruction. Post-intervention scores were recorded after the 8 week intervention or approximately 18-20 weeks after ACL reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start17 Mar 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Riann Palmieri-Smith, University of Michigan
- Investigators
- Riann Palmieri-Smith, PhD, Principal investigator, University of MichiganChandramouli Krishnan, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282565
- Sponsor's protocol ID
- HUM00133860
- Other IDs
- R21HD092614
- Status last verified
- Jan 2022
- First submitted
- 12 Sep 2017
- Last updated
- 18 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Resistance Training During Gait: A Novel Intervention to Improve Knee Knee Function After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT03282565
- Acronym / sponsor ID
- HUM00133860
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- ACL, Quadriceps, Muscle, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 17 Mar 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Posted 18 Jan 2022
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 if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury and reconstruction can be improved with functional resistance training.
Detailed description
Profound quadriceps weakness is ubiquitous after anterior cruciate ligament (ACL) reconstruction, and current rehabilitation approaches are not successful in optimizing quadriceps strength and knee function even years after the surgery. We hypothesize that suboptimal strength and functional outcomes after ACL surgery are due to the lack of task-specific exercise elements during strength training. This application seeks to assess whether progressive functional resistance training during gait will significantly improve quadriceps function, neural excitability, and knee mechanics during gait. The proposed studies will not only lay the foundation for a novel training paradigm, but will also improve our understanding of the mechanisms mediating neuromuscular and biomechanical changes after functional resistance training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Functional Resistance Training with a Brace | Experimental | Other: Functional Resistance Training with BraceParticipants will receive functional resistance training via a knee brace while walking on a treadmill 2-3 times a week for about 8 weeks. |
| Functional Resistance Training with Elastic Band | Experimental | Other: Functional Resistance Training with Elastic BandParticipants will receive functional resistance training via an elastic band attached at the ankle while walking on a treadmill 2-3 times a week for about 8 weeks. |
| Control | Sham comparator | Other: ControlParticipants will while on a treadmill without an applied resistance 2-3 times a week for about 8 weeks. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- aged 14-40 years
- suffered an acute, complete ACL rupture
- willingness to participate in testing and follow-up as outlined in the protocol
- English-speaking
Key exclusion criteria (7 listed)
- inability to provide written informed consent
- female subjects who are pregnant or are planning to become pregnant
- previous ACL injury
- previous surgery to either knee
- bony fracture accompanying ACL injury
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 Resistance Training with BraceA brace will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill. | Other | Functional Resistance Training with a Brace |
| ControlA brace will be strapped to the leg and will not apply resistance across the knee while subjects walk on a treadmill. | Other | Control |
| Functional Resistance Training with Elastic BandAn elastic band will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill. | Other | Functional Resistance Training with Elastic Band |
Primary outcome
Quadriceps Muscle Strength
Time frame: Pre-test measurements were taken at ~9-10 weeks after ACL reconstruction and Post-test measurements were taken at ~18-20 weeks after ACL reconstruction.
Isometric quadriceps strength was measured with the knee at 60 degrees using an isokinetic dynamometer prior to the intervention and immediately after the intervention. Post-test minus pre-test change scores were calculated.
3 secondary outcomes
Quadriceps Voluntary Activation
Time frame: Immediately after the intervention or approximately 18-20 weeks after ACL reconstruction
Knee Flexion Angle Symmetry
Time frame: Pre-intervention values were recorded at ~9-10 weeks after ACL reconstruction and before the start of the intervention. Post-intervention values were recorded after the 8-week intervention (~18-20 weeks after ACL reconstruction)
Knee Moment Symmetry
Time frame: Pre-intervention scores were recorded prior to the start of the intervention and approximately 9-10 weeks after ACL reconstruction. Post-intervention scores were recorded after the 8 week intervention or approximately 18-20 weeks after ACL reconstruction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Riann Palmieri-Smith, PhD principal investigator
University of Michigan
Chandramouli Krishnan, PhD principal investigator
University of Michigan
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 Resistance Training with Brace and Functional Resistance Training with Elastic Band in people with Anterior Cruciate Ligament Injury, run by University of Michigan at 1 site in United States.
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 4 inclusion and 7 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 18 Jan 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quadriceps Muscle Strength (time frame: Pre-test measurements were taken at ~9-10 weeks after ACL reconstruction and Post-test measurements were taken at ~18-20 weeks after ACL reconstruction.). 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 18 Jan 2022.