Knee InjuryKINCT02065518
Electromyostimulation and Strength Walking for Knee Injuries
A study testing NMES, Strength Walking and Standard Rehabilitation Protocol in people with Knee Injury, run by University of Tennessee at 2 sites in United States.
Trial summary
The purpose of this project is to compare three treatment regimens for knee injury to the standard rehabilitation protocol: 1) NMES, 2) graduated strength walking (via a weighted vest), and 3) NMES combined with graduated strength walking. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Knee Injury
- What is being tested?
- NMES, Strength Walking and Standard Rehabilitation Protocol
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Aug 2018
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A diagnosis of knee injury (internal derangement of the knee with new effusion, including knee sprain or strains, meniscal tear, cruciate ligamentous tear, and chondral flap or injury);
- A diagnosis of knee pain that is anterior knee pain, overuse pain, patella-femoral pain, and chronic pain (less than 6 months) associated with overuse syndromes which negatively impacts performance by (a) pain in 1 or both knees on most days of the month; b) self reported difficulty performing at least one or more tasks due to pain: stair climbing, rising from a chair, walking or running a quarter mile, repetitive movements such as kneeling or squatting or stooping, pain that inhibits job performance and daily activities;
- Military service member at the time of injury (active duty military and Reserve/ National Guard in active duty status);
- Age ≥18 and ≤50 years;
- Ability to provide freely given informed consent.
Who cannot join
- Fracture or injury to external knee structures such that knee extension or flexion is impaired;
- Evidence of a fracture on radiographs or clinical evidence of unstable tendon tear/rupture;
- A significant co-morbid medical condition (such as severe hypertension or neurological disorder in which NMES strength training or unsupervised exercise is contraindicated and would pose a safety threat or impair ability to participate;
- Inability or unwillingness to participate in a walking or strengthening program;
- Inability to speak and/or read English;
- Reduced sensory perception in the lower extremities;
Show all 12Show fewer
- Inability to walk on a treadmill without an assistive device;
- Vision impairment, where participant is classified as legally blind;
- Unwillingness to accept random assignment;
- Pregnancy;
- A score of 23 or greater on the Center for Epidemiological Studies- Depression scale (CES-D);
- If the person has a demand type implanted pacemaker or defibrillator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Malcolm Grow Medical Clinics and Surgery Center
Andrews Air Force Base, Maryland, 20762
Walter Reed National Military Medical Cener
Bethesda, Maryland, 20889
About this study
The purpose of this project is to compare three treatment regimens for knee injury to the standard rehabilitation protocol: 1) NMES, 2) graduated strength walking (via a weighted vest), and 3) NMES combined with graduated strength walking. Each treatment arm will be supplemented by the standard of care and compared to a group who receive the standard rehabilitation only.
The Study will compare the effects of NMES, Strength Walking and combined NMES/ Strength Walking on strength, mobility, symptomatology, and Quality of Life (QOL) in military members with knee injury to a standard rehabilitation protocol program only. All groups will participate in standard rehabilitation protocol. The groups will be assessed over 18 weeks to compare main and interactive effects over time.
Read the detailed description
The prevalence of knee injuries has shown a striking increase of >24% over the last 5 years, affecting work performance, limiting mobility, and impacting military deployment health. This increase reflects the current high op-tempo and frequent deployments of a nation at war including activities related to military operations, physical fitness, and demanding training. We have shown that neuromuscular electrical stimulation (NMES) improves quadriceps muscle strength. We have also shown that a pedometer-based protocol improves fitness. The overall objective of this project is to compare three treatment regimens for knee injury to the standard rehabilitation protocol as potential treatments for improving strength, work efficiency, and mobility in active duty military personnel with a knee injury. Our central hypothesis is that the combination of NMES and walking while wearing a weighted vest will demonstrate greater improvements in muscle strength, work efficiency, and mobility, as compared to the usual care alone. The rationale is that NMES combined with graduated strength walking could produce marked improvements in muscle strength and thereby enhance work performance, readiness and fitness, decrease physical symptoms and faster return to duty. NMES and graduated strength walking, simulate the current uniform in the theatre of operation (body armor).The specific aims are to compare the effectiveness of three treatment regimens to the usual care in improving: (1) muscle strength, (2) work efficiency, (3) mobility, (4) symptoms/pain, and (5) quality of life. After baseline testing, we propose to randomly assign male and female subjects (n=132) ages 18 to 50 years with a knee injury to one of 4 groups: 1) NMES, 2) strength walking, 3) NMES and strength walking, or 4) usual care. All groups will receive 12-weeks of the intervention and 6-weeks of follow-up. Generalized estimating equation (GEE) methods will be used to build regression models for statistical analysis of longitudinal data. If the interventions are effective with respect to parameters of strength, mobility, work performance, and symptoms, recommendations for future treatments can be made. This is hugely important, given the rising rate of knee injuries and the possibility that provider-managed care would be critical for assisting our warriors in a rapid recovery and return to duty.
- Conditions
- Knee Injury
- Being tested
- NMES, Strength Walking, Standard Rehabilitation Protocol
- Keywords
- Muscle strength, Electrical muscle stimulation, Strength training
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESDevice
Also called EMPI 300PV neuromuscular stimulator
Participants will train at 15-20% of maximal voluntary contraction (MVC) during weeks 1-3, 21-30% of MVC during weeks 3-6 and 31-40% of MVC during weeks 6-9, 41-50% of MVC during weeks 9-12, then sustain 50% of MVC during weeks 12-18. Incremental increases will be made at the 3, 6, 9, and 12-week clinic visits.
Strength WalkingBehavioural
Strength Walking participants will maintain a daily training log. Pedometer readings will form the basis for setting activity goals. Initial step goals will be 10% above the average 3-day pedometer step count taken at baseline, with a 10% increase every other week, and then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a weighted vest to begin the strengthening component. Participants will be instructed to wear the vest during their 30-minute walk, 3 to 4 days a week. The beginning weight load for the vest will be calculated using 2% of baseline body weight and it will be increased by that same amount every week thereafter until the end of the 12 weeks.
Standard Rehabilitation ProtocolBehavioural
All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
| Study group | Role | What they receive |
|---|---|---|
| Standard Rehabilitation Protocol (SRP) | Active comparator | All participants will receive the current standard of care, the physical therapy rehabilitation protocol for knee injuries at the WRNMMC and MGMCSC sites. This program includes treatment supervised by a physical therapist at the physical therapy clinics. Receives: Behavioral: Standard Rehabilitation Protocol |
| NMES w/ SRP | Experimental | In addition to the standard rehabilitation protocol, two treatment groups will receive a portable lightweight device (300PV unit) that provides clearly defined electrical stimuli. NMES training will consist of performing four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session will entail 15 minutes/leg with 15 contractions per leg. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device (EMPI, St. Paul, MN). Receives: Device: NMES; Behavioral: Standard Rehabilitation Protocol |
| Strength Walking w/ SRP | Experimental | The Strength Walking groups will participate in a Home-Based Pedometer-Driven Walking Program. All participants in this group will be given a pedometer to monitor their daily steps and, at week 7, a weighted exercise vest to begin the strengthening component. In addition to the standard WRNMMC rehabilitation protocol, a series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool and personal fitness tracker will be incorporated into their testing sessions for the first 6 weeks. At week 7, participants will be given a weighted vest to begin the strengthening component. Receives: Behavioral: Strength Walking; Behavioral: Standard Rehabilitation Protocol |
| NMES/Strength Walking w/ SRP | Experimental | In addition to the standard rehabilitation protocol, one group will receive NMES training and will participate in a Home-Based Pedometer-Driven Walking Program. This group will follow the protocol for both the NMES training and Strength Walking. Receives: Device: NMES; Behavioral: Strength Walking; Behavioral: Standard Rehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Muscle Strength- Extension
Muscle strength was measured with a handheld dynamometer for extensor knee strength of the injured and uninjured knee.
Measured: 0, 3, 6, 9, 12, and 18 weeks
Lower Extremity Muscle Strength- Flexion
Muscle strength was measured with a handheld dynamometer for flexor knee strength of the injured and uninjured knee.
Measured: 0, 3, 6, 9, 12, and 18 weeks
Lower Extremity Mobility- 6-Minute Walk Test
Mobility was measured by the distance walked at a fast pace over 6-minutes,
Measured: 0, 6, 12, and 18 weeks
Lower Extremity Strength- Chair Test
Mobility was measured by the number of complete standing and sitting cycles in 30-seconds
Measured: 0, 6, 12, and 18 weeks
Lower Extremity Mobility and Endurance- Step Test
Mobility and endurance were measured by the number of up and down step cycles completed in 2-minutes.
Measured: 0, 6, 12, and 18 weeks
Secondary outcomes (6)
Overall Pain Severity
Pain severity was measured using item 3 from the IDKC Subjective Knee Evaluation: "If you have knee pain, how severe is it?" Participants responded using a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Measured: 0, 3, 6, 9, 12, and 18 weeks
Knee Pain Following Performance Testing- 6-Minute Walk Test
Knee pain intensity after the 6-Minute Walk Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Measured: 0, 6, 12, and 18 weeks
Knee Pain Following Performance Testing- Chair Stand Test
Knee pain intensity after the 30-Second Chair Stand Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Measured: 0, 6, 12, and 18 weeks
Knee Pain Following Performance Testing- 2-Minute Step Test
Knee pain intensity after the 2-Minute Step Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.
Measured: 0, 6, 12, and 18 weeks
Activities of Daily Living- Knee Symptoms
The Activities of Daily Living Scale was used to measure self-perceived knee symptoms while performing typical activities. The knee symptom subscale ranges from "I do not have the symptom" to "The symptom prevents me from all daily activity". Scores ranged from 0-35. Higher scores are associated with diminished symptoms. A mean score was calculated.
Measured: 0, 3, 6, 9, 12, and 18 weeks
Activities of Daily Living- Activity Limitation
The Activities of Daily Living Scale was used to measure self-perceived limitations while performing typical activities. The limitation subscale ranges from "Activity is not difficult " to "I am unable to do the activity". Scores range from 0-45. Higher scores are associated with diminished symptoms. A mean score was calculated.
Measured: 0, 3, 6, 9, 12, and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2016
- Study completionAug 2018
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee InjuryStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, Malcolm Grow Medical Clinics and Surgery Center
- Responsible party
- Sponsor
- Investigators
- Laura A Talbot, PhD, RN, Principal investigator, University of Tennessee Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065518
- Sponsor's protocol ID
- HU0001-10-1-TS04
- Other IDs
- TSNRP Grant HU0001-10-1-TS04
- Acronym
- KI
- Status last verified
- Oct 2018
- First submitted
- 12 Feb 2014
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Talbot LA. (2016). Electromyostimulation and Strength Walking for Knee Injuries: Nurse Managed Care. 19 p, NTIS Report No.: PB2017102173.
Talbot LA, Brede E, Price MN, Zuber PD, Metter EJ. Self-Managed Strength Training for Active Duty Military With a Knee Injury: A Randomized Controlled Pilot Trial. Mil Med. 2019 Jul 1;184(7-8):e174-e183. doi: 10.1093/milmed/usy347.
PubMed 30690578Talbot LA, Brede E, Price M, Metter EJ. Health-related quality of life in active duty military: A secondary data analysis of two randomized controlled trials. Nurs Outlook. 2017 Sep-Oct;65(5S):S53-S60. doi: 10.1016/j.outlook.2017.07.010. Epub 2017 Jul 25.
PubMed 28830632
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyostimulation and Strength Walking for Knee Injuries
- ClinicalTrials.gov ID
- NCT02065518
- Acronym / sponsor ID
- KI / HU0001-10-1-TS04
- Conditions
- Knee Injury
- Keywords
- Muscle strength, Electrical muscle stimulation, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, Malcolm Grow Medical Clinics and Surgery Center
- Study start
- Mar 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Posted 14 Aug 2019
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 project is to compare three treatment regimens for knee injury to the standard rehabilitation protocol: 1) NMES, 2) graduated strength walking (via a weighted vest), and 3) NMES combined with graduated strength walking. Each treatment arm will be supplemented by the standard of care and compared to a group who receive the standard rehabilitation only.
The Study will compare the effects of NMES, Strength Walking and combined NMES/ Strength Walking on strength, mobility, symptomatology, and Quality of Life (QOL) in military members with knee injury to a standard rehabilitation protocol program only. All groups will participate in standard rehabilitation protocol. The groups will be assessed over 18 weeks to compare main and interactive effects over time.
Detailed description
The prevalence of knee injuries has shown a striking increase of >24% over the last 5 years, affecting work performance, limiting mobility, and impacting military deployment health. This increase reflects the current high op-tempo and frequent deployments of a nation at war including activities related to military operations, physical fitness, and demanding training. We have shown that neuromuscular electrical stimulation (NMES) improves quadriceps muscle strength. We have also shown that a pedometer-based protocol improves fitness. The overall objective of this project is to compare three treatment regimens for knee injury to the standard rehabilitation protocol as potential treatments for improving strength, work efficiency, and mobility in active duty military personnel with a knee injury. Our central hypothesis is that the combination of NMES and walking while wearing a weighted vest will demonstrate greater improvements in muscle strength, work efficiency, and mobility, as compared to the usual care alone. The rationale is that NMES combined with graduated strength walking could produce marked improvements in muscle strength and thereby enhance work performance, readiness and fitness, decrease physical symptoms and faster return to duty. NMES and graduated strength walking, simulate the current uniform in the theatre of operation (body armor).The specific aims are to compare the effectiveness of three treatment regimens to the usual care in improving: (1) muscle strength, (2) work efficiency, (3) mobility, (4) symptoms/pain, and (5) quality of life. After baseline testing, we propose to randomly assign male and female subjects (n=132) ages 18 to 50 years with a knee injury to one of 4 groups: 1) NMES, 2) strength walking, 3) NMES and strength walking, or 4) usual care. All groups will receive 12-weeks of the intervention and 6-weeks of follow-up. Generalized estimating equation (GEE) methods will be used to build regression models for statistical analysis of longitudinal data. If the interventions are effective with respect to parameters of strength, mobility, work performance, and symptoms, recommendations for future treatments can be made. This is hugely important, given the rising rate of knee injuries and the possibility that provider-managed care would be critical for assisting our warriors in a rapid recovery and return to duty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Rehabilitation Protocol (SRP) | Active comparator | Behavioral: Standard Rehabilitation ProtocolAll participants will receive the current standard of care, the physical therapy rehabilitation protocol for knee injuries at the WRNMMC and MGMCSC sites. This program includes treatment supervised by a physical therapist at the physical therapy clinics. |
| NMES w/ SRP | Experimental | Device: NMES, Behavioral: Standard Rehabilitation ProtocolIn addition to the standard rehabilitation protocol, two treatment groups will receive a portable lightweight device (300PV unit) that provides clearly defined electrical stimuli. NMES training will consist of performing four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session will entail 15 minutes/leg with 15 contractions per leg. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device (EMPI, St. Paul, MN). |
| Strength Walking w/ SRP | Experimental | Behavioral: Strength Walking, Behavioral: Standard Rehabilitation ProtocolThe Strength Walking groups will participate in a Home-Based Pedometer-Driven Walking Program. All participants in this group will be given a pedometer to monitor their daily steps and, at week 7, a weighted exercise vest to begin the strengthening component. In addition to the standard WRNMMC rehabilitation protocol, a series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool and personal fitness tracker will be incorporated into their testing sessions for the first 6 weeks. At week 7, participants will be given a weighted vest to begin the strengthening component. |
| NMES/Strength Walking w/ SRP | Experimental | Device: NMES, Behavioral: Strength Walking, Behavioral: Standard Rehabilitation ProtocolIn addition to the standard rehabilitation protocol, one group will receive NMES training and will participate in a Home-Based Pedometer-Driven Walking Program. This group will follow the protocol for both the NMES training and Strength Walking. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A diagnosis of knee injury (internal derangement of the knee with new effusion, including knee sprain or strains, meniscal tear, cruciate ligamentous tear, and chondral flap or injury);
- A diagnosis of knee pain that is anterior knee pain, overuse pain, patella-femoral pain, and chronic pain (less than 6 months) associated with overuse syndromes which negatively impacts performance by (a) pain in 1 or both knees on most days of the month; b) self reported difficulty performing at least one or more tasks due to pain: stair climbing, rising from a chair, walking or running a quarter mile, repetitive movements such as kneeling or squatting or stooping, pain that inhibits job performance and daily activities;
- Military service member at the time of injury (active duty military and Reserve/ National Guard in active duty status);
- Age ≥18 and ≤50 years;
- Ability to provide freely given informed consent.
Key exclusion criteria (12 listed)
- Fracture or injury to external knee structures such that knee extension or flexion is impaired;
- Evidence of a fracture on radiographs or clinical evidence of unstable tendon tear/rupture;
- A significant co-morbid medical condition (such as severe hypertension or neurological disorder in which NMES strength training or unsupervised exercise is contraindicated and would pose a safety threat or impair ability to participate;
- Inability or unwillingness to participate in a walking or strengthening program;
- Inability to speak and/or read English;
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 |
|---|---|---|
| NMESAlso: EMPI 300PV neuromuscular stimulatorParticipants will train at 15-20% of maximal voluntary contraction (MVC) during weeks 1-3, 21-30% of MVC during weeks 3-6 and 31-40% of MVC during weeks 6-9, 41-50% of MVC during weeks 9-12, then sustain 50% of MVC during weeks 12-18. Incremental increases will be made at the 3, 6, 9, and 12-week clinic visits. | Device | NMES w/ SRP, NMES/Strength Walking w/ SRP |
| Strength WalkingStrength Walking participants will maintain a daily training log. Pedometer readings will form the basis for setting activity goals. Initial step goals will be 10% above the average 3-day pedometer step count taken at baseline, with a 10% increase every other week, and then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a weighted vest to begin the strengthening component. Participants will be instructed to wear the vest during their 30-minute walk, 3 to 4 days a week. The beginning weight load for the vest will be calculated using 2% of baseline body weight and it will be increased by that same amount every week thereafter until the end of the 12 weeks. | Behavioural | NMES/Strength Walking w/ SRP, Strength Walking w/ SRP |
| Standard Rehabilitation ProtocolAll participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic. | Behavioural | NMES w/ SRP, NMES/Strength Walking w/ SRP, Standard Rehabilitation Protocol (SRP), Strength Walking w/ SRP |
Primary outcome
Lower Extremity Muscle Strength- Extension
Time frame: 0, 3, 6, 9, 12, and 18 weeks
Muscle strength was measured with a handheld dynamometer for extensor knee strength of the injured and uninjured knee.
Lower Extremity Muscle Strength- Flexion
Time frame: 0, 3, 6, 9, 12, and 18 weeks
Muscle strength was measured with a handheld dynamometer for flexor knee strength of the injured and uninjured knee.
Lower Extremity Mobility- 6-Minute Walk Test
Time frame: 0, 6, 12, and 18 weeks
Mobility was measured by the distance walked at a fast pace over 6-minutes,
Lower Extremity Strength- Chair Test
Time frame: 0, 6, 12, and 18 weeks
Mobility was measured by the number of complete standing and sitting cycles in 30-seconds
Lower Extremity Mobility and Endurance- Step Test
Time frame: 0, 6, 12, and 18 weeks
Mobility and endurance were measured by the number of up and down step cycles completed in 2-minutes.
6 secondary outcomes
Overall Pain Severity
Time frame: 0, 3, 6, 9, 12, and 18 weeks
Knee Pain Following Performance Testing- 6-Minute Walk Test
Time frame: 0, 6, 12, and 18 weeks
Knee Pain Following Performance Testing- Chair Stand Test
Time frame: 0, 6, 12, and 18 weeks
Knee Pain Following Performance Testing- 2-Minute Step Test
Time frame: 0, 6, 12, and 18 weeks
Activities of Daily Living- Knee Symptoms
Time frame: 0, 3, 6, 9, 12, and 18 weeks
Activities of Daily Living- Activity Limitation
Time frame: 0, 3, 6, 9, 12, and 18 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundTalbot LA. (2016). Electromyostimulation and Strength Walking for Knee Injuries: Nurse Managed Care. 19 p, NTIS Report No.: PB2017102173.
- Results publication: PubMed 30690578Talbot LA, Brede E, Price MN, Zuber PD, Metter EJ. Self-Managed Strength Training for Active Duty Military With a Knee Injury: A Randomized Controlled Pilot Trial. Mil Med. 2019 Jul 1;184(7-8):e174-e183. doi: 10.1093/milmed/usy347.
- Derived from this study: PubMed 28830632Talbot LA, Brede E, Price M, Metter EJ. Health-related quality of life in active duty military: A secondary data analysis of two randomized controlled trials. Nurs Outlook. 2017 Sep-Oct;65(5S):S53-S60. doi: 10.1016/j.outlook.2017.07.010. Epub 2017 Jul 25.
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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.
Laura A Talbot, PhD, RN principal investigator
University of Tennessee Health Sciences Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES, Strength Walking and Standard Rehabilitation Protocol in people with Knee Injury, run by University of Tennessee at 2 sites 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 5 inclusion and 12 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 14 Aug 2019). 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?
Lower Extremity Muscle Strength- Extension (time frame: 0, 3, 6, 9, 12, and 18 weeks). The study lists 5 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 NCT02065518, which also lists 3 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 28 Aug 2019.