Knee Injury Clinical Trial
— KIOfficial title:
Electromyostimulation and Strength Walking for Knee Injuries
Verified date | October 2018 |
Source | University of Tennessee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | August 2018 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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; - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Malcolm Grow Medical Clinics and Surgery Center | Andrews Air Force Base | Maryland |
United States | Walter Reed National Military Medical Cener | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Tennessee | Malcolm Grow Medical Clinics and Surgery Center, Walter Reed National Military Medical Center |
United States,
Talbot Col Usafr Ret 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. — View Citation
Talbot LA. (2016). Electromyostimulation and Strength Walking for Knee Injuries: Nurse Managed Care. 19 p, NTIS Report No.: PB2017102173.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lower Extremity Muscle Strength- Extension | Muscle strength was measured with a handheld dynamometer for extensor knee strength of the injured and uninjured knee. | 0, 3, 6, 9, 12, and 18 weeks | |
Primary | Lower Extremity Muscle Strength- Flexion | Muscle strength was measured with a handheld dynamometer for flexor knee strength of the injured and uninjured knee. | 0, 3, 6, 9, 12, and 18 weeks | |
Primary | Lower Extremity Mobility- 6-Minute Walk Test | Mobility was measured by the distance walked at a fast pace over 6-minutes, | 0, 6, 12, and 18 weeks | |
Primary | Lower Extremity Strength- Chair Test | Mobility was measured by the number of complete standing and sitting cycles in 30-seconds | 0, 6, 12, and 18 weeks | |
Primary | 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. | 0, 6, 12, and 18 weeks | |
Secondary | 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. | 0, 3, 6, 9, 12, and 18 weeks | |
Secondary | 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. | 0, 6, 12, and 18 weeks | |
Secondary | 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. | 0, 6, 12, and 18 weeks | |
Secondary | 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. | 0, 6, 12, and 18 weeks | |
Secondary | 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. | 0, 3, 6, 9, 12, and 18 weeks | |
Secondary | 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. | 0, 3, 6, 9, 12, and 18 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02649322 -
Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy
|
N/A | |
Terminated |
NCT00793104 -
Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
|
Phase 3 | |
Terminated |
NCT01382173 -
Monitoring Of Helsingborg Acute Knee Injuries (MOHAK)
|
||
Completed |
NCT00332254 -
Study to Prevent Cartilage Damage Following Acute Knee Injury.
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT00687921 -
F18-Flouride PET/CT in Acute Knee Injury
|
N/A | |
Completed |
NCT01971645 -
Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy
|
Phase 3 | |
Completed |
NCT02637505 -
Norwegian Cartilage Project - Microfracture
|
N/A | |
Completed |
NCT02148172 -
Optimizing Plyometric Training for Functional Recovery Post-ACL Reconstruction
|
N/A | |
Terminated |
NCT00984594 -
Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
|
Phase 3 | |
Suspended |
NCT00696319 -
Dynamic Stability of the Anterior Cruciate Ligament (ACL) Deficient Knee
|
N/A | |
Completed |
NCT02052856 -
Anterior Cruciate Ligament (ACL) Tunnel Widening Comparing All-inside and Interference Screw Fixation Technique
|
N/A | |
Completed |
NCT00821873 -
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.
|
Phase 3 | |
Completed |
NCT01950208 -
The Munich Knee Questionnaire - Development and Validation
|
N/A | |
Completed |
NCT00894595 -
Preventing Knee Injuries in Adolescent Female Football Players
|
N/A | |
Recruiting |
NCT02636881 -
Autologous Cartilage Implantation vs Arthroscopic Debridement
|
N/A |