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| ID | Type | Description | Link |
|---|---|---|---|
| 19KACH004 | Other Identifier | Keller |
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| Name | Class |
|---|---|
| Uniformed Services University of the Health Sciences | FED |
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In this randomized control trial, participants with running-related knee pain will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive a telehealth gait retraining intervention, an at-home exercise program, a return to running protocol, and standard physical therapy. Participants in the control group will receive an at-home exercise program, a return to running protocol, and standard physical therapy. Data will be collected before intervention, at 10-weeks, and at 14-weeks to determine efficacy of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Participants in the experimental group will receive a telehealth gait retraining intervention in addition to standard physical therapy rehabilitation for running-related knee pain, which includes: an at-home exercise program, a return to running protocol, and standard physical therapy evaluations. |
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| Control Group | Active Comparator | Participants in the control group will receive standard physical therapy rehabilitation for running-related knee pain, which includes: an at-home exercise program, a return to running protocol, and standard physical therapy evaluations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Gait Retraining | Procedure | Telehealth gait retraining is a novel approach to train participants to adopt a non-rearfoot foot strike pattern during running via telecommunications. During telehealth gait retraining, video of a participant's running form are sent to clinicians over a mobile device app and running form feedback is given. This process is repeated once a week for four weeks and then every other week until week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Worst knee pain during running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 10-weeks |
| Worst knee pain after running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 10-weeks |
| Foot strike pattern during running measured with motion capture | Portion of the foot that makes initial contact with the ground at the start of each stance phase during running. | Change from baseline to 10-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| University of Wisconsin Running Injury and Recovery Index | A 9-item questionnaire (range 0-36, higher scores indicate more function) that measures a runners assessment of running ability after sustaining a running-related injury. | Change from baseline to 10-weeks and 14-weeks |
| Worst non-knee pain during running assessed by Visual Analogue Scale (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keller Army Community Hospital - Arvin Physical Therapy | West Point | New York | 10966 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37845752 | Derived | Crowell MS, Brindle RA, Miller EM, Reilly N, Ford KR, Goss DL. The effectiveness of telehealth gait retraining in addition to standard physical therapy treatment for overuse knee injuries in soldiers: a protocol for a randomized clinical trial. Trials. 2023 Oct 16;24(1):672. doi: 10.1186/s13063-023-07502-x. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2023 | May 30, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard Physical Therapy Treatment | Procedure | Participants receiving standard Physical Therapy will visit the Physical Therapy Clinic every 2 to 3 weeks to be treated by a Physical Therapist. |
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| Return to Running Protocol | Procedure | The Return to Running protocol is a six-phase running volume progression to re-introduce running slowly and safely after experiencing a running-related injury. |
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| At Home Exercise Program | Procedure | The At Home Exercise Program consists of 4 lower leg and foot exercises that participants can perform on their own time. |
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Worst pain intensity in a region other than the knee during running in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. |
| Change from baseline to 10-weeks and 14-weeks |
| Worst knee pain overall assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity experienced overall in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 10-weeks and 14-weeks |
| Knee function assessed with the single assessment numeric evaluation method | Participants will rate their knee function on a scale of 0 (least normal) to 100 (most normal). | Change from baseline to 10-weeks and 14-weeks |
| Knee function assessed with the anterior knee pain scale | Participants will rate their level of pain, disability, and impairment associated with their knee injury using a 13-item questionnaire (range 0-100, higher scores indicate better function). | Change from baseline to 10-weeks and 14-weeks |
| Worst knee pain during running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 14-weeks |
| Worst knee pain after running assessed by Visual Analogue Scale (VAS) | Worst knee pain intensity in the past 7 days recorded using a 0 to 10 cm visual analogue scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain. | Change from baseline to 14-weeks |
| Foot strike pattern during running measured with motion capture | Portion of the foot that makes initial contact with the ground at the start of each stance phase during running. | Change from baseline to 14-weeks |