TelemedicineNCT04269473
Video Telehealth Gait Retraining for Running-Related Knee Pain
A study testing Telehealth Gait Retraining, Standard Physical Therapy Treatment and Return to Running Protocol in people with Telemedicine and Running, run by Keller Army Community Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Telemedicine, Running, Knee
- What is being tested?
- Telehealth Gait Retraining, Standard Physical Therapy Treatment and Return to Running Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2020to 1 Dec 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active Duty Soldier or Cadet between the ages of 18 to 60 years old
- Knee pain that occurs during and/or after running that was not due to a recent acute trauma (such as an accident or a fall) and that is a pain intensity of at least a '3' and no greater than a '7' on a numeric pain rating scale with '0' meaning "no pain" and '10' meaning the "worst possible pain"
- Fluent in speaking and reading English
Who cannot join
- Currently on an Army running limiting profile for something other than knee pain
- Presence of rheumatoid or neurological diseases
- Plans to deploy or permanent change of station (PCS) within 4 months
- Current lower extremity injury other than knee pain
- History of traumatic knee injury (such as a surgery, ligament tear, or meniscal tear)
- Current pregnancy
Show all 9Show fewer
- Inability to perform 20 unassisted single leg heel raises on each leg
- A non-rearfoot strike pattern during running
- Showing signs of ligamentous instability, meniscus pathology, or knee effusion
Trial locations and contacts
1 site in 1 country.
United States1 site
Keller Army Community Hospital - Arvin Physical Therapy
West Point, New York, 10966
About this study
Official title: Evaluation of a Video Telehealth Gait Retraining Program Versus a Standard Exercise and Education Program for Patients With Running-Related Knee Pain
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.
- Conditions
- Telemedicine, Running, Knee, Pain
- Being tested
- Telehealth Gait Retraining, Standard Physical Therapy Treatment, Return to Running Protocol, At Home Exercise Program
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Gait RetrainingProcedure or surgery
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.
Standard Physical Therapy TreatmentProcedure or surgery
Participants receiving standard Physical Therapy will visit the Physical Therapy Clinic every 2 to 3 weeks to be treated by a Physical Therapist.
Return to Running ProtocolProcedure or surgery
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.
At Home Exercise ProgramProcedure or surgery
The At Home Exercise Program consists of 4 lower leg and foot exercises that participants can perform on their own time.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Telehealth Gait Retraining; Procedure: Standard Physical Therapy Treatment; Procedure: Return to Running Protocol; Procedure: At Home Exercise Program |
| 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. Receives: Procedure: Standard Physical Therapy Treatment; Procedure: Return to Running Protocol; Procedure: At Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 10-weeks
Secondary outcomes (8)
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.
Measured: Change from baseline to 10-weeks and 14-weeks
Worst non-knee pain during running assessed by Visual Analogue Scale (VAS)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 14-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start14 Aug 2020
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269473
- Sponsor's protocol ID
- RHC-A-19-035
- Other IDs
- 19KACH004
- Status last verified
- May 2025
- First submitted
- 5 Feb 2020
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37845752
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Video Telehealth Gait Retraining Program Versus a Standard Exercise and Education Program for Patients With Running-Related Knee Pain
- ClinicalTrials.gov ID
- NCT04269473
- Acronym / sponsor ID
- RHC-A-19-035
- Conditions
- Telemedicine, Running, Knee, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Feb 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Telehealth Gait Retraining, Procedure: Standard Physical Therapy Treatment, Procedure: Return to Running Protocol, Procedure: At Home Exercise ProgramParticipants 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. |
| Control Group | Active comparator | Procedure: Standard Physical Therapy Treatment, Procedure: Return to Running Protocol, Procedure: At Home Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Active Duty Soldier or Cadet between the ages of 18 to 60 years old
- Knee pain that occurs during and/or after running that was not due to a recent acute trauma (such as an accident or a fall) and that is a pain intensity of at least a '3' and no greater than a '7' on a numeric pain rating scale with '0' meaning "no pain" and '10' meaning the "worst possible pain"
- Fluent in speaking and reading English
Key exclusion criteria (9 listed)
- Currently on an Army running limiting profile for something other than knee pain
- Presence of rheumatoid or neurological diseases
- Plans to deploy or permanent change of station (PCS) within 4 months
- Current lower extremity injury other than knee pain
- History of traumatic knee injury (such as a surgery, ligament tear, or meniscal tear)
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 |
|---|---|---|
| Telehealth Gait RetrainingTelehealth 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. | Procedure or surgery | Experimental Group |
| Standard Physical Therapy TreatmentParticipants receiving standard Physical Therapy will visit the Physical Therapy Clinic every 2 to 3 weeks to be treated by a Physical Therapist. | Procedure or surgery | Control Group, Experimental Group |
| Return to Running ProtocolThe Return to Running protocol is a six-phase running volume progression to re-introduce running slowly and safely after experiencing a running-related injury. | Procedure or surgery | Control Group, Experimental Group |
| At Home Exercise ProgramThe At Home Exercise Program consists of 4 lower leg and foot exercises that participants can perform on their own time. | Procedure or surgery | Control Group, Experimental Group |
Primary outcome
Worst knee pain during running assessed by Visual Analogue Scale (VAS)
Time frame: Change from baseline to 10-weeks
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.
Worst knee pain after running assessed by Visual Analogue Scale (VAS)
Time frame: Change from baseline to 10-weeks
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.
Foot strike pattern during running measured with motion capture
Time frame: Change from baseline to 10-weeks
Portion of the foot that makes initial contact with the ground at the start of each stance phase during running.
8 secondary outcomes
University of Wisconsin Running Injury and Recovery Index
Time frame: Change from baseline to 10-weeks and 14-weeks
Worst non-knee pain during running assessed by Visual Analogue Scale (VAS)
Time frame: Change from baseline to 10-weeks and 14-weeks
Worst knee pain overall assessed by Visual Analogue Scale (VAS)
Time frame: Change from baseline to 10-weeks and 14-weeks
Knee function assessed with the single assessment numeric evaluation method
Time frame: Change from baseline to 10-weeks and 14-weeks
Knee function assessed with the anterior knee pain scale
Time frame: Change from baseline to 10-weeks and 14-weeks
Worst knee pain during running assessed by Visual Analogue Scale (VAS)
Time frame: Change from baseline to 14-weeks
Worst knee pain after running assessed by Visual Analogue Scale (VAS)
Time frame: Change from baseline to 14-weeks
Foot strike pattern during running measured with motion capture
Time frame: Change from baseline to 14-weeks
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 21 May 2025.
- Derived from this study: PubMed 37845752Crowell 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Gait Retraining, Standard Physical Therapy Treatment and Return to Running Protocol in people with Telemedicine and Running, run by Keller Army Community Hospital 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 3 inclusion and 9 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 21 May 2025. 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. 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?
Worst knee pain during running assessed by Visual Analogue Scale (VAS) (time frame: Change from baseline to 10-weeks). The study lists 3 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 NCT04269473, which also lists 1 linked publication.
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 21 May 2025.