Anterior Cruciate Ligament Reconstruction RehabilitationNCT06973642
Evaluation of Home-based Telerehabilitation Platform to Augment Orthopedic Rehabilitation
A study testing Software as a Medical Device (WizeCare) in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The goal of this study is to assess the feasibility of utilizing a telehealth rehabilitation platform to increase patient access for individuals who have undergone orthopedic surgery. Patient participants will be seen via telehealth until they are able to be seen by an in-person physical therapist of their choice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- Software as a Medical Device (WizeCare)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that are candidates for anterior cruciate ligament reconstruction.
Who cannot join
- Visual impairment greater than 20/200 with the use of corrective lenses
- Does not own or have consistent access to a phone with data capabilities
- Has been informed by their healthcare provider that they should not participate in physical therapy services
- Participants can be excluded from the study at any time if the physical therapist determines the patient is not an appropriate candidate for telehealth therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Mississippi Medical Center
Jackson, Mississippi, 39216
Jacob Daniels, 6018154038, jbdaniels@umc.edu
About this study
The goal of this study is to assess the feasibility of utilizing a telehealth rehabilitation platform to increase patient access for individuals who have undergone orthopedic surgery.
Patient participants will be seen via telehealth until they are able to be seen by an in-person physical therapist of their choice.
Read more
Provider participants will be the physical therapist who are providing physical therapy services through the telehealth application.
Data collection:
Patient and provider post surveys Home program and scheduled visit compliance rate Healthcare information in keeping with Stand of care physical therapy practices
Feasibility criteria will be assessed to determine whether this modality improves physical therapy access for patients living in rural areas.
- Being tested
- Software as a Medical Device (WizeCare)
- Keywords
- telerehabilitation, telehealth, physical therapy, Anterior Cruciate Ligament Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Software as a Medical Device (WizeCare)Device
Telehealth services will be provided through a telerehabilitation platform with AI capabilities and markerless motion capture.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Patient participants will receive telehealth rehabilitation services Provider participants will be providing the physical therapy services. Receives: Device: Software as a Medical Device (WizeCare) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to initial physical therapy visit
Number of days from the time the patient is enrolled in the study until the time they have their first physical therapy visit
Measured: At study completion, average 1 year
Time to first physical therapy visit scheduled
Number of days from when the patient is enrolled to when their first physical therapy visit is scheduled
Measured: At study completion, average 1 year
Number of major adverse events reported from telehealth physical therapy services
Numerical count of how many major adverse events patients or providers report
Measured: Through study completion, an average of 1 year
Number of Scheduled physical therapy visits completed by enrolled patients
Number of scheduled physical therapy sessions completed by patients compared to number of sessions scheduled
Measured: At study completion, average 1 year
Number of participants' surveys that report satisfaction with telehealth services
Participants will complete surveys after each telehealth session. Number of participants' surveys that report satisfaction compared to dissatisfaction will be measured.
Measured: At study completion, average 1 year
Number of providers' surveys that report satisfaction with telehealth application use
Providers will complete surveys after each telehealth session. Number of providers' surveys that report satisfaction compared to dissatisfaction will be measured.
Measured: At study completion, average 1 year
Secondary outcomes (2)
Lower Extremity Functional Scale
Lower Extremity Functional scale is a questionniare designed to assess functional status in patients with Lower extremity problems. The scale is 0-80 with a higher score demonstrating higher functional status
Measured: Through study completion, an average of 1 year
Operative lower extremity pain
Pain in relation to the lower extremity that has undergone ACL reconstructive surgery will be measured on a 0-10 scale with 0 being no pain and 10 being worse pain.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament Reconstruction RehabilitationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility Criteria 1. ≥80% of participants will have initial physical therapy visit scheduled within 1 week of enrollment 2. ≥80% of participants will complete their first physical therapy appointment within 1 week of surgery 3. Zero major adverse events will result from telehealth physical therapy services 4. Patient's will complete ≥70% of scheduled physical therapy visits 5. ≥70% of participants will report satisfaction with telehealth services 6. \>90% of providers will report satisfaction with use of the application to provide rehabilitation services
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob B. Daniels DPT, EdD, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973642
- Sponsor's protocol ID
- UMMC-IRB-2024-178
- Other IDs
- 6 U66RH31459-06-01
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Home-based Telerehabilitation Platform to Augment Orthopedic Rehabilitation
- ClinicalTrials.gov ID
- NCT06973642
- Acronym / sponsor ID
- UMMC-IRB-2024-178
- Keywords
- telerehabilitation, telehealth, physical therapy, Anterior Cruciate Ligament Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 May 2025 (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.
The goal of this study is to assess the feasibility of utilizing a telehealth rehabilitation platform to increase patient access for individuals who have undergone orthopedic surgery.
Patient participants will be seen via telehealth until they are able to be seen by an in-person physical therapist of their choice.
Provider participants will be the physical therapist who are providing physical therapy services through the telehealth application.
Data collection:
Patient and provider post surveys Home program and scheduled visit compliance rate Healthcare information in keeping with Stand of care physical therapy practices
Feasibility criteria will be assessed to determine whether this modality improves physical therapy access for patients living in rural areas.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility Criteria 1. ≥80% of participants will have initial physical therapy visit scheduled within 1 week of enrollment 2. ≥80% of participants will complete their first physical therapy appointment within 1 week of surgery 3. Zero major adverse events will result from telehealth physical therapy services 4. Patient's will complete ≥70% of scheduled physical therapy visits 5. ≥70% of participants will report satisfaction with telehealth services 6. >90% of providers will report satisfaction with use of the application to provide rehabilitation services
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Device: Software as a Medical Device (WizeCare)Patient participants will receive telehealth rehabilitation services Provider participants will be providing the physical therapy services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that are candidates for anterior cruciate ligament reconstruction.
Key exclusion criteria (4 listed)
- Visual impairment greater than 20/200 with the use of corrective lenses
- Does not own or have consistent access to a phone with data capabilities
- Has been informed by their healthcare provider that they should not participate in physical therapy services
- Participants can be excluded from the study at any time if the physical therapist determines the patient is not an appropriate candidate for telehealth therapy.
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 |
|---|---|---|
| Software as a Medical Device (WizeCare)Telehealth services will be provided through a telerehabilitation platform with AI capabilities and markerless motion capture. | Device | Telerehabilitation |
Primary outcome
Time to initial physical therapy visit
Time frame: At study completion, average 1 year
Number of days from the time the patient is enrolled in the study until the time they have their first physical therapy visit
Time to first physical therapy visit scheduled
Time frame: At study completion, average 1 year
Number of days from when the patient is enrolled to when their first physical therapy visit is scheduled
Number of major adverse events reported from telehealth physical therapy services
Time frame: Through study completion, an average of 1 year
Numerical count of how many major adverse events patients or providers report
Number of Scheduled physical therapy visits completed by enrolled patients
Time frame: At study completion, average 1 year
Number of scheduled physical therapy sessions completed by patients compared to number of sessions scheduled
Number of participants' surveys that report satisfaction with telehealth services
Time frame: At study completion, average 1 year
Participants will complete surveys after each telehealth session. Number of participants' surveys that report satisfaction compared to dissatisfaction will be measured.
Number of providers' surveys that report satisfaction with telehealth application use
Time frame: At study completion, average 1 year
Providers will complete surveys after each telehealth session. Number of providers' surveys that report satisfaction compared to dissatisfaction will be measured.
2 secondary outcomes
Lower Extremity Functional Scale
Time frame: Through study completion, an average of 1 year
Operative lower extremity pain
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Software as a Medical Device (WizeCare) in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by University of Mississippi Medical Center 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Daniels, DPT, EdD (6018154038, jbdaniels@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to initial physical therapy visit (time frame: At study completion, average 1 year). The study lists 6 primary outcomes in all. 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 24 Jul 2025.