Spine DegenerationNCT06407427
Evaluating the Efficacy of a Mobile Application in Postoperative Rehabilitation
A study testing App for in-bed conditioning exercises in people with Spine Degeneration and Hip Arthritis, run by Yale University at 1 site in United States.
Trial summary
This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Degeneration, Hip Arthritis, Knee Osteoarthritis
- What is being tested?
- App for in-bed conditioning exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to 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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- English reading/speaking
- Are status post low-energy hip fracture, total knee/hip arthroplasty, or single to multilevel spinal fusion without paralysis
- Must be able bodied enough to participate in a mobile app tool for physical therapy
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration]
Who cannot join
- Severe cognitive impairment: Not alert and oriented to person, place, time, and reason for being the hospital; and unable to follow 2 step commands
- Severe physical impairment:
- Neurologic paralysis
- Polytraumas with restrictions incompatible with anti-gravity exercises
- Knee immobilization, bed rest
- Unstable medical conditions:
Show all 17Show fewer
- On ventilatory support
- Utilizing high degrees of oxygen support (continuous BiPAP, high flow nasal cannula, nonrebreather mask, aerosol mask >3L/min)
- Hemodynamic instability requiring pressor medication support (can include those on pressors for elevated mean arterial pressure goals (MAPs))
- Neurologically instable with strokes, hemorrhages, increased intracranial pressures
- Open wounds or surgical incisions
- Tenuous closed wounds requiring immobilization or bending restrictions
- Open wounds that are either packed/dressed or dressed with a wound vacuum
- Surgical wounds that are draining fluid or purulence
- Vulnerable populations
- Incarcerated individuals
- Patients without access to a mobile phone with iOS capability
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
Yale New Haven Hospital Saint Raphael's Campus
New Haven, Connecticut, 06510
Rajiv S Vasudevan, M.D., 650-714-7908, Rajiv.vasudevan@yale.edu
David Gargano, PA-C, 475-414-4317, david.gargano@yale.edu
About this study
Official title: Using a Mobile Application for In-Bed Conditioning Exercises for Orthopedic Postoperative Patients
This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery.
Read the detailed description
The study aims to assess the effectiveness of a mobile app-based tool in improving conditioning, mobility, and physical therapy performance among patients recovering from orthopedic surgery, particularly hip fracture fixation, spinal fusion, and total knee/hip arthroplasty. The app sets reminders for in-bed conditioning exercises, with difficulty levels adjusted based on patient feedback. The prospective, single-arm pilot study will enroll patients over 65 years old with adequate cognitive status and a mobile phone. Patient performance on the app, satisfaction metrics, and physical therapy outcomes will be evaluated, along with feedback from physical therapists. The study is conducted through the Yale New Haven Health System, with plans to enroll 15 patients initially and subsequently expand to a randomized controlled trial with 50 participants in each arm. The goal is to improve outcomes in this population, characterized by poor mobility, morbidity, and mortality rates, by supplementing inpatient rehabilitation with targeted, app-prompted exercises.
- Conditions
- Spine Degeneration, Hip Arthritis, Knee Osteoarthritis, Hip Fractures
- Being tested
- App for in-bed conditioning exercises, Usual care
- Medical subject headings
- Osteoarthritis, Knee, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App for in-bed conditioning exercisesDevice
Participants will use an application (app) in facilitating in-bed conditioning exercises for hospitalized patients
Usual careOther
All participants will receive usual care in the post-operative setting.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Care | Experimental | Post-operative usual care where patients will receive standard care plus the use of a tool. Receives: Device: App for in-bed conditioning exercises; Other: Usual care |
| Usual Care | Active comparator | Post-operative usual care where patients will receive standard care alone. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient performance during physical therapy (PT)
Patient performance during physical therapy will be assessed using The Activity Measure for Post-Acute Care (AMPAC). The AMPAC score is a comprehensive assessment tool used to evaluate a patient's functional abilities in various domains, including mobility, daily activities, and social interaction. Total score range from 6-24 with higher scores indicating the participant is able to independently perform all activities.
Measured: Initial (postoperative day 1) and Final PT Visit (at discharge approximately day 3-5 postoperative)
Secondary outcomes (7)
Patient-reported satisfaction metrics
Patients will be surveyed at the end of their intervention using 18 Likert scale (1 to 10), with 10 questions pertaining to their patient care experience, and 8 questions pertaining to their experience using the StrongRx tool. Survey will be piloted to ensure feasibility and ease of completion. Total score range 18-180 with higher scores indicating higher satisfaction.
Measured: at postoperative day 3-5
Length of stay
Length of hospital stay serves as a secondary outcome to assess the impact of the intervention on healthcare resource utilization and patient recovery. A shorter length of stay may indicate improved outcomes and efficiency of care delivery, potentially resulting from enhanced rehabilitation efforts facilitated by the tool.
Measured: an average of 3-5 days
Postoperative VAS scores
Pain management is a critical aspect of postoperative care, and VAS scores provide a reliable measure of patients' subjective pain levels. Scores will range from 0 (No Pain) to 10 (Worse Pain Possible), with emotion icons to help patients identify which pain level most closely corresponds to their current level. Higher scores indicating more pain.
Measured: immediately postoperative and day of last admission, up to 5 days
Patient performance on the app
Evaluation of patient performance on the StrongRx app includes tracking points obtained, levels achieved, and exercise sets completed per day. Number of sets completed for each exercise will accrue 1 point for the patient. There will be 3 levels of ease that that will be user directed based on whether the patient is able to easily complete the set. For each level obtained, the points will get a multiplier (1x, 2x, 3x), which corresponds to the multiple of increased repetitions of the exercise. Higher scores indicate more exercises completed.
Measured: an average of 3-5 days
Patient compliance with prescribed exercises
Compliance with prescribed exercises serves to assess the extent to which patients adhere to the recommended rehabilitation regimen. Defined as the number of missed exercises and missed sets.
Measured: an average of 3-5 days
Physical therapist feedback on app setup assistance, patient interaction, and suggestions for improvement to assess feasibility
This data will be gathered as a survey for the physical therapists working on the orthopedics floor at our study site. The survey will include questions regarding the integration of the tool within their workflow, patient interaction, performance during their standardized therapy encounters, and overall recommendation. These will be based on Likert Scale (1 to 10). Total score range 5-50, higher scores indicate more satisfaction. There are also free text questions related to facilitators and barriers.
Measured: up to 120 days
Adverse Events
Monitoring adverse events serves as a secondary outcome to evaluate the safety profile of the intervention. Tracking minor events such as hematoma, wound dehiscence, and urinary tract infections, as well as severe events including surgical site infections and pulmonary emboli, provides comprehensive data on potential risks associated with the intervention.
Measured: Up to 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start21 Jul 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DegenerationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajiv S Vasudevan, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407427
- Sponsor's protocol ID
- 2000037597
- Status last verified
- Aug 2026
- First submitted
- 6 May 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Mobile Application for In-Bed Conditioning Exercises for Orthopedic Postoperative Patients
- ClinicalTrials.gov ID
- NCT06407427
- Acronym / sponsor ID
- 2000037597
- Conditions
- Spine Degeneration, Hip Arthritis, Knee Osteoarthritis, Hip Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 May 2024 (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.
This study aims to evaluate the effectiveness of a mobile application in improving postoperative rehabilitation outcomes among patients undergoing orthopedic surgery.
Detailed description
The study aims to assess the effectiveness of a mobile app-based tool in improving conditioning, mobility, and physical therapy performance among patients recovering from orthopedic surgery, particularly hip fracture fixation, spinal fusion, and total knee/hip arthroplasty. The app sets reminders for in-bed conditioning exercises, with difficulty levels adjusted based on patient feedback. The prospective, single-arm pilot study will enroll patients over 65 years old with adequate cognitive status and a mobile phone. Patient performance on the app, satisfaction metrics, and physical therapy outcomes will be evaluated, along with feedback from physical therapists. The study is conducted through the Yale New Haven Health System, with plans to enroll 15 patients initially and subsequently expand to a randomized controlled trial with 50 participants in each arm. The goal is to improve outcomes in this population, characterized by poor mobility, morbidity, and mortality rates, by supplementing inpatient rehabilitation with targeted, app-prompted exercises.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Care | Experimental | Device: App for in-bed conditioning exercises, Other: Usual carePost-operative usual care where patients will receive standard care plus the use of a tool. |
| Usual Care | Active comparator | Other: Usual carePost-operative usual care where patients will receive standard care alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- English reading/speaking
- Are status post low-energy hip fracture, total knee/hip arthroplasty, or single to multilevel spinal fusion without paralysis
- Must be able bodied enough to participate in a mobile app tool for physical therapy
Key exclusion criteria (17 listed)
- Severe cognitive impairment: Not alert and oriented to person, place, time, and reason for being the hospital; and unable to follow 2 step commands
- Severe physical impairment:
- Unstable medical conditions:
- Open wounds or surgical incisions
- Vulnerable populations
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 |
|---|---|---|
| App for in-bed conditioning exercisesParticipants will use an application (app) in facilitating in-bed conditioning exercises for hospitalized patients | Device | Enhanced Care |
| Usual careAll participants will receive usual care in the post-operative setting. | Other | Enhanced Care, Usual Care |
Primary outcome
Change in patient performance during physical therapy (PT)
Time frame: Initial (postoperative day 1) and Final PT Visit (at discharge approximately day 3-5 postoperative)
Patient performance during physical therapy will be assessed using The Activity Measure for Post-Acute Care (AMPAC). The AMPAC score is a comprehensive assessment tool used to evaluate a patient's functional abilities in various domains, including mobility, daily activities, and social interaction. Total score range from 6-24 with higher scores indicating the participant is able to independently perform all activities.
7 secondary outcomes
Patient-reported satisfaction metrics
Time frame: at postoperative day 3-5
Length of stay
Time frame: an average of 3-5 days
Postoperative VAS scores
Time frame: immediately postoperative and day of last admission, up to 5 days
Patient performance on the app
Time frame: an average of 3-5 days
Patient compliance with prescribed exercises
Time frame: an average of 3-5 days
Physical therapist feedback on app setup assistance, patient interaction, and suggestions for improvement to assess feasibility
Time frame: up to 120 days
Adverse Events
Time frame: Up to 90 Days
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 5 Aug 2026.
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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.
Rajiv S Vasudevan, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App for in-bed conditioning exercises in people with Spine Degeneration and Hip Arthritis, run by Yale University 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 6 inclusion and 17 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 5 Aug 2026. 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 Rajiv S Vasudevan, M.D. (650-714-7908, Rajiv.vasudevan@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient performance during physical therapy (PT) (time frame: Initial (postoperative day 1) and Final PT Visit (at discharge approximately day 3-5 postoperative)). 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 5 Aug 2026.