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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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This is a single-center, prospective, randomised, controlled study, with two parallel groups, designed to assess the clinical impact of a digital exercise program against conventional rehabilitation for shoulder tendonitis. The hypothesis is that all the clinical outcomes measured will significantly improve after the program, and patients using this novel system will attain at least the same outcomes than the ones attained by the conventional PT group.
Shoulder pain is highly prevalent, being the third main complaint in primary care settings.There is a wide range of reported incidence and prevalence rates, with a median of 24.8% of adults reporting shoulder pain every month. In developed countries, 1% of adults annually consult a primary care provider due to shoulder pain.
Around 65 to 70% of shoulder pain complaints involve problems in the rotator cuff (RTC) tendons, with incidence rising higher after the 4th decade of life.Abundant data from across the world is available on the prevalence of RTC pathologies.
RTC dysfunction represent a huge burden for healthcare systems, insurance companies and employers alike. Shoulder problems account for 2.4% of all general practitioner consultations in the UK, and 4.5 million visits to physicians annually in the USA. One study in the UK20 estimated that nearly £310 million is spent on medical appointments in the first 6 months of shoulder pain onset, and additional costs of surgical procedures are estimated at approximately £30 million/year, with up to 50% of these costs related to sick leave from paid employment. More than 300,000 surgical repairs for RTC pathologies are performed annually in the USA, and the annual financial burden of RTC management was also estimated at $3 billion.
A myriad of international clinical practice guidelines have been put forth over the years, outlining the management of pain-causing shoulder disorders. Most causes of mild-to-moderate and gradual onset shoulder pain are treated initially with conservative care. Indeed, many recent studies and systematic reviews, as well as the American Academy of Orthopaedic Surgeons guidelines, support that firstly the patient should be directed to a physical therapy (PT) program and not surgery. For some specific conditions (e.g., symptomatic small to medium full-thickness RTC tears), strong evidence further supports that both PT and operative treatment attain significant improvements in patient-reported outcomes. Of note, another systematic review on treatment options for shoulder pain suggests that passive modalities, such as manual therapy, electrotherapy and taping should be avoided as mono-therapy but that they could, in specific cases, provide additional benefit when utilized in conjunction with therapeutic exercise programs. This suggests that the exercise component of PT is fundamental in the treatment of painful shoulder disorders.
Regarding rehabilitation setting, some studies show that home-based therapy, based on exercise, could be as effective as conventional PT interventions. This is in line with the recent trends in healthcare delivery, moving away from inpatient care and towards home-based care with the intent of improving cost-effectiveness. Furthermore, the need for home-based digital solutions is now felt more acutely than ever, in the face of the current pandemic. In this context, solutions enabling home-based rehabilitation without requiring real-time human supervision can be key to improving effectiveness and lowering costs, while keeping all stakeholders safe. Indeed, there are studies demonstrating the potential and cost-effectiveness of shoulder postoperative care and rehabilitation through telehealth solutions.
However, while evidence is growing that digital therapeutics (DTx) can improve outcomes, personalize care and decrease costs, there is still much ground to be explored in the field of digital therapy following RCR. Several studies can be found on the validation/development of systems/algorithms for monitoring shoulder motion to assist clinicians on patient evaluation but these do not meet the aforementioned needs and cannot be considered digital therapeutics.
There have been some advances on new technologies for shoulder rehabilitation, namely using wearable sensors and augmented reality. Of note, some of these studies focus on systems based on inertial motion trackers that can be used by the patient at home, under remote monitoring from the physical therapist. However, these are either in very preliminary stages of development or validation, with no clinical validation studies performed, or are directed at rehabilitation after stroke.
SWORD Health has developed a novel motion tracking-based digital biofeedback system for home-based physical rehabilitation - SWORD Phoenix - which is an FDA-listed class II medical device. The company has previously conducted two pilot studies (NCT03047252; NCT03045549) comparing a digital therapy program using this device against conventional face-to-face physical therapy. These studies have proven the feasibility, safety and effectiveness of this digital therapeutic on rehabilitation after total knee and hip arthroplasty.
This is a single-center, prospective, randomised, controlled study, with two parallel groups, designed to assess the clinical impact of a digital exercise program against conventional rehabilitation for shoulder tendonitis. The hypothesis is that all the clinical outcomes measured will significantly improve after the program, and patients using this novel system will attain at least the same outcomes than the ones attained by the conventional PT group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Rehabilitation | Experimental | Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist |
|
| Conventional Rehabilitation | Active Comparator | Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital rehabilitation | Device | Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) | Shoulder physical function and symptoms will be measured using the shortened Disabilities of the Arm, Shoulder and Hand questionnaire QuickDASH, ranging from 0 (zero;non-disability) to 100 (maximum disability) | 8 weeks after initiation of rehabilitation program |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Shoulder Pain - Worst Pain Level | Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your worst pain in the last 24 hours?". | 8 weeks after initiation of rehabilitation program |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Pak, PT | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Medicine and Rehabilitation Clinic | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37490337 | Derived | Pak SS, Janela D, Freitas N, Costa F, Moulder R, Molinos M, Areias AC, Bento V, Cohen SP, Yanamadala V, Souza RB, Correia FD. Comparing Digital to Conventional Physical Therapy for Chronic Shoulder Pain: Randomized Controlled Trial. J Med Internet Res. 2023 Aug 18;25:e49236. doi: 10.2196/49236. |
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The study protocol will be made available in PDF format. Aggregate study results, with anonymised individual participant data will be made available in Excel format
Upon study publication, for at least five years.
Study protocol will be made available in clinicaltrials.gov and the excel file with the aggregate results will be made available upon study publication, for at least 5 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | Digital Rehabilitation | Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist. |
| FG001 | Conventional Rehabilitation | Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant. In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics were analyzed presented for participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from the baseline analysis. As a result, the total number of participants included in the baseline analysis differs from the overall number of participants enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Digital Rehabilitation | Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) | Shoulder physical function and symptoms will be measured using the shortened Disabilities of the Arm, Shoulder and Hand questionnaire QuickDASH, ranging from 0 (zero;non-disability) to 100 (maximum disability) | This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Median | 95% Confidence Interval | units on a scale | 8 weeks after initiation of rehabilitation program |
|
8 weeks
The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered.
Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Digital Rehabilitation | Home-based 8-week rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist Digital rehabilitation: Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist. |
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The study was conducted during the COVID-19 pandemic which may have influenced compliance with physical therapy programs. The cohort included may limit generalizability. Cognitive behavioural therapy (CBT) and educational components differed between groups despite conceptual similarity. Investigators and participants were unblinded to group allocation. Absence of follow-up restricts conclusions on long-term benefits and cost-effectiveness.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fernando Dias Correia | Sword Health Inc | +1 (646) 379-6751 | fcorreia@swordhealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 8, 2020 | Dec 9, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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single-center, prospective, randomised, controlled study, with two parallel groups
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Blinding of investigators and patients regarding allocation arm will not be possible, given the nature of the intervention. Analysis of study results will be performed by an independent statistician at UCSF.
|
| Conventional rehabilitation | Device | Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant. In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week). |
|
| Surgery Intent |
Measured through the following question: "What do you think are the chances you will get shoulder surgery in the next 12 months, in %?". Minimum and maximum values of the scale are respectively 0 and 100%, with lower values representing a lower chance. |
| 8 weeks after initiation of rehabilitation program |
| Anxiety | Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety. | 8 weeks after initiation of rehabilitation program |
| Patient Satisfaction With Intervention | Measured through the following question: "On a scale from 0 to 10, how likely would you recommend this program to a friend or colleague?". Minimum value is zero and maximum is 10. Higher scores translate higher satisfaction. | 8 weeks after initiation of rehabilitation program |
| Change in Shoulder Pain - Least Pain Level | Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your least pain in the last 24 hours?". | 8 weeks after initiation of rehabilitation program |
| Change in Shoulder Pain - Average Pain Level | Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your pain over the last 7 days?". | 8 weeks after initiation of rehabilitation program |
| Depression | Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression. | 8 weeks after initiation of rehabilitation program |
| Dropout Rate | Rate of patients who dropout from the program | Program-end |
| Total Sessions | Number of sessions performed at program-end | 8 weeks |
| Treatment Intensity | Total number of minutes spent doing exercise sessions. | Between baseline and 8 weeks. |
| Frequency of Sessions Per Week | Number of sessions performed per week in the 8-week rehabilitation program | 8 weeks |
| Retention Rate | Number of participants that completed the 8 week program. | Between baseline and 8 weeks. |
| BG001 | Conventional Rehabilitation | Outpatient clinic-based 8 week rehabilitation program with face-to-face PT sessions Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face PT sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant. In addition to the face-to-face sessions, PTs will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index, Continuous | Median | Inter-Quartile Range | Kg/m2 |
|
| Body Mass Index, Customized | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Weekly exercise levels | Count of Participants | Participants |
|
| Laterality of shoulder pain | Count of Participants | Participants |
|
| Previous physical therapy | Count of Participants | Participants |
|
| Previous or scheduled shoulder surgery | Count of Participants | Participants |
|
| Smoking status | Number of participants who reported being current smokers at baseline measured through the question "Do you smoke?". Participants were classified as smokers or non-smokers based on their responses. | Count of Participants | Participants |
|
| QuickDASH | Median | Inter-Quartile Range | units on a scale |
|
| Pain level - worst | Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your worst pain in the last 24 hours?". | Median | Inter-Quartile Range | units on a scale |
|
| Pain level - least | Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your least pain in the last 24 hours?". | Median | Inter-Quartile Range | units on a scale |
|
| Pain level - average | Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your pain over the last 7 days?". | Median | Inter-Quartile Range | units on a scale |
|
| Anxiety | Measured through the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety. | Median | Inter-Quartile Range | units on a scale |
|
| Depression | Measured through the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression. | Median | Inter-Quartile Range | units on a scale |
|
| Surgery Intent | Measured through the following question: "What do you think are the chances you will get shoulder surgery in the next 12 months, in %?". Minimum and maximum values of the scale are respectively 0 and 100%, with lower values representing a lower chance. | Median | Inter-Quartile Range | percentage |
|
| Comorbidities - High blood pressure | Count of Participants | Participants |
|
| Comorbidities - High blood sugar or diabetes | Count of Participants | Participants |
|
| Comorbidities - Cardiac conditions | Count of Participants | Participants |
|
| Comorbidities - Respiratory conditions | Count of Participants | Participants |
|
| Comorbidities - None | Count of Participants | Participants |
|
| OG001 | Conventional Rehabilitation | Outpatient clinic-based 8 week rehabilitation program with face-to-face physical therapy sessions Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant. In addition to the face-to-face sessions, physical therapists will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week). |
|
|
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| Secondary | Change in Shoulder Pain - Worst Pain Level | Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your worst pain in the last 24 hours?". | This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Median | 95% Confidence Interval | units on a scale | 8 weeks after initiation of rehabilitation program |
|
|
|
|
| Secondary | Surgery Intent | Measured through the following question: "What do you think are the chances you will get shoulder surgery in the next 12 months, in %?". Minimum and maximum values of the scale are respectively 0 and 100%, with lower values representing a lower chance. | This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Median | 95% Confidence Interval | percentage | 8 weeks after initiation of rehabilitation program |
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|
|
| Secondary | Anxiety | Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety. | This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Median | 95% Confidence Interval | units on a scale | 8 weeks after initiation of rehabilitation program |
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| Secondary | Patient Satisfaction With Intervention | Measured through the following question: "On a scale from 0 to 10, how likely would you recommend this program to a friend or colleague?". Minimum value is zero and maximum is 10. Higher scores translate higher satisfaction. | This analysis includes only participants who completed the allocated digital or conventional interventions. | Posted | Median | Inter-Quartile Range | units on a scale | 8 weeks after initiation of rehabilitation program |
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| Secondary | Change in Shoulder Pain - Least Pain Level | Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your least pain in the last 24 hours?". | This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Median | 95% Confidence Interval | units on a scale | 8 weeks after initiation of rehabilitation program |
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| Secondary | Change in Shoulder Pain - Average Pain Level | Shoulder pain level within the will be measured through the following question: "On a scale of 0 to 10, where 0 is no pain and 10 the worst pain imaginable, how would you rate your pain over the last 7 days?". | This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Median | 95% Confidence Interval | units on a scale | 8 weeks after initiation of rehabilitation program |
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| Secondary | Depression | Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression. | This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Median | 95% Confidence Interval | units on a scale | 8 weeks after initiation of rehabilitation program |
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| Secondary | Dropout Rate | Rate of patients who dropout from the program | Posted | Count of Participants | Participants | Program-end |
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| Secondary | Total Sessions | Number of sessions performed at program-end | This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Mean | Standard Deviation | sessions | 8 weeks |
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| Secondary | Treatment Intensity | Total number of minutes spent doing exercise sessions. | This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Mean | Standard Deviation | minutes | Between baseline and 8 weeks. |
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| Secondary | Frequency of Sessions Per Week | Number of sessions performed per week in the 8-week rehabilitation program | This analysis includes only participants who received the allocated digital or conventional interventions. Participants who did not receive the allocated intervention were excluded from this analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study. | Posted | Mean | Standard Deviation | sessions per week | 8 weeks |
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| Secondary | Retention Rate | Number of participants that completed the 8 week program. | Posted | Count of Participants | Participants | Between baseline and 8 weeks. |
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| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Conventional Rehabilitation | Outpatient clinic-based 8 week rehabilitation program with face-to-face PT sessions Conventional rehabilitation: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face PT sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant. In addition to the face-to-face sessions, PTs will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week). | 0 | 41 | 0 | 41 | 0 | 41 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |