Chronic Shoulder Pain, Musculoskeletal Pain, Shoulder Tendinopathy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDigital 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.
DEVICEConventional 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).
Sponsors
University of California, San Francisco
Sword Health, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
single-center, prospective, randomised, controlled study, with two parallel groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged between 18 and 80 years of age at enrolment 2. Reporting intermittent or persistent shoulder pain for at least 12 weeks, and/or present at least 50% of the time in the past 6 months 3. Lack of visual/audio or cognitive impairment interfering with the ability to understand or comply with the program
Exclusion criteria
1. Non-English speaking 2. Residing outside greater SF area 3. Known pregnancy 4. Submitted to spinal surgery less than 3 months ago 5. Symptoms and/or signs indicative of possible infectious disorder 6. Referred pain from spine and/or thoracic outlet syndrome 7. Active cancer diagnosis or undergoing treatment for cancer 8. Cardiac, respiratory or other known disorder incompatible with at least 20 minutes of light to moderate physical activity 9. Concomitant neurological disorder (e.g. stroke, multiple sclerosis, Parkinson's disease) 10. Dementia or psychiatric disorders precluding patient from complying with a home-based exercise program 11. Illiteracy and/or serious visual or auditory impairment interfering with communication or compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) | 8 weeks after initiation of rehabilitation program | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgery Intent | 8 weeks after initiation of rehabilitation program | 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. |
| Anxiety | 8 weeks after initiation of rehabilitation program | Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety. |
| Patient Satisfaction With Intervention | 8 weeks after initiation of rehabilitation program | 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. |
| Change in Shoulder Pain - Least Pain Level | 8 weeks after initiation of rehabilitation program | 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?. |
| Change in Shoulder Pain - Average Pain Level | 8 weeks after initiation of rehabilitation program | 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?. |
| Change in Shoulder Pain - Worst Pain Level | 8 weeks after initiation of rehabilitation program | 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?. |
| Dropout Rate | Program-end | Rate of patients who dropout from the program |
| Total Sessions | 8 weeks | Number of sessions performed at program-end |
| Treatment Intensity | Between baseline and 8 weeks. | Total number of minutes spent doing exercise sessions. |
| Frequency of Sessions Per Week | 8 weeks | Number of sessions performed per week in the 8-week rehabilitation program |
| Retention Rate | Between baseline and 8 weeks. | Number of participants that completed the 8 week program. |
| Depression | 8 weeks after initiation of rehabilitation program | Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| 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). | 41 |
| Total | 82 |
Baseline characteristics
| Characteristic | Digital Rehabilitation | Conventional Rehabilitation | Total |
|---|---|---|---|
| Age, Continuous | 49.7 years STANDARD_DEVIATION 12.6 | 50.8 years STANDARD_DEVIATION 12.9 | 50.3 years STANDARD_DEVIATION 12.7 |
| Age, Customized <25 | 1 Participants | 0 Participants | 1 Participants |
| Age, Customized 25-40 | 11 Participants | 10 Participants | 21 Participants |
| Age, Customized 40-60 | 17 Participants | 19 Participants | 36 Participants |
| Age, Customized >60 | 12 Participants | 12 Participants | 24 Participants |
| Anxiety | 3.00 units on a scale | 2.00 units on a scale | 2.00 units on a scale |
| Body Mass Index, Continuous | 24.21 Kg/m2 | 25.36 Kg/m2 | 24.49 Kg/m2 |
| Body Mass Index, Customized Morbidly obese (>40) | 1 Participants | 1 Participants | 2 Participants |
| Body Mass Index, Customized Normal (18.5-25) | 22 Participants | 20 Participants | 42 Participants |
| Body Mass Index, Customized Obese (30-40) | 5 Participants | 7 Participants | 12 Participants |
| Body Mass Index, Customized Overweight (25-30) | 12 Participants | 13 Participants | 25 Participants |
| Body Mass Index, Customized Underweight (<18.5) | 1 Participants | 0 Participants | 1 Participants |
| Comorbidities - Cardiac conditions | 1 Participants | 1 Participants | 2 Participants |
| Comorbidities - High blood pressure | 6 Participants | 4 Participants | 10 Participants |
| Comorbidities - High blood sugar or diabetes | 2 Participants | 3 Participants | 5 Participants |
| Comorbidities - None | 32 Participants | 35 Participants | 67 Participants |
| Comorbidities - Respiratory conditions | 3 Participants | 1 Participants | 4 Participants |
| Depression | 3.00 units on a scale | 2.00 units on a scale | 3.00 units on a scale |
| Education Level Some college or college degree | 23 Participants | 17 Participants | 40 Participants |
| Education Level Some graduate or graduate degree | 17 Participants | 21 Participants | 38 Participants |
| Education Level Some high school, general educational development, or less | 1 Participants | 3 Participants | 4 Participants |
| Employment Status Employed (part-time or full-time) | 28 Participants | 28 Participants | 56 Participants |
| Employment Status Not employed and not seeking work | 5 Participants | 9 Participants | 14 Participants |
| Employment Status Prefer not to answer | 2 Participants | 0 Participants | 2 Participants |
| Employment Status Unemployed (seeking opportunities) | 6 Participants | 4 Participants | 10 Participants |
| Laterality of shoulder pain Both | 2 Participants | 1 Participants | 3 Participants |
| Laterality of shoulder pain Left | 13 Participants | 16 Participants | 29 Participants |
| Laterality of shoulder pain Right | 26 Participants | 24 Participants | 50 Participants |
| Pain level - average | 4.00 units on a scale | 5.00 units on a scale | 4.00 units on a scale |
| Pain level - least | 1.00 units on a scale | 2.00 units on a scale | 1.00 units on a scale |
| Pain level - worst | 6 units on a scale | 5 units on a scale | 6.00 units on a scale |
| Previous or scheduled shoulder surgery | 4 Participants | 3 Participants | 7 Participants |
| Previous physical therapy | 18 Participants | 13 Participants | 31 Participants |
| QuickDASH | 25 units on a scale | 25 units on a scale | 25 units on a scale |
| Race/Ethnicity, Customized Asian or Pacific Islander | 14 Participants | 9 Participants | 23 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Multiracial or biracial | 5 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White or Caucasian | 17 Participants | 24 Participants | 41 Participants |
| Sex/Gender, Customized Man | 16 Participants | 22 Participants | 38 Participants |
| Sex/Gender, Customized Prefer not to answer | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Woman | 24 Participants | 19 Participants | 43 Participants |
| Smoking status | 1 Participants | 1 Participants | 2 Participants |
| Surgery Intent | 0.00 percentage | 1.00 percentage | 0.00 percentage |
| Weekly exercise levels >2.5 hours | 24 Participants | 23 Participants | 47 Participants |
| Weekly exercise levels Between 1 and 2.5 hours | 10 Participants | 14 Participants | 24 Participants |
| Weekly exercise levels Less than 1 hour | 6 Participants | 4 Participants | 10 Participants |
| Weekly exercise levels None | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 0 / 41 | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
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)
Time frame: 8 weeks after initiation of rehabilitation program
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Digital Rehabilitation | Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) | 15.5 units on a scale |
| Conventional Rehabilitation | Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH) | 13.1 units on a scale |
p-value: 0.7595% CI: [-13.5, 9.8]quantile mixed-effects model
p-value: 0.7195% CI: [0.32, 2.16]Regression, Logistic
Secondary
Anxiety
Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety.
Time frame: 8 weeks after initiation of rehabilitation program
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Digital Rehabilitation | Anxiety | 2.8 units on a scale |
| Conventional Rehabilitation | Anxiety | 2.2 units on a scale |
p-value: 0.5195% CI: [-1, 0.5]Quantile mixed-effects model
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?.
Time frame: 8 weeks after initiation of rehabilitation program
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Digital Rehabilitation | Change in Shoulder Pain - Average Pain Level | 2.1 units on a scale |
| Conventional Rehabilitation | Change in Shoulder Pain - Average Pain Level | 1.5 units on a scale |
p-value: <0.00195% CI: [-1.4, -0.5]Quantile mixed-effects model
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?.
Time frame: 8 weeks after initiation of rehabilitation program
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Digital Rehabilitation | Change in Shoulder Pain - Least Pain Level | 0.7 units on a scale |
| Conventional Rehabilitation | Change in Shoulder Pain - Least Pain Level | 0.7 units on a scale |
p-value: <0.00195% CI: [-1.5, 0.6]Quantile mixed-effects model
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?.
Time frame: 8 weeks after initiation of rehabilitation program
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Digital Rehabilitation | Change in Shoulder Pain - Worst Pain Level | 2.6 units on a scale |
| Conventional Rehabilitation | Change in Shoulder Pain - Worst Pain Level | 1.5 units on a scale |
p-value: 0.1295% CI: [-1.4, -0.2]Quantile mixed-effects model
Secondary
Depression
Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression.
Time frame: 8 weeks after initiation of rehabilitation program
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Digital Rehabilitation | Depression | 2.7 units on a scale |
| Conventional Rehabilitation | Depression | 1.6 units on a scale |
p-value: 0.2795% CI: [-1.3, 0.4]Quantile mixed-effects model
Secondary
Dropout Rate
Rate of patients who dropout from the program
Time frame: Program-end
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Digital Rehabilitation | Dropout Rate | 4 Participants |
| Conventional Rehabilitation | Dropout Rate | 9 Participants |
p-value: 0.14Chi-squared
Secondary
Frequency of Sessions Per Week
Number of sessions performed per week in the 8-week rehabilitation program
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Rehabilitation | Frequency of Sessions Per Week | 3.3 sessions per week | Standard Deviation 1.4 |
| Conventional Rehabilitation | Frequency of Sessions Per Week | 1.68 sessions per week | Standard Deviation 0.4 |
p-value: <0.001Wilcoxon (Mann-Whitney)
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.
Time frame: 8 weeks after initiation of rehabilitation program
Population: This analysis includes only participants who completed the allocated digital or conventional interventions.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Digital Rehabilitation | Patient Satisfaction With Intervention | 8 units on a scale |
| Conventional Rehabilitation | Patient Satisfaction With Intervention | 10 units on a scale |
p-value: <0.001t-test, 2 sided
Secondary
Retention Rate
Number of participants that completed the 8 week program.
Time frame: Between baseline and 8 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Digital Rehabilitation | Retention Rate | 39 Participants |
| Conventional Rehabilitation | Retention Rate | 35 Participants |
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.
Time frame: 8 weeks after initiation of rehabilitation program
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Digital Rehabilitation | Surgery Intent | 6.3 percentage |
| Conventional Rehabilitation | Surgery Intent | 7.2 percentage |
p-value: 0.8995% CI: [-34.6, 30.2]Quantile mixed-effects model
Secondary
Total Sessions
Number of sessions performed at program-end
Time frame: 8 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Rehabilitation | Total Sessions | 26.1 sessions | Standard Deviation 11.6 |
| Conventional Rehabilitation | Total Sessions | 13.4 sessions | Standard Deviation 4 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Treatment Intensity
Total number of minutes spent doing exercise sessions.
Time frame: Between baseline and 8 weeks.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Rehabilitation | Treatment Intensity | 461.6 minutes | Standard Deviation 218.2 |
| Conventional Rehabilitation | Treatment Intensity | 393.9 minutes | Standard Deviation 118.8 |
p-value: 0.36Wilcoxon (Mann-Whitney)