Trial Outcomes & Findings for Digital Versus Conventional Physical Therapy for Chronic Shoulder Tendinopathy (NCT NCT04636528)
NCT ID: NCT04636528
Last Updated: 2025-01-29
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
8 weeks after initiation of rehabilitation program
Results posted on
2025-01-29
Participant Flow
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
44
|
|
Overall Study
COMPLETED
|
39
|
35
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Digital Versus Conventional Physical Therapy for Chronic Shoulder Tendinopathy
Baseline characteristics by cohort
| Measure |
Digital Rehabilitation
n=41 Participants
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.
|
Conventional Rehabilitation
n=41 Participants
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).
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Age, Customized
<25
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
25-40
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Customized
40-60
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Customized
>60
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Woman
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Man
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Prefer not to answer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial or biracial
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body Mass Index, Continuous
|
24.21 Kg/m2
n=5 Participants
|
25.36 Kg/m2
n=7 Participants
|
24.49 Kg/m2
n=5 Participants
|
|
Body Mass Index, Customized
Underweight (<18.5)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Mass Index, Customized
Normal (18.5-25)
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Body Mass Index, Customized
Overweight (25-30)
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Body Mass Index, Customized
Obese (30-40)
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Body Mass Index, Customized
Morbidly obese (>40)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education Level
Some high school, general educational development, or less
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education Level
Some college or college degree
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Education Level
Some graduate or graduate degree
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Employment Status
Employed (part-time or full-time)
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Employment Status
Unemployed (seeking opportunities)
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Employment Status
Not employed and not seeking work
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Employment Status
Prefer not to answer
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Weekly exercise levels
None
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Weekly exercise levels
Less than 1 hour
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Weekly exercise levels
Between 1 and 2.5 hours
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Weekly exercise levels
>2.5 hours
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Laterality of shoulder pain
Right
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Laterality of shoulder pain
Left
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Laterality of shoulder pain
Both
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Previous physical therapy
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Previous or scheduled shoulder surgery
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Smoking status
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
QuickDASH
|
25 units on a scale
n=5 Participants
|
25 units on a scale
n=7 Participants
|
25 units on a scale
n=5 Participants
|
|
Pain level - worst
|
6 units on a scale
n=5 Participants
|
5 units on a scale
n=7 Participants
|
6.00 units on a scale
n=5 Participants
|
|
Pain level - least
|
1.00 units on a scale
n=5 Participants
|
2.00 units on a scale
n=7 Participants
|
1.00 units on a scale
n=5 Participants
|
|
Pain level - average
|
4.00 units on a scale
n=5 Participants
|
5.00 units on a scale
n=7 Participants
|
4.00 units on a scale
n=5 Participants
|
|
Anxiety
|
3.00 units on a scale
n=5 Participants
|
2.00 units on a scale
n=7 Participants
|
2.00 units on a scale
n=5 Participants
|
|
Depression
|
3.00 units on a scale
n=5 Participants
|
2.00 units on a scale
n=7 Participants
|
3.00 units on a scale
n=5 Participants
|
|
Surgery Intent
|
0.00 percentage
n=5 Participants
|
1.00 percentage
n=7 Participants
|
0.00 percentage
n=5 Participants
|
|
Comorbidities - High blood pressure
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Comorbidities - High blood sugar or diabetes
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Comorbidities - Cardiac conditions
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Comorbidities - Respiratory conditions
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Comorbidities - None
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: 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.
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)
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
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.
|
Conventional Rehabilitation
n=41 Participants
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).
|
|---|---|---|
|
Change in the Shortened Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH)
|
15.5 units on a scale
Interval 7.7 to 23.2
|
13.1 units on a scale
Interval 5.8 to 20.3
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: 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.
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?".
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
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.
|
Conventional Rehabilitation
n=41 Participants
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).
|
|---|---|---|
|
Change in Shoulder Pain - Worst Pain Level
|
2.6 units on a scale
Interval 2.2 to 3.0
|
1.5 units on a scale
Interval 1.2 to 1.8
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: 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.
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.
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
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.
|
Conventional Rehabilitation
n=41 Participants
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).
|
|---|---|---|
|
Surgery Intent
|
6.3 percentage
Interval 0.0 to 23.2
|
7.2 percentage
Interval 0.0 to 25.1
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: 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.
Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety.
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
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.
|
Conventional Rehabilitation
n=41 Participants
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).
|
|---|---|---|
|
Anxiety
|
2.8 units on a scale
Interval 2.1 to 3.5
|
2.2 units on a scale
Interval 1.7 to 2.7
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: This analysis includes only participants who completed the allocated digital or conventional interventions.
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.
Outcome measures
| Measure |
Digital Rehabilitation
n=39 Participants
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.
|
Conventional Rehabilitation
n=35 Participants
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).
|
|---|---|---|
|
Patient Satisfaction With Intervention
|
8 units on a scale
Interval 5.0 to 10.0
|
10 units on a scale
Interval 9.0 to 10.0
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: 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.
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?".
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
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.
|
Conventional Rehabilitation
n=41 Participants
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).
|
|---|---|---|
|
Change in Shoulder Pain - Least Pain Level
|
0.7 units on a scale
Interval 0.6 to 0.7
|
0.7 units on a scale
Interval 0.5 to 0.7
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: 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.
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?".
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
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.
|
Conventional Rehabilitation
n=41 Participants
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).
|
|---|---|---|
|
Change in Shoulder Pain - Average Pain Level
|
2.1 units on a scale
Interval 1.9 to 2.3
|
1.5 units on a scale
Interval 1.4 to 1.7
|
SECONDARY outcome
Timeframe: 8 weeks after initiation of rehabilitation programPopulation: 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.
Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression.
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
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.
|
Conventional Rehabilitation
n=41 Participants
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).
|
|---|---|---|
|
Depression
|
2.7 units on a scale
Interval 2.0 to 3.4
|
1.6 units on a scale
Interval 1.3 to 1.9
|
SECONDARY outcome
Timeframe: Program-endRate of patients who dropout from the program
Outcome measures
| Measure |
Digital Rehabilitation
n=46 Participants
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.
|
Conventional Rehabilitation
n=44 Participants
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).
|
|---|---|---|
|
Dropout Rate
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
Number of sessions performed at program-end
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
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.
|
Conventional Rehabilitation
n=41 Participants
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).
|
|---|---|---|
|
Total Sessions
|
26.1 sessions
Standard Deviation 11.6
|
13.4 sessions
Standard Deviation 4
|
SECONDARY outcome
Timeframe: 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.
Total number of minutes spent doing exercise sessions.
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
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.
|
Conventional Rehabilitation
n=41 Participants
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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|---|---|---|
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Treatment Intensity
|
461.6 minutes
Standard Deviation 218.2
|
393.9 minutes
Standard Deviation 118.8
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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.
Number of sessions performed per week in the 8-week rehabilitation program
Outcome measures
| Measure |
Digital Rehabilitation
n=41 Participants
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.
|
Conventional Rehabilitation
n=41 Participants
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).
|
|---|---|---|
|
Frequency of Sessions Per Week
|
3.3 sessions per week
Standard Deviation 1.4
|
1.68 sessions per week
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Between baseline and 8 weeks.Number of participants that completed the 8 week program.
Outcome measures
| Measure |
Digital Rehabilitation
n=46 Participants
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.
|
Conventional Rehabilitation
n=44 Participants
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).
|
|---|---|---|
|
Retention Rate
|
39 Participants
|
35 Participants
|
Adverse Events
Digital Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place