An interventional study of Smartpatch Peripheral Nerve Stimulation (PNS) System in Post-stroke Shoulder Pain and Hemiplegic Shoulder Pain, sponsored by SPR Therapeutics, Inc.. Completed at 5 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-10-16.
Sponsored by SPR Therapeutics, Inc. (part of Medtronic) · Not applicable, Interventional, and Treatment
The purpose of this study is to determine if electrical stimulation (small levels of electricity) reduces post-stroke shoulder pain. This study involves a device called the Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).
SPR Therapeutics, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
First submitted before SPR Therapeutics, Inc. became part of Medtronic.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Subjects in the Treatment Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.
Device: Smartpatch Peripheral Nerve Stimulation (PNS) System
Subjects in the Control Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, but will not receive any electrical stimulation.
Device: Smartpatch Peripheral Nerve Stimulation (PNS) System
The Smartpatch System is an Investigation Device which delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).
Also known as: Smartpatch System, Smartpatch
Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)
A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as "please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours". BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at End of Treatment (EOT) was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for treatment was compared to the group mean of the medians scores for the control group at baseline and at EOT.
Time frame: Baseline, End of Treatment (4-weeks of Treatment/Control)
Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
Time frame: 16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment
Change From Baseline Shoulder Pain Interference at End of Treatment
The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes" within the last week. The mean of these seven scores will be calculated to obtain the pain interference score.
Time frame: Baseline, End of Treatment (4-weeks of Treatment/Control)
Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment
A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as "please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours". BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at 12 weeks post-treatment was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for 12 weeks post-treatment was compared to the group mean of the median scores for the control group at baseline.
Time frame: Baseline, 12-wks post-treatment
Change From Baseline Quality of Life at End of Treatment
The Medical Outcomes Study Short Form (SF-36v2) was administered at clinic visits to assess the impact of peripheral nerve stimulation on the subject's health-related quality of life. The SF-36v2 is a generic health survey designed to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The 36 questions were grouped into two components: physical and mental. The survey was scored using norm-based scoring algorithm where a score of 0 indicates maximum disability and a score of 100 indicates no disability. Change in each component score was derived from End of Treatment score minus baseline score.
Time frame: Baseline, End of Treatment (4-weeks of Treatment/Control)
Change From Baseline Average Pain Intensity at End of Treatment
A diary was used in the study to capture daily average shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 5 (BPI-5) and is stated as "please rate your pain by circling the one number that best describes your pain on the average". BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The mean scores were calculated for each diary period. The mean diary score at End of Treatment (EOT) was compared to the mean baseline diary score to calculate the change in pain intensity.
Time frame: Baseline, End of Treatment (4-weeks of Treatment/Control)
Patient Global Impression of Change at End of Treatment
The Patient Global Impression of Change (PGIC) scale was administered at EOT to assess subject perception of overall improvement and patient preferences. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved" relative to baseline.
Time frame: End of Treatment (4-weeks of Treatment/Control)
Change in Pain Medication Usage at End of Treatment
Subjects completed 7-day diaries, in which they listed all pain medications they took during the 7 days. A blinded third party medication committee reviewed medications collected for each 7-day diary period and scored medication changes, in comparison to the baseline diary medications as "no change" (no change in dosage or change is not clinically meaningful to impact pain outcomes), "increase" (clinically meaningful increase in medication that would impact pain outcomes), or "decrease" (clinically meaningful decrease in medication that would impact pain outcomes).
Time frame: End of Treatment (4-weeks of Treatment/Control)
Clinical Global Impression of Improvement at End of Treatment
The Blinded Evaluator rated each subject enrolled at their site using a question adapted from the Clinical Global Impression (CGI) scale, known as the Clinical Global Impression-Improvement scale (CGI-I). For the CGI-I, a Blinded Evaluator was asked to rate the subject's total improvement compared to their condition at baseline. The CGI-I uses a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved".
Time frame: End of Treatment (4-weeks of Treatment/Control)
User Satisfaction With The Smartpatch System at End of Treatment
Subjects completed the sponsor-developed Subject Satisfaction Survey at the End of Treatment (EOT) visit. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.
Time frame: End of Treatment (4-weeks of Treatment/Control)
User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment
Subjects completed the sponsor-developed Subject Satisfaction Survey at the end of the 12-week post-treatment period. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.
Time frame: 12-week post-treatment
Performance of the Smartpatch System
A sponsor-developed Clinician Satisfaction Survey was administered to the Investigator(s) at each site performing lead placement and included questions pertaining to use of the Smartpatch device as well as the overall impression of the therapy.
Time frame: At completion of study, approximately 2.5 years
Recruitment began in March 2013 and was concluded in May 2015. Subjects were screened for the study from the available pool of candidates who presented to the Investigators with shoulder pain following stroke.
| Milestone | Enrolled Subjects | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) |
|---|---|---|---|
| Started | 88 | 0 | 0 |
| Randomized | 46 | 0 | 0 |
| Full analysis set | 43 | 0 | 0 |
| Safety set | 41 | 0 | 0 |
| Per protocol set | 40 | 0 | 0 |
| Completed | 40 | 0 | 0 |
| Not completed | 48 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
| Withdrew: Screen failure | 39 | 0 | 0 |
| Withdrew: Pending prior to enrollment stop | 6 | 0 | 0 |
| Milestone | Enrolled Subjects | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) |
|---|---|---|---|
| Started | 0 | 31 | 15 |
| Full analysis set | 0 | 28 | 15 |
| Safety set | 0 | 28 | 13 |
| Per protocol set | 0 | 27 | 13 |
| Completed | 0 | 27 | 13 |
| Not completed | 0 | 4 | 2 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 |
| Withdrew: Screen failure | 0 | 3 | 0 |
A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as "please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours". BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at End of Treatment (EOT) was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for treatment was compared to the group mean of the medians scores for the control group at baseline and at EOT.
| scores on a scale | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) |
|---|---|---|
| Baseline diary score | 7.1 ± 1.5 | 6.6 ± 1.5 |
| EOT diary score | 4.1 ± 2.3 | 4.1 ± 3.1 |
| Change in pain intensity from baseline | 3.1 ± 2.3 | 2.5 ± 3.1 |
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
| device related adverse events | Smartpatch Treatment Group (Safety Set) | Smartpatch Control Group (Safety Set) |
|---|---|---|
| Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups | 16 | 3 |
The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes" within the last week. The mean of these seven scores will be calculated to obtain the pain interference score.
| scores on a scale | Smartpatch Treatment Group (Per Protocol Set) | Smartpatch Control Group (Per Protocol Set) |
|---|---|---|
| Baseline score | 4.8 ± 2.4 | 5.0 ± 2.0 |
| EOT score | 1.8 ± 1.8 | 2.6 ± 3.3 |
| Change in pain interference from baseline | 3.1 ± 2.2 | 2.4 ± 2.7 |
A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as "please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours". BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at 12 weeks post-treatment was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for 12 weeks post-treatment was compared to the group mean of the median scores for the control group at baseline.
| scores on a scale | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) |
|---|---|---|
| Baseline diary score | 7.1 ± 1.5 | 6.6 ± 1.5 |
| 12- weeks post-treatment diary score | 4.3 ± 2.9 | 4.3 ± 2.5 |
The Medical Outcomes Study Short Form (SF-36v2) was administered at clinic visits to assess the impact of peripheral nerve stimulation on the subject's health-related quality of life. The SF-36v2 is a generic health survey designed to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The 36 questions were grouped into two components: physical and mental. The survey was scored using norm-based scoring algorithm where a score of 0 indicates maximum disability and a score of 100 indicates no disability. Change in each component score was derived from End of Treatment score minus baseline score.
| scores on a scale | Smartpatch Treatment Group (Per Protocol Set) | Smartpatch Control Group (Per Protocol Set) |
|---|---|---|
| Physical Component Baseline score | 38.0 ± 8.9 | 35.4 ± 10.4 |
| Change in Physical Component score from baseline | 4.8 ± 7.0 | 3.5 ± 9.3 |
| Mental Component Baseline score | 54.3 ± 10.7 | 47.9 ± 9.5 |
| Change in Mental Component score from baseline | 4.1 ± 10.1 | 9.1 ± 13.2 |
A diary was used in the study to capture daily average shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 5 (BPI-5) and is stated as "please rate your pain by circling the one number that best describes your pain on the average". BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The mean scores were calculated for each diary period. The mean diary score at End of Treatment (EOT) was compared to the mean baseline diary score to calculate the change in pain intensity.
| scores on a scale | Smartpatch Treatment Group (Per Protocol Set) | Smartpatch Control Group (Per Protocol Set) |
|---|---|---|
| Baseline diary score | 5.2 ± 2.0 | 4.8 ± 1.7 |
| EOT diary score | 2.6 ± 1.8 | 2.4 ± 2.2 |
| Change in pain intensity from baseline | 2.7 ± 2.3 | 2.5 ± 2.3 |
The Patient Global Impression of Change (PGIC) scale was administered at EOT to assess subject perception of overall improvement and patient preferences. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved" relative to baseline.
| Participants | Smartpatch Treatment Group (Per Protocol Set) | Smartpatch Control Group (Per Protocol Set) |
|---|---|---|
| Very much worse | 0 | 0 |
| Much worse | 0 | 0 |
| Minimally worse | 0 | 2 |
| No change | 1 | 2 |
| Minimally improved | 11 | 5 |
| Much improved | 13 | 3 |
| Very much improved | 2 | 1 |
Subjects completed 7-day diaries, in which they listed all pain medications they took during the 7 days. A blinded third party medication committee reviewed medications collected for each 7-day diary period and scored medication changes, in comparison to the baseline diary medications as "no change" (no change in dosage or change is not clinically meaningful to impact pain outcomes), "increase" (clinically meaningful increase in medication that would impact pain outcomes), or "decrease" (clinically meaningful decrease in medication that would impact pain outcomes).
| Participants | Smartpatch Treatment Group (Per Protocol Set) | Smartpatch Control Group (Per Protocol Set) |
|---|---|---|
| Decrease in pain med usage compared to baseline | 6 | 4 |
| No change in pain med usage compared to baseline | 16 | 8 |
| Increase in pain med usage compared to baseline | 3 | 1 |
The Blinded Evaluator rated each subject enrolled at their site using a question adapted from the Clinical Global Impression (CGI) scale, known as the Clinical Global Impression-Improvement scale (CGI-I). For the CGI-I, a Blinded Evaluator was asked to rate the subject's total improvement compared to their condition at baseline. The CGI-I uses a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved".
| Participants | Smartpatch Treatment Group (Per Protocol Set) | Smartpatch Control Group (Per Protocol Set) |
|---|---|---|
| Very much worse | 0 | 0 |
| Much worse | 0 | 0 |
| Minimally worse | 0 | 1 |
| No change | 1 | 3 |
| Minimally improved | 11 | 4 |
| Much improved | 10 | 5 |
| Very much improved | 4 | 0 |
Subjects completed the sponsor-developed Subject Satisfaction Survey at the End of Treatment (EOT) visit. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.
| Participants | Smartpatch Treatment Group (Safety Set) | Smartpatch Control Group (Safety Set) |
|---|---|---|
| Reported study had positive impact on their life | 27 | 9 |
| Reported being satisfied with experience in study | 27 | 10 |
| Would recommend participation in study to a friend | 28 | 11 |
| Tolerated lead placement with no discomfort | 16 | 8 |
| Tolerated lead placement with some discomfort | 11 | 5 |
| Tolerated lead placement with a lot of discomfort | 1 | 0 |
Subjects completed the sponsor-developed Subject Satisfaction Survey at the end of the 12-week post-treatment period. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.
| Participants | Smartpatch Treatment Group (Safety Set) | Smartpatch Control Group (Safety Set) |
|---|---|---|
| Reported study had positive impact on their life | 27 | 11 |
| Reported being satisfied with experience in study | 26 | 11 |
| Would recommend participation in study to a friend | 28 | 13 |
| Tolerated lead placement with no discomfort | 20 | 9 |
| Tolerated lead placement with some discomfort | 7 | 4 |
| Tolerated lead placement with a lot of discomfort | 1 | 0 |
A sponsor-developed Clinician Satisfaction Survey was administered to the Investigator(s) at each site performing lead placement and included questions pertaining to use of the Smartpatch device as well as the overall impression of the therapy.
| Participants | Investigators |
|---|---|
| Agreed time to perform procedure was acceptable | 7 |
| Agreed that device components performed well | 6 |
| Agreed that patients tolerated the procedure well | 6 |
| Agreed that the Smartpatch System was easy to use | 7 |
| Liked the size, weight, & shape of the Stimulator | 7 |
| Agreed study beneficial for most of their patients | 5 |
Subjects who reported an reduction of at least 30% in either pain intensity or pain interference from baseline to End of Treatment (EOT) using the Brief Pain Inventory (BPI) Short Form. The pain intensity score is excerpted from BPI question 3, worst pain, taken from 7-day diaries. This scale ranges from 0 representing no pain to 10 representing worst pain. The median diary score at EOT was compared to the median baseline diary score to calculate the percentage of subjects who had at least a 30% reduction in pain intensity. Pain interference was assessed using BPI question 9. Subjects rated the degree to which their pain interfered with seven facets of daily life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes". The mean of these 7 scores was calculated to obtain the pain interference score. The score at EOT was compared to the baseline score to determine the percentage of subjects who had at least a 30% reduction in pain interference.
| Participants | Smartpatch Treatment Group (Per Protocol Set) | Smartpatch Control Group (Per Protocol Set) |
|---|---|---|
| Composite 30% Reduction in Pain Intensity or Pain Interference From Baseline to End of Treatment (EOT) | 25 | 8 |
The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes" within the last week. The mean of these seven scores was calculated to obtain the pain interference score. The score at End of Treatment (EOT) was compared to the baseline score to determine the percentage of subjects who had a clinically significant (30% or greater) reduction in pain interference.
| Participants | Smartpatch Treatment Group (Per Protocol Set) | Smartpatch Control Group (Per Protocol Set) |
|---|---|---|
| 30% Reduction in Pain Interference From Baseline to End of Treatment (EOT) | 24 | 7 |
Collected over Adverse events were collected over a period of 29 months (time from when the first subject was enrolled in April 2013 to when the last subject was completed in August 2015).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enrolled Subjects Who Did Not Receive the Study Device | 0/88 (0%) | 1/88 (1.1%) | 0/88 (0%) |
| Smartpatch Treatment Group (Safety Set) | 0/28 (0%) | 0/28 (0%) | 22/28 (78.6%) |
| Smartpatch Control Group (Safety Set) | 0/13 (0%) | 0/13 (0%) | 9/13 (69.2%) |
| Event | Enrolled Subjects Who Did Not Receive the Study Device | Smartpatch Treatment Group (Safety Set) | Smartpatch Control Group (Safety Set) |
|---|---|---|---|
| Focal seizure (occurred prior to receiving any intervention)Nervous system disorders | 1/88 | 0/28 | 0/13 |
| Event | Enrolled Subjects Who Did Not Receive the Study Device | Smartpatch Treatment Group (Safety Set) | Smartpatch Control Group (Safety Set) |
|---|---|---|---|
| Skin irritation/dermatitis from bandagesSkin and subcutaneous tissue disorders | 0/88 | 9/28 | 4/13 |
| Mild erythema or irritation at lead exit siteSkin and subcutaneous tissue disorders | 0/88 | 2/28 | 1/13 |
| PainNervous system disorders | 0/88 | 0/28 | 1/13 |
| Urinary Tract InfectionRenal and urinary disorders | 0/88 | 0/28 | 1/13 |
| New numbness to left lower extremityVascular disorders | 0/88 | 0/28 | 1/13 |
| Dizziness and headacheNervous system disorders | 0/88 | 0/28 | 1/13 |
| Lead barb retainedSkin and subcutaneous tissue disorders | 0/88 | 2/28 | 0/13 |
| Skin irritation/redness/or mild skin tears from Smartpatch PadSkin and subcutaneous tissue disorders | 0/88 | 2/28 | 0/13 |
| General malaise after procedureGeneral disorders | 0/88 | 1/28 | 0/13 |
| Mild bruising under lead connectorSkin and subcutaneous tissue disorders | 0/88 | 1/28 | 0/13 |
The full analysis set includes all randomized patients who continued to meet all eligibility criteria prior to the time of lead placement.
| Age, Continuous(years) | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) | Total |
|---|---|---|---|
| Mean | 57.2 ± 11.8 | 58.9 ± 9.8 | 57.8 ± 11.1 |
| Sex: Female, Male(Participants) | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) | Total |
|---|---|---|---|
| Female | 10 | 6 | 16 |
| Male | 18 | 9 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 0 | 3 |
| Not Hispanic or Latino | 25 | 15 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 1 | 11 |
| White | 15 | 11 | 26 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Type of stroke(Participants) | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) | Total |
|---|---|---|---|
| Hemorrhagic | 11 | 5 | 16 |
| Ischemic | 16 | 10 | 26 |
| Unknown/not collected | 1 | 0 | 1 |
| Time elapsed from stroke, years(years) | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) | Total |
|---|---|---|---|
| Mean | 5.1 ± 4.7 | 3.5 ± 2.8 | 4.5 ± 4.2 |
| Presence of shoulder subluxation(Participants) | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) | Total |
|---|---|---|---|
| Subluxation present | 23 | 11 | 34 |
| Subluxation absent | 5 | 2 | 7 |
| Beck Depression Inventory score(Beck Depression Score) | Smartpatch Treatment Group (Full Analysis Set) | Smartpatch Control Group (Full Analysis Set) | Total |
|---|---|---|---|
| Mean | 13.2 ± 9.0 | 17.6 ± 11.9 | 14.7 ± 10.1 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.