SynPhNe platform for Stroke

Phase-Based Estimates
1
Effectiveness
1
Safety
Spaulding Rehabilitation Hospital, Boston, MA
Stroke+2 More
SynPhNe platform - Device
Eligibility
18+
All Sexes
Eligible conditions
Stroke

Study Summary

Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors

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Eligible Conditions

  • Stroke
  • Paresis
  • Hemiparesis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether SynPhNe platform will improve 3 primary outcomes, 6 secondary outcomes, and 6 other outcomes in patients with Stroke. Measurement will happen over the course of Changes from baseline scores at Baseline, at 7 weeks and at one month follow-up.

Week 7
Fugl-Meyer Upper Extremity
Week 7
Box and Block test
Week 7
EQ5D questionnaire
Goniometry - Active Range of Motion
Jamar dynamometer
Manual Muscle Testing (Kendall)
Modified Ashworth Scale
Motor Activity Log
Systolic and Diastolic Blood Pressure
Visual Analogue Scale for Pain
WHO-ICF problem solving form
Wolf Motor Function Test (Upper Extremity)
Scores at 7 weeks
Device satisfaction feedback questionnaire (only for intervention group)
Number of issues encountered with the device and/or software (only for intervention group)
Number of sessions completed (only for intervention group)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Conventional therapy
SynPhNe therapy

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. SynPhNe Platform is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

SynPhNe therapy
Device
Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes with SynPhNe platform, over 6 weeks. The sessions will emphasize on the wrist and fingers movements, including functional activities. During week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. Over the next 4 to 5 weeks, 10 sessions following exercises prompted by the SynPhNe system will be done unsupervised at home (or under limited supervision at the hospital), 2 sessions will be done at Spaulding Rehabilitation Hospital to review exercises with the SynPhNe system.
Conventional therapy
Other
Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes under therapist supervision over two weeks at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The sessions will emphasize on the wrist and fingers movements, including functional activities. During week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The remaining 10 sessions will be done unsupervised at home, over approximately 4 weeks, and following the therapist home treatment plan. Over that time, 2 visits to Spaulding Rehabilitation will be made to review home treatment plan. Over the course of the study, participants will wear GeneActiv sensors to gather information about upper-extremity usage.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: scores at 7 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly scores at 7 weeks for reporting.

Who is running the study

Principal Investigator
P. B.
Paolo Bonato, PhD
Spaulding Rehabilitation Hospital

Closest Location

Spaulding Rehabilitation Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A person who has had a stroke within the past 6 months is not eligible to participate in this study. show original
The person has some difficulty using their arm and hand, with the initial score on the Upper Extremity Fugl-Meyer Assessment between 21 and 55 out of 66. show original
The person has the ability to extend their fingers at least 10 degrees and have pain-free range of motion in at least 50% of the joints below the elbow. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get stroke a year in the United States?

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About 1.6 million cases are diagnosed with stroke a year in the United States. The rate of stroke is high in both men and women.

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What causes stroke?

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Stroke may have more than one cause, but cardio-embolic stroke represents 75% of cases. The pathogenesis can be related to atheroma, hypertension and heart failure. Risk factors are age, diabetes, family history (especially first degree relatives). Patients with rheumatic heart disease or mitral stenosis are at higher risk of stroke and should be investigated with echocardiography and cardio-thrombography.

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What is stroke?

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While stroke, particularly transient ischemic attack, remains a leading cause of death globally, it accounts for only 1% of global deaths in the United States. Stroke occurs spontaneously and can occur at any age. In most cases, symptoms of stroke include new focal deficits or a change in the character of a preexisting deficit. Most strokes are due to atrial fibrillation or occlusion of a large blood vessel, typically the anterior cerebral artery. Stroke also is a manifestation of vascular diseases, particularly atherosclerosis. Strokes occur in all regions of the world and every socioeconomic group. Risk factors for stroke include hypertension, diabetes mellitus, and family history of stroke.

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Can stroke be cured?

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Patients who are stroke-free after a car crash should keep a diary of the dates of the car accident and visits to the doctor. In patients with stroke and car accident, car accident should be the first priority. Most strokes that occur in cars are controllable, and the time to reach the hospital or other medical facility should allow treatment to be completed. Patients with stroke and car accident must be seen within 24 hours; and the possibility of other strokes or car accidents in the future could be prevented. Most car crashes occur in the wintertime in the US, and the patient should be taken to a hospital as soon as possible.

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What are the signs of stroke?

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A thorough history is essential, including information on symptoms and signs of stroke, such as dizziness, slurred speech, weakness extremities, numbness, aphasia or visual symptoms. There is no one single sign of stroke (stroke-like illness) that is diagnostic. In the event of a suspected stroke, computed tomography, magnetic resonance imaging with and without contrast and diffusion- weighted imaging should be performed if available. An examination of both arms and legs is mandatory, and it includes looking for hemiparesis in the face, arm, finger and leg.

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What are common treatments for stroke?

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Stroke recovery involves physical, social, occupational and psychological recovery. The most common treatments for stroke are rest and exercise (aerobic training in particular), medication, therapy and counseling and home based service. The goal for stroke rehabilitation is tailored to meet patient's needs and to incorporate the individual's goals and motivation. A multi-disciplinary stroke team is essential to facilitate stroke recovery.

Unverified Answer

What does synphne platform usually treat?

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A very small number of patients can be treated by our team and with the available technology. We can not determine the validity of a certain synphne therapy, as there are many possible causes for symptom improvement, and also because synphne is in our opinion a very simplistic approach to the complex and multifaceted processes that occur during stroke recovery. The most promising therapy may be in very specific cases. We’re waiting for further evidence. The most difficult thing to treat is the most difficult stroke.

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Is synphne platform safe for people?

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A randomized controlled trial comparing Synphne to conventional treatment yielded similar results, indicating that Synphne is safe for people treated for minor injuries. The only real difference between Synphne and the control group may be in patients with multiple minor injuries to the upper limb, where the patients did not receive treatment on those sides as this may have led to an increased incidence of post amputation complications. Thus, for people who have sustained multiple minor upper limb injuries to not have their arm supported, this study would suggest that Synphne is a safer alternative to conventional treatment, as it causes no further harm.

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Has synphne platform proven to be more effective than a placebo?

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An eight-week treatment with Synphne 50 and Synphne 50 + L-Depot with placebo in patients presenting with symptoms of osteoarthritis of the knee did not improve knee function. It was superior to placebo. Synphne 50 and Synphne 50 + L-Depot produced improvements in pain and function.

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What are the common side effects of synphne platform?

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The present data suggest that the synphne platform is clinically safe for use. The major concerns reported are diarrhea and nasogastric tube placement. It should be remembered that the majority of the patients were in a non-specific (non-serious) state of illness prior to hospital admission, which may not be a true reflection of the actual rate of side effects. The current protocol provides an acceptable level of safety assurance for patients who are hospitalized because they are admitted with new or chronic manifestations of disease.

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What is the primary cause of stroke?

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The predominant cause of stroke in our region is stroke due to atherosclerosis of the cardio cerebral artery. Other factors like hypertension, diabetes, hyperlipoproteinemia and hypercholesterolemia were also prevalent in a small percentage of population. We can control the other risk factors to prevent the occurrence of stroke, therefore, stroke in the region may be prevented.

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How does synphne platform work?

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Data from a recent study have demonstrated that synphne engines display an overall improved fuel economy and carbon dioxide emission at low and medium power output. This implies that synphne can be a suitable design for use in large-scale, real-world vehicle operating environments. We believe our model is the first one developed and implemented to analyse the performance of synphne engines.

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