← Back to Search

Behavioural Intervention

SynPhNe Therapy for Stroke Recovery

N/A

Waitlist Available

Led By Paolo Bonato, PhD

Research Sponsored by Spaulding Rehabilitation Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate upper-extremity hemiparesis (initial score on the Upper Extremity Fugl-Meyer Assessment between 21 and 55 out of 66)

Ability to extend at least 2 fingers in the affected hand 10 degrees at any joint with pain-free passive range of motion at least 50% in all joints below the elbow.

Must not have

Poor sitting balance (as assessed with the Berg Balance Test)

Previous diagnosis of neurological diseases other than Stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes from baseline scores at baseline, at 7 weeks and at one month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device that may help improve hand function for people who have had a stroke.

Who is the study for?

This trial is for chronic stroke survivors who had a stroke at least 6 months ago and have moderate hand weakness. They must be able to move two fingers slightly and follow instructions. People with severe cognitive issues, current therapy, recent Botox in the arm, poor balance, severe communication problems, high muscle tone or other major health issues can't join.

What is being tested?

The study tests the SynPhNe platform—a device for home-based hand function training—against standard care alone. It aims to see if using SynPhNe along with some conventional therapy sessions is better at improving motor skills in the affected hand of stroke patients.

What are the potential side effects?

While specific side effects are not listed for this trial, typical risks may include discomfort from wearing the device or fatigue from exercises. The study will monitor participants closely to ensure safety during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have moderate weakness in my arm.

Select...

I can move 2 fingers in my hand and my elbow without much pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have trouble sitting up straight without support.

Select...

I have been diagnosed with a neurological condition, but it's not a stroke.

Select...

My stroke-affected arm has other health issues.

Select...

I cannot provide or give access to brain imaging of my stroke.

Select...

I haven't had Botox in my arm in the last 3 months and don't plan to until the study ends.

Select...

I have had a seizure or been diagnosed with a seizure disorder in the last 6 months.

Select...

My doctor expects I have less than a year to live due to my illness.

Select...

I experience severe pain in my arm affected by stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes from baseline scores at baseline, at 7 weeks and at one month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes from baseline scores at baseline, at 7 weeks and at one month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from baseline scores at baseline, at 7 weeks and at one month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Box and Block test

Fugl-Meyer Upper Extremity

Wolf Motor Function Test (Upper Extremity)

Secondary study objectives

EQ5D questionnaire

Jamar dynamometer

Modified Ashworth Scale

+3 more

Other study objectives

Device satisfaction feedback questionnaire (only for intervention group)

Goniometry - Active Range of Motion

Manual Muscle Testing (Kendall)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SynPhNe therapyExperimental Treatment1 Intervention

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.

Group II: Conventional therapyActive Control1 Intervention

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.

0 / 10Eligibility criteria met