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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.
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have moderate weakness in my arm.
Select...
I can move 2 fingers in my hand and my elbow without much pain.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Box and Block test
Fugl-Meyer Upper Extremity
Wolf Motor Function Test (Upper Extremity)
Secondary outcome measures
EQ5D questionnaire
Jamar dynamometer
Modified Ashworth Scale
+3 moreOther outcome measures
Device satisfaction feedback questionnaire (only for intervention group)
Goniometry - Active Range of Motion
Manual Muscle Testing (Kendall)
+3 moreTrial 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.
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Who is running the clinical trial?
Spaulding Rehabilitation HospitalLead Sponsor
135 Previous Clinical Trials
11,015 Total Patients Enrolled
25 Trials studying Stroke
969 Patients Enrolled for Stroke
Paolo Bonato, PhDPrincipal InvestigatorSpaulding Rehabilitation Hospital
22 Previous Clinical Trials
690 Total Patients Enrolled
10 Trials studying Stroke
283 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have trouble sitting up straight without support.I have moderate weakness in my arm.I have been diagnosed with a neurological condition, but it's not a stroke.My stroke-affected arm has other health issues.I cannot provide or give access to brain imaging of my stroke.I haven't had Botox in my arm in the last 3 months and don't plan to until the study ends.My arm weakness does not severely limit my ability to participate in therapy.You have high muscle tone, which is shown by a score of 3 or higher on the Modified Ashworth Scale.I have had a seizure or been diagnosed with a seizure disorder in the last 6 months.You have trouble understanding and following instructions, and have difficulty paying attention for more than 10 minutes.My doctor expects I have less than a year to live due to my illness.I had a stroke more than 6 months ago.You have trouble understanding and following the treatment instructions due to difficulty with language.You have been diagnosed with dementia before.I am currently in a therapy program for my arm or hand.I experience severe pain in my arm affected by stroke.I can move 2 fingers in my hand and my elbow without much pain.
Research Study Groups:
This trial has the following groups:- Group 1: SynPhNe therapy
- Group 2: Conventional therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the ultimate objective of this research endeavor?
"This research is focused on the Fugl-Meyer Upper Extremity score, which will be assessed at the outset of the experiment, after seven weeks and a month following completion. The Modified Ashworth Scale (ranging from 0 to 4), EQ5D questionnaire (for assessing quality of life) and Visual Analogue Scale for Pain (from 0 to 10) serve as secondary objectives in this trial."
Answered by AI
Does this trial accept participants of all ages, or are there age restrictions?
"This clinical trial requires applicants to be between 21 and 80 years of age. There are 44 studies that cater to participants under 18, while a total 1028 medical trials have been designed for patients over 65."
Answered by AI
Who fulfills the eligibility criteria for inclusion in this clinical trial?
"Individuals between 21 and 80 years of age who have been diagnosed with hemiparesis are eligible to apply for this medical trial. The goal is to recruit 40 patients in total."
Answered by AI
Have recruitment efforts for this clinical trial commenced yet?
"According to clinicaltrials.gov, this clinical trial is not actively searching for participants as the last edited date was October 25th 2022. However, there are 1070 other medical studies that currently require new recruits at this time."
Answered by AI
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