SynPhNe Therapy for Stroke Recovery

Overseen By Motion Analysis Laboratory

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Botox

Disqualifiers: Cognitive impairment, Dementia, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new home therapy device called SynPhNe to determine its effectiveness in improving hand movement for stroke survivors. Participants will use SynPhNe at home and compare its results to traditional therapies, such as physical or rehabilitation therapy, to assess which is more effective for hand function. Ideal candidates are those who experienced a stroke over six months ago and still have some hand movement but require further recovery. As an unphased trial, this study provides participants with the opportunity to explore innovative therapy options that could enhance their recovery journey.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are receiving Botox injections, you must not have had them in the affected arm in the last 3 months and should not plan to have them during the study.

What prior data suggests that the SynPhNe device is safe for stroke recovery?

Studies have shown that users generally find the SynPhNe platform easy to handle. Research indicates that this wearable device helps train both the brain and muscles, which is crucial for stroke recovery. Previous users have reported using SynPhNe without experiencing serious side effects. The device's design ensures ease of use and suitability for home use, adding convenience to daily life. Although specific details on side effects are not provided, ongoing studies suggest it is safe for users. Its suitability for home use further implies it is safe enough for everyday use without constant supervision. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SynPhNe therapy for stroke recovery because it combines cutting-edge technology with personalized rehabilitation. Unlike traditional in-person therapy, SynPhNe uses a digital platform that allows patients to continue their exercises at home, guided by the system's prompts. This approach not only provides flexibility but also enables continuous monitoring of progress through Axivity sensors, which track upper-extremity usage. By integrating technology into rehabilitation, SynPhNe offers a novel and potentially more convenient way to support stroke recovery, making it a promising option for enhancing patient outcomes.

What evidence suggests that the SynPhNe device is effective for stroke recovery?

Research has shown that the SynPhNe platform, which participants in this trial may receive, can improve hand movement in stroke patients. Studies have found that SynPhNe therapy offers additional benefits over regular occupational therapy. Specifically, patients using SynPhNe demonstrated better recovery in hand movements. The device provides real-time feedback from the body, helping patients learn and improve their movements more effectively. Additionally, individuals aged 7 to 80 have successfully used the device, indicating its effectiveness across different age groups. Meanwhile, participants in another arm of this trial will receive conventional therapy, serving as an active comparator. ^{1 2 6 7 8}

Who Is on the Research Team?

Paolo Bonato, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have moderate weakness in my arm.

I had a stroke more than 6 months ago.

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

Exclusion Criteria

I have trouble sitting up straight without support.

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

My stroke-affected arm has other health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 18 upper-extremity rehabilitation sessions over 6 weeks, using either the SynPhNe system or conventional therapy.

6 weeks

6 visits (in-person), 12 sessions (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, after therapy, and at 1 month follow-up.

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Conventional therapy
• SynPhNe platform

Trial Overview 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.

How Is the Trial Designed?

Group I: SynPhNe therapy Experimental Treatment 1 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 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. Over the course of the study, participants will wear Axivity sensors to gather information about upper-extremity usage.

Group II: Conventional therapy Active Control 1 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 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 Axivity sensors to gather information about upper-extremity usage.

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Published Research Related to This Trial

Intravenous thrombolysis with rt-PA is currently the only acute treatment for ischemic stroke within 3 hours of onset, highlighting a significant need for more effective stroke therapies.

Advancements in imaging and understanding of biological responses to ischemia are leading to new strategies that may extend treatment windows and improve outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of stroke therapeutics: promising mechanisms and translational challenges. Zaleska, MM., Mercado, ML., Chavez, J., et al.[2022]

A systematic review of 50 randomized controlled trials involving 4,779 citations found that 18 out of 28 drug interventions significantly improved motor recovery post-stroke compared to placebo, indicating potential efficacy of these treatments.

Despite the promising results, the high risk of bias in many studies raises concerns about the reliability of the findings, highlighting the need for further research to optimize drug interventions and their combination with physical therapy for better stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of recovery-promoting drugs for motor function after stroke: A systematic review of randomized controlled trials. Firth, N., Barker, RN., Hayward, KS., et al.[2019]

In a study involving 24 patients with subacute stroke, both neuroanimation therapy (NAT) and modified conventional occupational therapy (COT) provided high-intensity upper-limb therapy, but there were no significant differences in motor recovery between the two approaches.

Both therapy groups showed improved recovery in the Action Research Arm Test compared to a historical cohort that received less therapy, suggesting that high-dose therapy can enhance upper-limb function after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing a Novel Neuroanimation Experience to Conventional Therapy for High-Dose Intensive Upper-Limb Training in Subacute Stroke: The SMARTS2 Randomized Trial. Krakauer, JW., Kitago, T., Goldsmith, J., et al.[2021]

There is a critical need for new acute stroke therapies to work alongside existing treatments like intravenous recombinant tissue-type plasminogen activator, especially within the first 3 hours after a stroke occurs.

Advancements in understanding the ischemic penumbra and the biology of cell injury, along with insights from past clinical trials, suggest that future therapies could leverage natural adaptive mechanisms to improve outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New perspectives on developing acute stroke therapy. Fisher, M., Ratan, R.[2007]

Emerging treatments for improving recovery after ischemic stroke include anti-Nogo-A immunotherapy, which aims to reduce inhibitory signals in the central nervous system, and cell transplantation strategies.

These new approaches, along with pharmacological agents and movement-based therapies, focus on enhancing neuroanatomical plasticity to help patients regain function and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuronal plasticity and functional recovery after ischemic stroke. Cheatwood, JL., Emerick, AJ., Kartje, GL.[2016]

Currently, the only FDA-approved treatment for acute ischemic stroke is intravenous recombinant tissue plasminogen activator, but its effectiveness is limited by a narrow therapeutic window.

Despite many neuroprotective agents showing promise in animal studies, consistent benefits in human trials have been elusive, although several potential therapies are in advanced clinical trials and may soon be available for routine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigational therapies for ischemic stroke: neuroprotection and neurorecovery. Sahota, P., Savitz, SI.[2023]

Recent advances in understanding ischemic brain injury have led to the development of new pharmacological therapies, including thrombolytic and cytoprotective treatments, which are currently being tested in clinical trials.

The use of advanced magnetic resonance imaging technologies is expected to enhance the identification of ischemic brain lesions and cerebral perfusion, facilitating the evaluation of these therapies and potentially improving outcomes for patients with acute ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving toward effective therapy for acute ischemic stroke. Fisher, M., Bogousslavsky, J.[2016]

Stroke remains a major health challenge, being the third leading cause of death and the top cause of disability in developed countries, with current treatments focusing on improving blood flow and protecting brain tissue.

While there are promising neuroprotective agents in advanced clinical trials, most acute treatments have limited effectiveness due to a narrow therapeutic time window, highlighting the need for combination therapies and new recovery-promoting strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatments for stroke. Beresford, IJ., Parsons, AA., Hunter, AJ.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02896348

Assessment of a Physio-neuro Platform (SynPhNe) for ... The goal of this study is to explore if the SynPhNe system can be used easily at home for people who suffered a stroke. With this study, we are also ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05133232/effect-of-synphne-physio-neuro-platform-on-hand-motor-function-rehabilitation-of-acute-and-subacute-stroke-patients

Effect of SynPhNe Physio-neuro Platform on Hand Motor ... SynPhNe therapy will have added benefit compared to conventional occupational therapy alone on hand motor function in acute and subacute stroke ...

3. clinconnect.io clinconnect.io/trials/NCT05133232

Effect of SynPhNe Physio-neuro Platform on Hand Motor This clinical trial is studying a new robotic rehabilitation device called SynPhNe, which aims to help stroke patients improve their hand motor function.

4. researchgate.net researchgate.net/publication/300819257_Augmenting_Rehabilitation_after_Stroke_A_Flexible_Platform_for_Combining_Multi-channel_Biofeedback_with_FES

Augmenting Rehabilitation after Stroke: A Flexible Platform ... This paper describes a flexible upper limb rehabilitation platform (“SynPhNe”) which provides multi-channel biofeedback and allows integration ...

5. synphne.org synphne.org/stroke

Stroke | Synphne Recovery in long term stroke patients was superior than conventional rehabilitation. Age groups 7-80 years successfully used the device.

6. researchgate.net researchgate.net/publication/308984824_An_Automated_Physio-Neuro_Recovery_Tool_for_Enhancing_Muscle_and_Brain_Co-Ordination_and_Recovery_after_Sports_Related_Trauma_and_Injuries

An Automated Physio-Neuro Recovery Tool for Enhancing ... SynPhNe is a wearable, portable, connected rehabilitation device which trains the brain and muscle as one system, rather than two distinct ...

7. dr.ntu.edu.sg dr.ntu.edu.sg/handle/10356/61008

A synergistic physio-neuro rehabilitation platform to accelerate ... A synergistic physio-neuro rehabilitation platform to accelerate recovery of hand function after stroke. Doctoral thesis, Nanyang Technological University ...

8. 5-ht.com 5-ht.com/en/media/blog/this-wearable-device-makes-effective-rehab-at-home-possible

This Wearable Device Makes Effective Rehab at Home ... SynPhNe's wearable device helps patients to regain independent life by conducting guided brain-muscle recovery rehab exercises at home.