4 Participants Needed

Functional Training for Stroke Rehabilitation

CK
TE
Overseen ByThomas E Augenstein, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people regain arm and hand movement after a stroke. It combines special devices with gentle nerve stimulation (Functional Training with SepaRRo and NeuRRoFES) to assess their impact on rehabilitation. Participants will undergo this therapy several times a week for a few weeks. It targets individuals who have experienced a specific type of stroke, retaining some arm movement but without major sensory or balance issues. As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation techniques that could enhance recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for stroke rehabilitation?

Research shows that using the SepaRRo and NeuRRoFES devices for stroke recovery remains in the early stages. Specific safety information from studies is not yet available, leaving unclear reports on how well people tolerate these devices or if any side effects exist.

The trial is marked as "Not Applicable" in terms of phase, indicating that the research focuses on evaluating the devices' functionality and potential applications rather than proving safety. Consequently, sufficient safety information for these devices is not yet available.

These devices aim to aid arm and hand recovery by using tools that do not require active movement, along with a method to stimulate muscles without surgery. While this approach appears promising, prospective participants should consult the study team about possible risks. The team can provide more detailed information on what to expect.12345

Why are researchers excited about this trial?

Researchers are excited about the treatments SepaRRo and NeuRRoFES for stroke rehabilitation because they offer a novel approach to recovery. Unlike traditional therapies, which often focus on passive exercises or medications, SepaRRo and NeuRRoFES use robotic intervention and Functional Electrical Stimulation (FES) to actively engage and stimulate the upper extremities. This combination aims to enhance muscle re-education and improve motor function more effectively. Additionally, these treatments can be tailored in frequency and duration, potentially leading to faster and more personalized rehabilitation outcomes.

What evidence suggests that this novel approach is effective for stroke rehabilitation?

Studies have shown that functional training can help stroke survivors enhance their physical abilities and quality of life. This training includes high-energy activities, proving more effective than traditional methods. In this trial, participants will undergo upper extremity rehabilitation using SepaRRo and NeuRRoFES, which involves simple devices and gentle electrical stimulation. Research suggests that this approach aids arm and hand recovery, showing promise in helping stroke patients regain movement and function. Overall, these findings support the potential effectiveness of this new training method in stroke rehabilitation.36789

Who Is on the Research Team?

CK

Chandramouli Krishnan, PT, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 to 75 who have had a stroke confirmed by imaging or clinical criteria, without major sensory deficits or severe joint limitations. It's not suitable for those with pacemakers, recent fainting spells, bilateral strokes, cognitive impairments (low scores on mental exams), severe communication difficulties, unresponsive muscles due to nerve damage, pregnancy intentions, skull fractures/head injuries in the recent past, seizures despite medication, metal implants in the skull or uncontrolled diabetes/hypertension.

Inclusion Criteria

No major deficits of sensation or proprioception
I am between 18 and 75 years old.
Ischemic or hemorrhagic stroke confirmed by CT, MRI, or clinical criteria

Exclusion Criteria

My joint movement is severely limited, affecting tests.
Have cardiac pacemakers
I have had several fainting spells recently.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive upper extremity rehabilitation using SepaRRo and NeuRRoFES 2-5 times per week

2-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Functional Training with SepaRRo and NeuRRoFES
Trial Overview The study tests a new rehabilitation method combining passive robotic devices (SepaRRo) with electrical muscle stimulation technology (NeuRRoFES) for improving arm function after a stroke. The goal is to see if this combination therapy is practical and effective.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Robotic InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Citations

Interventions to Improve Movement and Functional Outcomes ...Recent systematic reviews have concluded that cardiorespiratory training and exercise improve disability during or after usual stroke care [ ...
Functional Training with SepaRRo and NeuRRoFES in Stroke ...The purpose of this study is to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive ...
Postacute Rehabilitation Impact on Functional Recovery ...This study aimed to examine the impact of postacute rehabilitation duration on the outcome of functional recovery and patients' quality of life ...
Functional Exercise and Physical Fitness Post StrokeBoth groups improved functional activity up to six months which then stabilized up to twelve months to decline somewhat at thirty-six months after stroke.
High-Intensity Functional Activities Specific Training (FAST ...High-intensity functional training leads to greater improvements in physical performance and quality of life in stroke survivors compared with ...
Exploring Passive Robotic Devices for Stroke Rehabilitation: A New ...The University of Michigan has officially initiated this study to assess the use of SepaRRo and NeuRRoFES devices for stroke rehabilitation. The trial ...
Passive Robots for Stroke Rehabilitation: A Feasibility StudyThe study team has not published outcome measurements, participant flow, or safety data for this trial yet. ... Functional Training with SepaRRo ...
Effects of Rehabilitation Robot Training on Physical ...Based on these results, rehabilitation robotic training resulted in significant improvements in physical function, functional recovery, and ...
Evaluating core stability training-based combination therapies ...This study aims to identify the optimal core stability training combination for treating lower extremity dysfunction in stroke patients by ...
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