Neuro-Intermuscular Coordination Enhancement for Stroke

(NICE Trial)

JR
Overseen ByJinsook Roh, PhD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Houston
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 rehabilitation method called NICE Rehabilitation Through Human-Machine Interaction, which uses technology to help stroke patients regain muscle control. The researchers aim to determine if this method can enhance recovery and quality of life for stroke survivors. Participants will engage in two types of exercises: one targets muscle strengthening, while the other improves muscle coordination. Individuals who have had a stroke and are not receiving certain treatments for their affected arm may qualify for this trial. As an Early Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to experience this innovative approach firsthand.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you should not have received botulinum toxin on the impaired arm within the last 3 months.

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

Research has shown that technologies used in stroke rehabilitation, such as those involving human-machine interaction, are generally safe and easy to use. For instance, one study tested a similar system with a stroke patient who experienced no serious side effects. Another review highlighted the safety of using robotic devices and virtual reality in stroke rehab, particularly when designed to be user-friendly. These technologies are built to be stable and secure, reducing risks during use. Although specific data on side effects for this particular treatment is limited, the early phase of the trial will focus on assessing its safety in humans.12345

Why are researchers excited about this trial?

Researchers are excited about the NICE Rehabilitation treatment because it uses human-machine interaction to enhance neuro-intermuscular coordination for stroke recovery. Unlike traditional rehabilitation, which often focuses on repetitive physical exercises, this method involves interactive tasks where patients control a cursor on a screen through muscle contractions. This innovative approach not only targets muscle strength but also improves coordination by integrating real-time feedback from electromyographic responses. By engaging multiple muscles in a coordinated manner, it has the potential to accelerate recovery and improve precision in movements, offering new hope for stroke survivors.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

This trial compares two types of rehabilitative training for stroke patients. One arm involves neuromuscular coordination-guided rehabilitative training, where participants perform tasks using isometric contractions of multiple muscles, guided by electromyographic (EMG) responses. Research has shown that this training can improve muscle coordination in stroke patients by recording muscle activity to guide exercises, potentially enhancing arm movement and reducing motor skill difficulties. The other arm involves force strengthening-guided rehabilitative training, where participants generate isometric force to move a cursor on a screen, aiming to enhance muscle strength and coordination.678910

Who Is on the Research Team?

JR

Jinsook Roh, PhD

Principal Investigator

University of Houston

Are You a Good Fit for This Trial?

This trial is for adults aged 21-80 who have had a stroke (either ischemic or hemorrhagic) and have some arm movement but not severe spasticity. People can't join if they have major arm joint problems, significant memory/thinking issues, other nerve diseases, numbness in their arms, or are pregnant.

Inclusion Criteria

I have had a stroke in the past.
I am between 21 and 80 years old.
I have not had botulinum toxin injections in my affected arm in the past 3 months.
See 1 more

Exclusion Criteria

I have a bone or joint problem in my arms or hands.
I have cognitive issues that make it hard to understand or complete study tasks.
History of another neurologic disease
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either neuromuscular-coordination guided exercise (NICE) or force-guided exercise for rehabilitation

6 weeks
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Post-training assessments at 6, 10, and 18 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NICE Rehabilitation Through Human-Machine Interaction

Trial Overview

The study compares two types of rehab training for stroke recovery: one uses EMG signals to guide muscle coordination with human-machine interaction (NICE), and the other focuses on strengthening muscles. Participants are assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Neuromuscular coordination enhancement (NICE) interventionExperimental Treatment1 Intervention
Group II: EMG-amplitude biofeedback exerciseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials
155
Recruited
48,600+

The University of Texas Health Science Center, Houston

Collaborator

Trials
974
Recruited
361,000+

TIRR Memorial Hermann

Collaborator

Trials
16
Recruited
4,700+

Citations

EMG-guided Neuro-Intermuscular Coordination ...

This study, in total, 38 chronic stroke survivors will be randomly assigned into two rehabilitation strategies either neuromuscular-coordination ...

EMG-guided human–machine interaction training develops ...

EMG-guided human–machine interaction training develops new intermuscular coordination patterns in stroke: a pilot study ... in stroke patients after robot-aided ...

EMG-guided Neuro-Intermuscular Coordination Enhancement ...

This study, in total, 38 chronic stroke survivors will be randomly assigned into two rehabilitation strategies either neuromuscular-coordination ...

EMG-guided Neuro-Intermuscular Coordination ...

This is an early-phase clinical trial where behavioral intervention through human-machine interaction will be performed on stroke survivors.

Generalizability of neuromuscular coordination in the human ...

These results highlight the importance of developing novel stroke rehabilitation strategies that aim at improving intermuscular coordination ...

Stroke Rehabilitation, Novel Technology and the Internet of ...

This manuscript reviews emerging rehabilitation technologies such as robotic devices, virtual reality, brain–computer interfaces and ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40611303/

Exploratory development of human-machine interaction ...

The proposed system is validated through a proof-of-concept study on a subject who underwent a craniotomy for a hemorrhagic stroke, ...

Post-Stroke Rehabilitation Using Collaborative Robotic Therapy

The aim is to create an appealing human-machine interface from which a stroke patient can select exercises. Additionally, the patient should have the ...

Extended Interviews with Stroke Patients Over a Long-Term ...

We conducted 29 interviews with 16 stroke patients who underwent a long-term rehabilitation process, assisted by either a SAR or a computer interface.

Technology Acceptance and Usability of a Therapy System ...

Here, we report on a new and different technological approach to support rehabilitation post-stroke. By making use of humanoid robot technology ...