RecruitingNCT07218276ClinicalTrials.gov record

Passive Robots for Stroke Rehabilitation: A Feasibility Study

Stroke

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - 75 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 4 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The purpose of this study is to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive neuromuscular stimulation for upper extremity rehabilitation after stroke.

Read the full description

About 800,000 individuals suffer from a stroke every year in the United States. The majority of stroke survivors often experience lingering deficits in upper extremity function. High-end robotic devices can improve outcomes and clinical productivity; however, these devices are expensive and bulky, making them not practical for many clinical or home environments. This study aims to evaluate the feasibility of low-cost non-motorized devices for stroke rehabilitation in a long-term intervention. The intervention will involve training with a table-top, semi-passive (i.e., no motors) exercise equipment called SepaRRo and commonly-used neuromuscular stimulation. The stimulation will be provided during functional activities using a custom controller (NeuRRoFES) to trigger stimulation. These instruments are designed to provide flexible, compliant assistance/resistance to improve upper extremity function and can be used in a home setting. The study will measure technical feasibility (e.g., qualitative survey, adherence, time on task, retention, ability to perform tasks) as well as clinical feasibility (i.e., changes in biomechanical, neurophysiological, and functional measures) of an intervention with these devices in stroke survivors. The findings aim to support the development of affordable, home-use rehabilitation systems for stroke patients.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Age 18 to 75 years;
Ischemic or hemorrhagic stroke confirmed by CT, MRI, or clinical criteria;
No major deficits of sensation or proprioception;

Exclusion Criteria:

Bilateral stroke
Unable to think clearly and remember (Mini-Mental State Exam score \< 22 and miniMOCA \< 8);
Uncontrolled Diabetes or Hypertension;
Severe limitations of joint range of motion that will lead to inability of testing
Severe spasticity and joint contractures that will lead to inability of testing
Complete paresis with no possible movements
Severe aphasia
Any other medical condition that will significantly impact the study results
Unable to obtain reliable motor evoked potentials
Are pregnant or are actively trying to conceive
Have a recent history of repeated fainting spells or syncope.
Have a recent history of seizure (epilepsy) while on anti-seizure medication
Have a recent history of skull fracture/head injury
Have metal implants in the skull
Have cardiac pacemakers

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

Robotic Intervention

Participants will receive upper extremity rehabilitation using SepaRRo and NeuRRoFES 2-5 times per week for 2-6 weeks

Device: Functional Training with SepaRRo and NeuRRoFES

Functional Training with SepaRRo and NeuRRoFES DEVICE

Participants will perform functional movements (e.g., reach for targets) with their extremities. During movements, the devices will be used to assist or resist their motion. Participants may receive biofeedback of their movements to better engage them in training. Participants may receive assistance from the devices (including neuromuscular stimulation) and/or their less-impaired limb.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Device Survey For Feasibility

Time frame: Post-intervention (immediately following last session of intervention)

Subjective feedback regarding feasibility of the device for training

Other measures

Retention

Time frame: Post-intervention (immediately following last session of intervention)

Measure of how many participants completed intervention

Adherence

Time frame: Post-intervention (immediately following last session of intervention)

Measure of percentage of sessions completed

Upper extremity Fugl-Meyer Score

Time frame: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively.

Changes in upper extremity Fugl-Meyer score from before the intervention (from baseline) to after its completion using publicly available scoring sheets. The Fugl-Meyer score is a measure of functional impairment and runs from 0 to 66 points, with higher numbers reflecting better outcome.

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