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Passieve robots voor revalidatie na een beroerte: een haalbaarheidsstudie

7 november 2026 bijgewerkt door: Chandramouli Krishnan, University of Michigan

Passieve robots voor revalidatie na een beroerte

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

4

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Chandramouli Krishnan, PT, PhD
  • Telefoonnummer: 7349364031
  • E-mail: mouli@umich.edu

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48108
        • Werving
        • University of Michigan - NeuRRo Lab
        • Hoofdonderzoeker:
          • Chandramouli Krishnan, PT PhD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Toestel Haalbaarheid
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Robotic Intervention

Participants will receive upper extremity rehabilitation using SepaRRo and NeuRRoFES 2-5 times per week for 2-6 weeks
Apparaat: Functional Training with SepaRRo and NeuRRoFES

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Device Survey For Feasibility
Tijdsspanne: Post-intervention (immediately following last session of intervention)

Subjective feedback regarding feasibility of the device for training
Post-intervention (immediately following last session of intervention)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Retention
Tijdsspanne: Post-intervention (immediately following last session of intervention)

Measure of how many participants completed intervention
Post-intervention (immediately following last session of intervention)
Adherence
Tijdsspanne: Post-intervention (immediately following last session of intervention)

Measure of percentage of sessions completed
Post-intervention (immediately following last session of intervention)
Upper extremity Fugl-Meyer Score
Tijdsspanne: 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.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively.
Reachable workspace
Tijdsspanne: 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 reachable workspace from before the intervention (from baseline) to after its completion). The reachable workspace area will be measured with SepaRRo obtained from optical encoders mounted in the device.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Voluntary hand opening
Tijdsspanne: 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 voluntary ability to open the hand from before the intervention (from baseline to after its completion). Voluntary hand opening will be measured with motion capture equipment.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Action Research Arm Test Score
Tijdsspanne: 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 the Action Research Arm Test Score from before the intervention (from baseline) to after its completion using publicly available scoring sheets. The Action Research Arm Test is a measure of arm functional ability and runs from 0 to 57 points, with higher numbers reflecting better outcome.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Box and Block (BBT)
Tijdsspanne: 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 functional measure of arm disability (BBT) from before the intervention (from baseline) to after its completion using publicly available scoring sheets.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Hand Strength
Tijdsspanne: 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 force produced by the hand from before the intervention (from baseline) to after its completion as measured by force production recorded with a dynamometer
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Arm strength
Tijdsspanne: 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 force produced by the arm from before the intervention (from baseline) to after its completion as measured by force production recorded with a dynamometer
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Muscle coordination
Tijdsspanne: 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 muscle coordination of the upper extremity muscles as measured using surface electromyography between before the intervention (from baseline) to after its completion.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Joint coordination
Tijdsspanne: 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 coordination of the upper extremity joints as measured motion capture between before the intervention (from baseline) to after its completion.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Corticospinal excitability
Tijdsspanne: 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 corticospinal excitability of the upper extremity muscles as measured using surface electromyography and transcranial magnetic stimulation between before the intervention (from baseline) to after its completion
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Michigan

Onderzoekers

  • Hoofdonderzoeker: Chandramouli Krishnan, PT, PhD, University of Michigan

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 november 2025

Primaire voltooiing (Geschat)

1 oktober 2027

Studie voltooiing (Geschat)

1 oktober 2027

Studieregistratiedata

Eerst ingediend

15 oktober 2025

Eerst ingediend dat voldeed aan de QC-criteria

16 oktober 2025

Eerst geplaatst (Werkelijk)

20 oktober 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

7 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HUM00087962

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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