- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04940403
BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:
31. august 2022 opdateret af: Paolo Bonato, Spaulding Rehabilitation Hospital
BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors: a Comparison of Unimanual vs. Unimanual and Bimanual Tasks During Robot-assisted Arm Training
The focus of this study is to perform a preliminary assessment of the efficacy of the BurtVision system.
While the Burt robotic-arm assists the patient's upper-limb in their movements, BurtVision will allow the patient to perform unimanual and bimanual activities while leveraging augmented reality games.
The investigators will compare clinical outcomes when the BurtVisions ystem is used for training solely relying on unimanual tasks vs. when it is used for training relying on both unimanual and bimanual tasks.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The proposed study is a single-blinded randomized clinical trial to evaluate the effect of using the BurtVistion on motor gains after robot-assisted upper-limb.
Study participants (stroke survivors) will be recruited at the Spaulding Rehabilitation Hospital - Boston.
Subjects will be randomly assigned to one of the two different groups: unimanual or unimanual + bimanual arm therapy using a block-randomized allocation procedure to ensure important covariates, such as baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores and chronicity, are balanced between groups.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
38
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Catherine Adans-Dester, PhD
- Telefonnummer: 617-952-6321
- E-mail: CADANS-DESTER@PARTNERS.ORG
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female, 18-80 years old;
- Unilateral ischemic or hemorrhagic stroke at least 6 months and no more than 5 years prior to study enrollment;
- Upper extremity hemiparesis as characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA-UE) between 12 and 40;
- Some active pro-supination range of motion;
- Some active metacarpal-phalangeal joint in the hemiparetic hand;
- Intact cognitive function to understand the robotic therapy procedures (MMSE>23 and able to follow 3 step command) during initial evaluation visit;
Exclusion Criteria:
- Undergoing upper-limb rehabilitation therapy during the period of the study.
- Severe spasticity (defined as a Modified Ashworth scale score of 3 or more) that would prevent safe use of the robotic system;
- Visual impairments as assessed by the NIH Stroke Scale Visual Field subscale (only subjects with no visual loss will participate in the study); or hemispatial neglect that would impair the subject's ability to play the interactive games (as assessed with the line bisection test);
- Severe proprioceptive deficits that impair the ability to process haptic or visual feedback, as assessed by physical examination during screening;
- Communication impairments such aphasia that impair the subject's ability of providing feedback (as reported by a physician in his/her medical record);
- Individuals with open wounds or recent fracture (<3 months) in the upper extremity, fragile skin or active infection;
- Upper-extremity orthopedic injuries or severe pain resulting in movement limitations.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Unimanual robot-assisted upper-limb rehabilitation
Participants randomized to this arm of the study will undergo 18 one-hour sessions of robot-assisted upper-limb rehabilitation.
During the sessions, study participants will only train their hemiparetic arm (unimanual tasks only).
|
18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt.
|
Eksperimentel: Bimanual robot-assisted upper-limb rehabilitation
Participants randomized to this arm of the study will undergo 18 one-hour sessions of robot-assisted upper-limb rehabilitation.
During the sessions, study participants will train their hemiparetic arm as well as interacting with the contralateral arm for bimanual tasks (unimanual + bimanual tasks).
|
18 one-hour sessions of combination of unimanual and bimanual upper-limb tasks during robot-assisted training with the BurtVision.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Motor Activity Log- Amount of Use
Tidsramme: Data will be collected at baseline and at 7-8 weeks
|
Self-reported measures of upper extremity activity performance in daily life (amount of use)
|
Data will be collected at baseline and at 7-8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Fugl-Meyer Assessment, Upper-Extremity portion
Tidsramme: Data will be collected at baseline and at 7-8 weeks
|
Assessment of the severity of upper-limb motor impairments
|
Data will be collected at baseline and at 7-8 weeks
|
Wolf Motor Function Test
Tidsramme: Data will be collected at baseline and at 7-8 weeks
|
Assessment of arm functional limitations
|
Data will be collected at baseline and at 7-8 weeks
|
Stroke Impact Scale
Tidsramme: Data will be collected at baseline and at 7-8 weeks
|
Self-reported measure of quality of life after stroke
|
Data will be collected at baseline and at 7-8 weeks
|
Motor Activity Log- Quality of Use
Tidsramme: Data will be collected at baseline and at 7-8 weeks
|
Self-reported measures of upper extremity activity performance in daily life (quality of use)
|
Data will be collected at baseline and at 7-8 weeks
|
Upper-Extremity Accelerometry
Tidsramme: Data will be collected at baseline and at 7-8 weeks
|
Amount of arm use over 72 hours recording with wrist-worn sensors
|
Data will be collected at baseline and at 7-8 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Paolo Bonato, PhD, Harvard Medical School, Spaulding Rehabilitation Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. juni 2023
Primær færdiggørelse (Forventet)
31. december 2025
Studieafslutning (Forventet)
1. juni 2026
Datoer for studieregistrering
Først indsendt
17. juni 2021
Først indsendt, der opfyldte QC-kriterier
24. juni 2021
Først opslået (Faktiske)
25. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. september 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2022
Sidst verificeret
1. august 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2021P001807
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Burt
-
Spaulding Rehabilitation HospitalBarrett TechnologyIkke rekrutterer endnu
-
Sunnyview Rehabilitation HospitalGaylord HospitalRekrutteringSlag | Slagtilfælde, Akut | Cerebral vaskulær ulykke | Cerebral vaskulær ulykke (CVA)/slagtilfældeForenede Stater
-
Spaulding Rehabilitation HospitalAfsluttet