- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04906681
Implementation of a Rehabilitation Technology in Orthopedic and Neurological Rehabilitation to Increase Therapy Dosage: an Exploratory Study
27. maj 2021 opdateret af: Els Knippenberg, PXL University College
Rehabilitation technology is more and more implemented in conventional therapy to increase the dosage of therapy and/or increase patient's motivation towards therapy.
In orthopedic as well as neurological rehabilitation it is important to exercise with enough intensity and repetitions to improve functional performance in activities of daily life, and consequently quality of life.
At the moment, not all (rehabilitation) technologies are adapted towards the wishes and needs of both patients and therapists for everyday use in the clinical setting.
Also, not all technologies are fit for independent use by the patients.
Researcher of PXL have developed a Kinect-based system (i.e.
i-ACT) for rehabilitation and performed supervised research with i-ACT in neurological and musculoskeletal rehabilitation, and older adults.
Within this research, patients will exercise with i-ACT under supervision of their therapist during weekdays, but in the weekends they will be motivated by the medical staff to perform their exercises with i-ACT.
The medical staff will be present for safety reasons, but the patient is asked to use and exercise with i-ACT as independent as possible.
The aim of this research is to explore to which extend i-ACT is suitable for semi-independent use by patients in orthopedic or neurological rehabilitation.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
40
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Els Knippenberg, MSc
- Telefonnummer: +3211775225
- E-mail: els.knippenberg@pxl.be
Undersøgelse Kontakt Backup
- Navn: Fitore Bajrami, BSc
- Telefonnummer: 011 69 91 11
- E-mail: fitore.bajrami@stzh.be
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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- age over 18 years old
- post-operation of arthroplasty (hip or knee), or official medical diagnosis of stroke or Parkinson's disease
- understand Dutch instructions
- patient at St-Trudo ziekenhuis
- experiencing problems in functional performance
Exclusion Criteria:
- neglect
- spasticity (Brunström Fugl-Meyer < 50)
- cognitive disfunction (Mini Mental State Examination < 24)
- visual impairment (blind, cataract, etc.)
- persons who are not able to exit electric wheelchair
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: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Arthroplasty, hip or knee
Minimum 5x/week (of which minimal 3x/week with therapists and 2x/week during weekend), 30-60 minutes training, for 4 weeks, with i-ACT system.
i-ACT provides individualised exercises based on patients own goalsetting.
|
i-ACT is a Microsoft Kinect-based system that provides individualised exercises based on patients own goalsetting.
|
Eksperimentel: Neurology: stroke or Parkinson disease
Minimum 5x/week (of which minimal 3x/week with therapists and 2x/week during weekend), 30-60 minutes training, for 4 weeks, with i-ACT system.
i-ACT provides individualised exercises based on patients own goalsetting.
|
i-ACT is a Microsoft Kinect-based system that provides individualised exercises based on patients own goalsetting.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Canadian Occupational Performance Measure
Tidsramme: Baseline
|
The Canadian Occupational Performance Measure (COPM) is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Scores range from 0 to 10 (best score) in each defined goal.
|
Baseline
|
Canadian Occupational Performance Measure
Tidsramme: 4 weeks
|
The Canadian Occupational Performance Measure (COPM) is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Scores range from 0 to 10 (best score) in each defined goal.
|
4 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
System Usability Scale
Tidsramme: 4 uger
|
Brugbarhed af et system, i denne i-ACT.
Interval af score fra 0 (negativ) til 100 (positiv).
|
4 uger
|
Wolf Motor funktionstest
Tidsramme: Baseline
|
Arm-hånd funktion.
Testen indeholder 17 punkter og scores fra 0 (ikke i stand til at udføre prøve) til 5 (normal præstation).
|
Baseline
|
Wolf Motor funktionstest
Tidsramme: 4 uger
|
Arm-hånd funktion.
Testen indeholder 17 punkter og scores fra 0 (ikke i stand til at udføre prøve) til 5 (normal præstation).
|
4 uger
|
Intrinsic Motivation Inventory
Tidsramme: 1 week
|
The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement questionnaire intended to assess participants' subjective experience with, in this, i-ACT.
The IMI consists of 6 subscales in which a person scores on a scale from 1 (totally not true) to 7 (totally true).
Some scores need to be reversed by subtracting the response score from 8. A total IMI-score is not recommended, therefore subscale scores are used in the analyses.
A higher score means a higher level of the aspect of the subscale.
|
1 week
|
Intrinsic Motivation Inventory
Tidsramme: 4 weeks
|
The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement questionnaire intended to assess participants' subjective experience with, in this, i-ACT.
The IMI consists of 6 subscales in which a person scores on a scale from 1 (totally not true) to 7 (totally true).
Some scores need to be reversed by subtracting the response score from 8. A total IMI-score is not recommended, therefore subscale scores are used in the analyses.
A higher score means a higher level of the aspect of the subscale.
|
4 weeks
|
System Usability Scale
Tidsramme: 1 week
|
Usability of a system, in this i-ACT.
Range of scores from 0 (negative) to 100 (positive).
|
1 week
|
Timed Up and Go test
Tidsramme: Baseline
|
The time between a person standing up from a chair, walking 3 meters before turning around and walking back to sit back in the chair.
|
Baseline
|
Timed Up and Go test
Tidsramme: 4 weeks
|
The time between a person standing up from a chair, walking 3 meters before turning around and walking back to sit back in the chair.
|
4 weeks
|
2 Minute Walking Test
Tidsramme: Baseline
|
This is a measure of the distance a person can walk in 2 minutes.
|
Baseline
|
2 Minute Walking Test
Tidsramme: 4 weeks
|
This is a measure of the distance a person can walk in 2 minutes.
|
4 weeks
|
Barthel Index
Tidsramme: Baseline
|
The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL.
Scores range from 0 to 100.
|
Baseline
|
Barthel Index
Tidsramme: 4 weeks
|
The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL.
Scores range from 0 to 100.
|
4 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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. september 2021
Primær færdiggørelse (Forventet)
1. juni 2022
Studieafslutning (Forventet)
1. juli 2022
Datoer for studieregistrering
Først indsendt
26. maj 2021
Først indsendt, der opfyldte QC-kriterier
26. maj 2021
Først opslået (Faktiske)
28. maj 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. maj 2021
Sidst verificeret
1. maj 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Exploration in St-Trudo
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
All collected IPD that underlie results in a possible publication will be shared.
IPD-delingstidsramme
Starting 3 months after publication.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
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 i-ACT
-
Idorsia Pharmaceuticals Ltd.Afsluttet
-
Karolinska InstitutetRegion Stockholm; Forte; Stiftelsen Frimurarna BarnhusetAktiv, ikke rekrutterendeDepression | Stress, psykologisk | Intellektuel handicap | Angst | Neuroudviklingsforstyrrelser | Traumatisk hjerneskade | Autismespektrumforstyrrelse | Forældre | Attention Deficit Hyperactivity Disorder | Fysisk handicapSverige
-
University of CoimbraFundação para a Ciência e a TecnologiaUkendt
-
Azusa Pacific UniversityTrukket tilbageAngstlidelser | Stresslidelser, traumatiske | AngstForenede Stater
-
Idorsia Pharmaceuticals Ltd.AfsluttetStabil koronararteriesygdomDanmark, Holland, Singapore, Canada, Det Forenede Kongerige, Forenede Stater, Tyskland, Sverige
-
University of NottinghamUkendtCarer Stress SyndromeDet Forenede Kongerige
-
Idorsia Pharmaceuticals Ltd.Afsluttet
-
Idorsia Pharmaceuticals Ltd.AfsluttetFarmakokinetik | Farmakodynamik | Tolerabilitet | SikkerhedHolland
-
Region SkaneTrukket tilbage