Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Enhancing Participation of Chronic Stroke Patients by Constraint Induced Movement Therapy (HOMECIMT) (HOMECIMT)

14. december 2014 opdateret af: Universitätsklinikum Hamburg-Eppendorf

Enhancing Participation of Chronic Stroke Patients in Primary Care by Modified Constraint Induced Movement Therapy (HOMECIMT)

The aim of this study is to evaluate the efficacy of a modified approach of constraint induced movement therapy ("CIMT at home") for chronic stroke patients, compared to conventional physiotherapy and occupational therapy ("therapy as usual) with regard to the ability to participate in everyday activities.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study is a parallel cluster randomized controlled trial with therapy practices as clusters. After written consent from the patients, the therapists are randomly assigned to treat either the intervention or the control group. Blinded external assessors evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are quality of arm and hand use and arm and hand function. Assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes are analyzed with mixed models, which consider the hierarchical structure of the data, adjusted to the baseline measurements and sex. The primary analysis compares the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints are tested at the significance level of 5% each in hierarchical order.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

156

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Hamburg, Tyskland, 20246
        • Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf

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 ≥ 18 years
  • Stroke onset > 6 months prior to study enrollment
  • upper extremity hemiparesis with impairment of hand and/or arm
  • minimal function of the hand (at least 10º active wrist extension, at least 10º active of thumb abduction/extension, and at least 10º of extension two additional fingers)
  • non-professional coach (e.g. family member)
  • prescription of physical or occupational therapy

Exclusion Criteria:

  • lack of knowledge of German
  • serious impairment of verbal communication ability (e.g. severe aphasia)
  • inability to consent (e.g. dementia)
  • severe neuro-cognitive deficits (MMSE <23)
  • terminal illness, life-threatening co-morbidity
  • simultaneous participation in another treatment study targeting stroke recovery
  • subjects may not have already received constraint induced movement therapy

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
Eksperimentel: mod. Constraint-Induced Movement Therapy
CIMT at home is applied in the patients' home over the course of four weeks including (i.e. 20 consecutive days) 2 hours of daily training together with an instructed non-professional coach (e.g. family member) applying shaping techniques.
Adfærdsmæssigt: mod. Constraint-Induced Movement Therapy
Therapists of the intervention group are trained in "CIMT at home". During an initial home visit the therapist determines together with the patient an individually tailored home training program focussing on everyday practice and instructs the non-professional coach. For four weeks the patients will perform 2 hours of daily training at home together with an instructed non-professional coach (e.g. family member) applying shaping techniques (i.e. 20 consecutive days). Patients are supposed to wear a resting hand splint for the entire treatment period for 4 to 6 hours daily. During the four weeks the therapist will provide 5 weekly visits at the patients' home to instruct and supervise the training.
Andet: Therapy as usual
Patients in this arm will receive usual care dose-matched to the intervention group (250-300 minutes).
Andet: Therapy as usual
Therapy as usual consists of the therapy, which is usually provided by the occupational or physical therapist. Therapy will be applied at the patients home or at the therapists' practice.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT)
Tidsramme: 4 weeks (post-treatment) relative to baseline performance
"Participation" defined as equal involvement in all aspects of society and daily living for people with disabilities is a composite outcome of the following two measures: The MAL-QOM is a self-administered measure of how well 30 daily activities are performed to assess the change in the quality of arm and hand use and the WMFT-PT, measured as the average time (in seconds) to complete 15 tasks, to evaluate the change in arm and hand function.
4 weeks (post-treatment) relative to baseline performance

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Motor Activity Log - Quality Of Movement (MAL-QOM) and MAL- Amount Of Use (MAL-AOU)
Tidsramme: 3 and 6 months relative to baseline performance
to assess the change in the quality and amount of arm and hand use
3 and 6 months relative to baseline performance
Wolf Motor Function Test - Performance Time (WMFT-PT) and WMFT Functional Ability (WMFT-FA)
Tidsramme: 6 months relative to baseline performance
to assess the change in time and quality of movement
6 months relative to baseline performance
Nine-Hole Peg-Test
Tidsramme: 4 weeks (post-treatment) and 6 months relative to baseline performance
to assess finger dexterity
4 weeks (post-treatment) and 6 months relative to baseline performance
Stroke-Impact-Scale (SIS)
Tidsramme: 4 weeks (post-treatment) and 6 months relative to baseline performance
to assess the impact on health and quality of life. A self-administered 59-item questionnaire, which assesses 8 domains of stroke (Strength, Hand Function, Activities of Daily Living / Instrumental Activities of Daily Living, Mobility, Communication, Emotion, Memory and Thinking, and Participation)
4 weeks (post-treatment) and 6 months relative to baseline performance
Barthel Index(BI)
Tidsramme: 4 weeks (post-treatment) and 6 months relative to baseline performance
to assess functional disability i.e. to which somebody can function independently and has mobility in their activities of daily living (ADL)
4 weeks (post-treatment) and 6 months relative to baseline performance
Instrumental Activities of Daily Living Scale (IADL)
Tidsramme: 4 weeks (post-treatment) and 6 months relative to baseline performance
to asses self-maintaining and instrumental activities of daily living
4 weeks (post-treatment) and 6 months relative to baseline performance

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Samarbejdspartnere

German Federal Ministry of Education and Research

Efterforskere

  • Ledende efterforsker: Anne Barzel, MD, Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. oktober 2011

Primær færdiggørelse (Faktiske)

1. juni 2013

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

26. april 2011

Først indsendt, der opfyldte QC-kriterier

27. april 2011

Først opslået (Skøn)

28. april 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2014

Sidst verificeret

1. december 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BMBF-01-GX-1003

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 mod. Constraint-Induced Movement Therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Jordan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner