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Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke

5. februar 2017 opdateret af: Chang Gung Memorial Hospital

Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke: a Randomized Controlled Trial

The specific aims of this study will be:

  1. To compare the immediate and retention treatment effects of the patients receiving home-based mirror therapy combined with task-oriented training (MTOT) with a hospital-based MTOT group and a hospital conventional rehabilitation group on different aspects of outcomes.
  2. To examine the feasibility, satisfaction, and safety of this novel home-based MTOT program.
  3. To investigate the factors that may affect the efficacy of home-based stroke rehabilitation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In this 3-year study project, we will design a single-blind randomized controlled trial (1) to compare the treatment effects of home-based MTOT with a hospital-based MTOT group and a hospital conventional rehabilitation group, (2) to investigate the feasibility, satisfaction, and safety of this home-based program, and (3) to identify the factors that might influence treatment outcomes. An estimated total of 90 patients with stroke will be recruited in this study. All participants will be randomly assigned to receive home-based MTOT or hospital-based rehabilitation for a 4-week training period (a total of 12 sessions). Before the first treatment session, a client-centered questionnaire will be administered to each patient for identifying individual needs and goals. Feasibility evaluation and caregiver's wellbeing will be also assessed. Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwan
        • Taipei Chang Gung Memorial Hospital
      • Taoyuan, Taiwan
        • Taoyuan Chang Gung Memorial Hospital

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

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • diagnosed as having a unilateral stroke
  • at least 3 months after stroke onset
  • from 20 to 80 years of age
  • having completed acute rehabilitation care or discharged home
  • a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
  • able to follow the therapy instructions (cognition status will be measured by the Montreal Cognitive Assessment)
  • capable of participating in therapy and assessment sessions.

Exclusion Criteria:

  • neglect
  • global or receptive aphasia
  • major medical problems
  • comorbidities that influenced UE usage or caused severe pain

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: home-based MTOT
Home-based mirror therapy combined with task-oriented training (MTOT)
Adfærdsmæssigt: home-based MTOT
The home-based MTOT group will receive 30 minutes of MT followed by 30 minutes of TOT per session. The intervention will take place in the participant's home environment. During the mirror practices, the patient will seat close to a table which the mirror box will be placed at the mid-sagittal plane. During MT, the participant will be encouraged to actively move their paretic arm and hand concurrently with the mirror reflection of the movement of the nonparetic arm and hand as possible as they can. If necessary, the therapist will assist the participant in moving the paretic hand to synchronize the movement with the nonparetic hand.
Aktiv komparator: hospital-based therapy
hospital-based individualized occupational therapy
Adfærdsmæssigt: hospital-based therapy
The control group will receive a dose-matched, individualized occupational therapy at a hospital. The participants will receive customary rehabilitation programs as usual performed at hospitals for 1 hour per session. The treatment protocol will include: (a) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques, (b) fine motor or dexterity training, (c) arm exercises or gross motor training, (d) muscle strengthening of the affected upper limb, and (e) activities of daily living training or functional task practice.
Eksperimentel: hospital-based MTOT
hospital-based mirror therapy combined with task-oriented training (MTOT)
Adfærdsmæssigt: hospital-based MTOT
The hospital-based MTOT group will also receive 30 minutes of MT followed by 30 minutes of TOT per session at a hospital. The intervention will take place in the occupational therapy clinic. The treatment modalities in the hospital will be selected and provided for this group. Most of the treatment principles and components are the same as aforementioned in the home-based MTOT. However, the major differences between home-based and hospital-based MTOT are the treatment contexts, environments and functional modalities used.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change scores of Fugl-Meyer Assessment (FMA)
Tidsramme: baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Modified Rankin Scale (mRS)
Tidsramme: baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months

Sekundære resultatmål

Resultatmål
Tidsramme
Change scores of Box and Block Test (BBT)
Tidsramme: baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of grip and pinch power
Tidsramme: baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Revised Nottingham Sensory Assessment (RNSA)
Tidsramme: baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Barthel Index (BI)
Tidsramme: baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Activity monitors (ActiGraph)
Tidsramme: baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Stroke Impact Scale (SIS) Version 3.0
Tidsramme: baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Motor Activities Log (MAL)
Tidsramme: baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months
Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
Tidsramme: baseline, 4 weeks, 3 months
baseline, 4 weeks, 3 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
World Health Organization Quality of Life (WHOQOL)-BREF
Tidsramme: baseline, 4 weeks
for caregiver evaluation
baseline, 4 weeks
satisfaction questionnaire
Tidsramme: baseline, 4 weeks
baseline, 4 weeks
patient-reported fatigue and pain ratings
Tidsramme: baseline, 4 weeks
baseline, 4 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Chang Gung Memorial 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

1. marts 2016

Primær færdiggørelse (Faktiske)

1. november 2016

Studieafslutning (Faktiske)

1. november 2016

Datoer for studieregistrering

Først indsendt

29. april 2015

Først indsendt, der opfyldte QC-kriterier

29. april 2015

Først opslået (Skøn)

4. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. februar 2017

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 103-7164A3

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 home-based MTOT

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