Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke
5. februar 2017 oppdatert av: 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:
- 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.
- To examine the feasibility, satisfaction, and safety of this novel home-based MTOT program.
- To investigate the factors that may affect the efficacy of home-based stroke rehabilitation.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
3
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Kaohsiung, Taiwan
- Kaohsiung Chang Gung Memorial Hospital
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Taipei, Taiwan
- Taipei Chang Gung Memorial Hospital
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Taoyuan, Taiwan
- Taoyuan Chang Gung Memorial Hospital
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: home-based MTOT
Home-based mirror therapy combined with task-oriented training (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
|
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.
|
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Eksperimentell: hospital-based MTOT
hospital-based mirror therapy combined with task-oriented training (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.
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Hva måler studien?
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
|
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Change scores of Revised Nottingham Sensory Assessment (RNSA)
Tidsramme: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
|
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Change scores of Barthel Index (BI)
Tidsramme: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Activity monitors (ActiGraph)
Tidsramme: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Stroke Impact Scale (SIS) Version 3.0
Tidsramme: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Motor Activities Log (MAL)
Tidsramme: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
Tidsramme: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
World Health Organization Quality of Life (WHOQOL)-BREF
Tidsramme: baseline, 4 weeks
|
for caregiver evaluation
|
baseline, 4 weeks
|
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satisfaction questionnaire
Tidsramme: baseline, 4 weeks
|
baseline, 4 weeks
|
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patient-reported fatigue and pain ratings
Tidsramme: baseline, 4 weeks
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baseline, 4 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2016
Primær fullføring (Faktiske)
1. november 2016
Studiet fullført (Faktiske)
1. november 2016
Datoer for studieregistrering
Først innsendt
29. april 2015
Først innsendt som oppfylte QC-kriteriene
29. april 2015
Først lagt ut (Anslag)
4. mai 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
7. februar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. februar 2017
Sist bekreftet
1. november 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 103-7164A3
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