Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke
5 februari 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
3
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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-
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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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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: home-based MTOT
Home-based mirror therapy combined with task-oriented training (MTOT)
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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.
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Actieve vergelijker: hospital-based therapy
hospital-based individualized occupational therapy
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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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Experimenteel: hospital-based MTOT
hospital-based mirror therapy combined with task-oriented training (MTOT)
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change scores of Fugl-Meyer Assessment (FMA)
Tijdsspanne: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
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Change scores of Modified Rankin Scale (mRS)
Tijdsspanne: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change scores of Box and Block Test (BBT)
Tijdsspanne: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of grip and pinch power
Tijdsspanne: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Revised Nottingham Sensory Assessment (RNSA)
Tijdsspanne: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Barthel Index (BI)
Tijdsspanne: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Activity monitors (ActiGraph)
Tijdsspanne: 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
Tijdsspanne: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
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Change scores of Motor Activities Log (MAL)
Tijdsspanne: 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)
Tijdsspanne: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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World Health Organization Quality of Life (WHOQOL)-BREF
Tijdsspanne: baseline, 4 weeks
|
for caregiver evaluation
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baseline, 4 weeks
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satisfaction questionnaire
Tijdsspanne: baseline, 4 weeks
|
baseline, 4 weeks
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patient-reported fatigue and pain ratings
Tijdsspanne: baseline, 4 weeks
|
baseline, 4 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2016
Primaire voltooiing (Werkelijk)
1 november 2016
Studie voltooiing (Werkelijk)
1 november 2016
Studieregistratiedata
Eerst ingediend
29 april 2015
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2015
Eerst geplaatst (Schatting)
4 mei 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
7 februari 2017
Laatste update ingediend die voldeed aan QC-criteria
5 februari 2017
Laatst geverifieerd
1 november 2016
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 103-7164A3
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