Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke
5 février 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
3
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Kaohsiung, Taïwan
- Kaohsiung Chang Gung Memorial Hospital
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Taipei, Taïwan
- Taipei Chang Gung Memorial Hospital
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Taoyuan, Taïwan
- Taoyuan Chang Gung Memorial Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Change scores of Fugl-Meyer Assessment (FMA)
Délai: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Modified Rankin Scale (mRS)
Délai: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Change scores of Box and Block Test (BBT)
Délai: 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
Délai: 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)
Délai: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Barthel Index (BI)
Délai: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Activity monitors (ActiGraph)
Délai: 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
Délai: 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)
Délai: 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)
Délai: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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World Health Organization Quality of Life (WHOQOL)-BREF
Délai: baseline, 4 weeks
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for caregiver evaluation
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baseline, 4 weeks
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satisfaction questionnaire
Délai: baseline, 4 weeks
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baseline, 4 weeks
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patient-reported fatigue and pain ratings
Délai: baseline, 4 weeks
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baseline, 4 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2016
Achèvement primaire (Réel)
1 novembre 2016
Achèvement de l'étude (Réel)
1 novembre 2016
Dates d'inscription aux études
Première soumission
29 avril 2015
Première soumission répondant aux critères de contrôle qualité
29 avril 2015
Première publication (Estimation)
4 mai 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 février 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 février 2017
Dernière vérification
1 novembre 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 103-7164A3
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