Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke
5 februari 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
3
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Kaohsiung, Taiwan
- Kaohsiung Chang Gung Memorial Hospital
-
Taipei, Taiwan
- Taipei Chang Gung Memorial Hospital
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Taoyuan, Taiwan
- Taoyuan Chang Gung Memorial Hospital
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change scores of Fugl-Meyer Assessment (FMA)
Tidsram: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
|
|
Change scores of Modified Rankin Scale (mRS)
Tidsram: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change scores of Box and Block Test (BBT)
Tidsram: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
|
|
Change scores of grip and pinch power
Tidsram: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
|
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Change scores of Revised Nottingham Sensory Assessment (RNSA)
Tidsram: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
|
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Change scores of Barthel Index (BI)
Tidsram: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
|
|
Change scores of Activity monitors (ActiGraph)
Tidsram: 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
Tidsram: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
|
|
Change scores of Motor Activities Log (MAL)
Tidsram: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
|
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Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
Tidsram: baseline, 4 weeks, 3 months
|
baseline, 4 weeks, 3 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
World Health Organization Quality of Life (WHOQOL)-BREF
Tidsram: baseline, 4 weeks
|
for caregiver evaluation
|
baseline, 4 weeks
|
|
satisfaction questionnaire
Tidsram: baseline, 4 weeks
|
baseline, 4 weeks
|
|
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patient-reported fatigue and pain ratings
Tidsram: baseline, 4 weeks
|
baseline, 4 weeks
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2016
Primärt slutförande (Faktisk)
1 november 2016
Avslutad studie (Faktisk)
1 november 2016
Studieregistreringsdatum
Först inskickad
29 april 2015
Först inskickad som uppfyllde QC-kriterierna
29 april 2015
Första postat (Uppskatta)
4 maj 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
7 februari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 februari 2017
Senast verifierad
1 november 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 103-7164A3
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