Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke
- Conditions
- Stroke
- Interventions
- Behavioral: home-based MTOTBehavioral: hospital-based therapyBehavioral: hospital-based MTOT
- Registration Number
- NCT02432755
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
- 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.
- neglect
- global or receptive aphasia
- major medical problems
- comorbidities that influenced UE usage or caused severe pain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description home-based MTOT home-based MTOT Home-based mirror therapy combined with task-oriented training (MTOT) hospital-based therapy hospital-based therapy hospital-based individualized occupational therapy hospital-based MTOT hospital-based MTOT hospital-based mirror therapy combined with task-oriented training (MTOT)
- Primary Outcome Measures
Name Time Method Change scores of Fugl-Meyer Assessment (FMA) baseline, 4 weeks, 3 months Change scores of Modified Rankin Scale (mRS) baseline, 4 weeks, 3 months
- Secondary Outcome Measures
Name Time Method Change scores of Barthel Index (BI) baseline, 4 weeks, 3 months Change scores of Box and Block Test (BBT) baseline, 4 weeks, 3 months Change scores of grip and pinch power baseline, 4 weeks, 3 months Change scores of Revised Nottingham Sensory Assessment (RNSA) baseline, 4 weeks, 3 months Change scores of Activity monitors (ActiGraph) baseline, 4 weeks, 3 months Change scores of Stroke Impact Scale (SIS) Version 3.0 baseline, 4 weeks, 3 months Change scores of Motor Activities Log (MAL) baseline, 4 weeks, 3 months Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL) baseline, 4 weeks, 3 months
Trial Locations
- Locations (3)
Taoyuan Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Chang Gung Memorial Hospital
🇨🇳Taipei, Taiwan