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The specific aims of this study will be:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| home-based MTOT | Experimental | Home-based mirror therapy combined with task-oriented training (MTOT) |
|
| hospital-based therapy | Active Comparator | hospital-based individualized occupational therapy |
|
| hospital-based MTOT | Experimental | hospital-based mirror therapy combined with task-oriented training (MTOT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home-based MTOT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change scores of Fugl-Meyer Assessment (FMA) | baseline, 4 weeks, 3 months | |
| Change scores of Modified Rankin Scale (mRS) | baseline, 4 weeks, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Quality of Life (WHOQOL)-BREF | for caregiver evaluation | baseline, 4 weeks |
| satisfaction questionnaire | baseline, 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan | ||||
| Taipei Chang Gung Memorial Hospital |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| hospital-based therapy | Behavioral | 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. |
|
| hospital-based MTOT | Behavioral | 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. |
|
| baseline, 4 weeks, 3 months |
| Change scores of Barthel Index (BI) | 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 |
| patient-reported fatigue and pain ratings | baseline, 4 weeks |
| Taipei |
| Taiwan |
| Taoyuan Chang Gung Memorial Hospital | Taoyuan | Taiwan |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |