Stroke
Conditions
Keywords
home-based rehabilitation, stroke, combination therapy, client-centered approach, post-acute
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.
Interventions
BEHAVIORALhome-based 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.
BEHAVIORALhospital-based 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.
BEHAVIORALhospital-based 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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Change scores of Activity monitors (ActiGraph) | 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 Nottingham Extended Activities of Daily Living Scale (NEADL) | baseline, 4 weeks, 3 months |
| Change scores of Revised Nottingham Sensory Assessment (RNSA) | baseline, 4 weeks, 3 months |
| Change scores of Barthel Index (BI) | baseline, 4 weeks, 3 months |
| Change scores of Motor Activities Log (MAL) | baseline, 4 weeks, 3 months |
| Change scores of Stroke Impact Scale (SIS) Version 3.0 | baseline, 4 weeks, 3 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| patient-reported fatigue and pain ratings | baseline, 4 weeks | — |
| World Health Organization Quality of Life (WHOQOL)-BREF | baseline, 4 weeks | for caregiver evaluation |
| satisfaction questionnaire | baseline, 4 weeks | — |
Countries
Taiwan
Outcome results
None listed