Stroke
Conditions
Keywords
stroke rehabilitation, robot-assisted therapy, hybrid therapy
Brief summary
The aim of the project is to compare the effects of unilateral hybrid therapy \[unilateral robot-assisted therapy (RT)\] + unilateral arm training (UAT)\] and bilateral hybrid therapy \[bilateral RT + bilateral arm training (BAT)\] on motor function, daily function, mobility, life quality, and motor control strategy in stroke patients.
Interventions
PROCEDUREUnilateral Hybrid Intervention
For the unilateral RT training, participants will practice with their affected arms following a unilateral training protocol of BMT for 45 minutes (Yang, et al., 2012). For the UAT training, participants will receive training of the affected UL in functional tasks with behavioral shaping for 45 minutes (Lin, Wu, et al., 2009).
PROCEDUREBilateral Hybrid Intervention
For the bilateral RT training, patients will focus on training involving both arms using the BMT robot for 45 minutes. During the 45 minutes BAT training, participants will receive training in tasks focusing on bilateral symmetric or alternating movements of both ULs.
PROCEDURERobot-Assisted Training
The RT intervention will be matched in duration and intensity with the hybrid interventions. Participants in the RT group will practice on the BMT with bilateral protocols for 90 minutes. The tasks will be tailored according to the level
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
1. ≥3 months onset from a first-ever unilateral stroke; 2. minimal motor criteria to receive CIT (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits); 3. an initial FMA-UE score of 10 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment; 4. no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers); 5. able to follow instructions and perform the study tasks (Mini Mental State Examination ≥ 22); 6. without upper extremity fracture within 3 months; 7. no participation in any rehabilitation experiments or drug studies during the study period; and (8) willing to provide written informed consent.
Exclusion criteria
1. acute inflammatory disease; 2. major health problems or poor physical condition that might limit participation; and (3) attend any other study in recent 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change scores of Fugl-Meyer assessment(FMA) | baseline, 3 weeks, 6 weeks, 18 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change scores of Box and block test (BBT) | baseline, 3 weeks, 6 weeks, 18 weeks |
| Change scores of Action research arm test (ARAT) | baseline, 3 weeks, 6 weeks |
| Change scores of Medical Research Council scale (MRC) | baseline, 3 weeks, 6 weeks |
| Change scores of Modified Ashworth scale (MAS) | baseline, 3 weeks, 6 weeks |
| Change scores of Myoton | baseline, 6 weeks |
| Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI) | baseline, 6 weeks |
| Change scores of Functional independent measure (FIM) | baseline, 3 weeks, 6 weeks |
| Change scores of Stroke Impact Scale (SIS 3.0 version) | baseline, 3 weeks, 6 weeks, 18 weeks |
| Change scores of EuroQol Quality of Life Scale (EQ-5D) | baseline, 6 weeks |
| Change scores of Hand strength | baseline, 3 weeks, 6 weeks |
| Wolf Motor Function Test (WMFT) | baseline, 6 weeks |
| Change scores of ABILHAND Questionnaire | baseline, 6 weeks, 18 weeks |
| Change scores of 10-meter walking test | baseline, 6 weeks |
| Change scores of Nottingham Extended ADL Questionnaire (NEADL) | baseline, 6 weeks, 18 weeks |
| Change scores of Adelaide Activities Profile (AAP) | baseline, 6 weeks |
| Change scores of Accelerometer | baseline, 6 weeks |
| Change scores of kinematic analysis | baseline, 6 weeks |
| Change scores of Adverse effects | baseline, 3 weeks, 6 weeks |
| Change scores of Algometer | baseline, 6 weeks |
| Change scores of Revised Nottingham Sensory Assessment (rNSA) | baseline, 6 weeks |
| Change scores of Motor activity log (MAL) | baseline, 6 weeks, 18 weeks |
Countries
Taiwan
Contacts
Primary ContactChing-Yi Wu, ScD
Outcome results
None listed