RECRUITINGINTERVENTIONAL

Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke

Effects of Proximal Priority Versus Distal Priority Robotic Priming Technique With Rehabilitation Therapy of Upper-Limb Functions in Patients With Chronic Stroke

About This Trial

This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into proximal priority robotic group or distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after intervention.

Who May Be Eligible (Plain English)

Who May Qualify: - The inclusion criteria are age between 20 and 75 years old, more than 3 months after the onset of a first unilateral ischemic or hemorrhagic stroke, moderate to severe UE motor impairment (i.e., total UE score of the Fugl-Meyer Assessment \[FMA\] score between 18 and 56), no severe spasticity in any joints of the affected arm (modified Ashworth Scale score \<3 in any of the affected shoulder, elbow, wrist, and fingers), able to follow instructions (Mini-Mental State Examination total score \>24), no UE fractures in the past 3 months, and not simultaneously participating in other medication or rehabilitation studies. Who Should NOT Join This Trial: - The exclusion criteria are other neurologic, neuromuscular, or orthopedic disease, such as epilepsy, or severe health or physical conditions that might impede participation in this study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * The inclusion criteria are age between 20 and 75 years old, more than 3 months after the onset of a first unilateral ischemic or hemorrhagic stroke, moderate to severe UE motor impairment (i.e., total UE score of the Fugl-Meyer Assessment \[FMA\] score between 18 and 56), no severe spasticity in any joints of the affected arm (modified Ashworth Scale score \<3 in any of the affected shoulder, elbow, wrist, and fingers), able to follow instructions (Mini-Mental State Examination total score \>24), no UE fractures in the past 3 months, and not simultaneously participating in other medication or rehabilitation studies. Exclusion Criteria: * The exclusion criteria are other neurologic, neuromuscular, or orthopedic disease, such as epilepsy, or severe health or physical conditions that might impede participation in this study.

Treatments Being Tested

DEVICE

Bi-Manu-Track

The PRI and DRI protocol provide robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist). The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).In every session of robotic training, the patient will practice bilateral passive range of motion exercise, in which affected upper extremity is assisted by the unaffected side, and bilateral active range of motion exercise. Robotic training will be followed by impairment-oriented training.

Locations (4)

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Taipei Tzu Chi Hospital

New Taipei City, Taiwan

Fongyuan Hospital

Taichung, Taiwan

Taipei Municipal Wan Fang Hospital

Taipei, Taiwan