The Therapeutic Effect of the Hand Robot on Stroke Patients Upper-lime Rehabilitation of Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      In the present study, the RMTC finger-hand robot and combined with the mechanism of
      neuroplasticity will be used on the upper-limb rehabilitation of stroke patients. The
      participants will be randomized assigned to treatment group (TG, robot assisted treatment)
      and control group (CG, conventional treatment). In the experimental group, task oriented
      bi-manual training will be applied using the unaffected hand to guide the affected hand by
      RMTC robot system. The investigators will estimate the motor function of distal part of
      upper-limb before and after treatments. The results will be compared with the convention
      rehabilitation treatment. The primary outcomes are Fugl-Meyer assessment (FMA); and the
      secondary outcome measurements are modified Ashworth scale (MAS),Action Reach Arm Test
      (ARAT), Box & block test、Brunnstrom recovery Stage, and motor activity log (MAL).
    

Detailed description: 
      Clinical reports indicated the functional recovery of the distal part of upper limb in stroke
      patient needs time period longer than other body parts, and there is a limitation in the
      efficiency of conventional treatment on the distal part of upper limb. Robot assisted
      rehabilitation is a novel application in treatment. Rehabilitation robot is able to assist
      patients move the affected side through external power to achieve a repeated exercising and
      further evoke the motor function. In the present study, the wearable RMTC finger-hand robot
      and combined with the mechanism of neuroplasticity will be used on the upper-limb
      rehabilitation of stroke patients. The patient (post stroke>1 month) age from 20-90 years old
      with Modified Ashworth Scale ≦2, Brunnstrom Recovery Stage of Arm ≧ 2, Mini-Mental State
      Examination ≧24 will be included as our participation. The participants will be randomized
      assigned to treatment group (TG, robot assisted treatment, n=30) and control group (CG,
      conventional treatment, n=30). In the treatment group, task oriented bi-manual training will
      be applied using the unaffected hand to guide the affected hand by RMTC robot system, the
      patient will also receive additional conventional treatment. In the control group, the
      patient will receive 100 minutes conventional treatment. The investigators will estimate the
      motor function of distal part of upper-limb before and after treatments. The results will be
      compared with the convention rehabilitation treatment. The primary outcomes are Fugl-Meyer
      assessment (FMA); and the secondary outcome measurements are modified Ashworth scale
      (MAS),Action Reach Arm Test (ARAT), Box & block test、Brunnstrom recovery Stage, and motor
      activity log (MAL). The investigators will follow up the patient at the 3rd and 6th month
      after complete trial.
    

Intervention name(s): RMTC finger-hand robot (Mirror Hand); Conventional OT
Intervention type(s): Device; Other
Intervention description(s): The robotic hand will apply on the patient's affected hand and the sensor glove will apply on the patient's un-affected hand, the patient can manipulate their affected hand by their un-affected hand and do the task oriented bimanual training.; The focus of occupational therapy is to help individuals achieve health, well-being, and participation in life through engagement in activities (American Occupational Therapy Association [AOTA], 2014). For stroke rehabilitation, occupational therapy includes retraining in self-care skills, addressing ongoing deficits such as weakness, sensory loss, and cognitive impairments that limit engagement in activities of daily living, and training in community reintegration and modifying tasks or environments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment