An interventional study of NTUH-ii, am upper limb rehabilitation robot arm and Traditional upper limb physical therapy in Stroke and Rehabilitation, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-03-04.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
A robot arm for upper limb rehabilitation is intended to achieve rehabilitation effects through the study of robot control theory and the integration of sensors such as sEMG. The goal is to reduce the workload of rehabilitation therapists.
NTUH-ii is an upper limb rehabilitation robot. The aim of this robot is to reduce the workload of rehabilitation therapists and make the rehabilitation process more effective.
The robot can complete rehabilitation tasks, such as elbow flexion/extension, shoulder flexion/extension, and shoulder horizontal abduction/adduction, etc. By giving the desired trajectory, the robot can lead patients to do the tasks in passive mode or active mode.
However, curative rehabilitation should include the motion intention of patients. This study aimed to investigate the efficacy of rehabilitation effect by combining the sensors (such as sEMG, IMU) to obtain the motion intention of patients and give the assistive movement.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 68 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rehabilitation therapists will determine the training mode based on the subject's movement ability. Passive training mode Active-assistive training mode
Device: NTUH-ii, am upper limb rehabilitation robot arm
Traditional upper limb physical therapy is performed by the therapist.
Other: Traditional upper limb physical therapy
Rehabilitation programs are planned based on the subject's capabilities, and the differences between assisted rehabilitation with a robot and traditional rehabilitation are compared.
Traditional upper limb physical therapy is performed by the therapist.
Fugl-Meyer Assessment
Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.
Time frame: 1 month
Fugl-Meyer Assessment
Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome.
Time frame: Before the task and right away the experiment, 3 months, 6 months post intervention.
sEMG analyzation
using sEMG sensors to obtain the sEMG signal and applying 3×2 ANOVA to analyze.
Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Modified Ashworth Scale
To measure the increase of muscle tone, score from 0 to 4, higher scores indicate the higher muscle tone.
Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Wolf Motor Function Test
To quantify upper extremity movement ability through timed single- or multiple-joint motions .and functional tasks.
Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Stroke Impact Scale
A self-report questionnaire that evaluates disability and health-related quality of life after stroke. Score from 0 to 100, Higher scores indicate a better outcome.
Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Motor evoked potential
action potential elicited by noninvasive stimulation of the motor cortex
Time frame: Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention.
Plan to share: No
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