An interventional study of HIWIN Robotic Gait Training System and Static Standing Table in Stroke, sponsored by China Medical University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-07-27.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment
Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for acute stroke survivors. It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.
Stroke is not only the second leading cause of mortality in Taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society. Array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength. Given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients. However, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients. Moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse. It is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
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Exclusion Criteria:
Patients in this group will receive standard hospital based rehabilitation as well as static standing table training
Other: Static Standing Table
Patients in this group will receive standard hospital based rehabilitation as well as robot-assisted gait rehabilitation training
Device: HIWIN Robotic Gait Training System
HIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training
As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position
Berg Balance Scale
The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities and is generally considered to be the gold standard for clinical practice
Time frame: 15-20 minutes
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders
Time frame: 10-15 minutes
EuroQol five dimensions questionnaire (EQ-5D)
EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status.
Time frame: 10-15 minutes
Resting muscle tone
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle tone (oscillation frequency \[Hz\]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
Time frame: 10 minutes
Resting muscle elasticity
A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle elasticity (Oscillation stiffness \[N/m\]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
Time frame: 10 minutes
Six minute walk test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Time frame: 6 minutes
Beck's depression Inventory
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Time frame: 7-10 minutes
Plan to share: No — Individual participant data will remain confidential and accessible to only the approved researchers
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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China Medical University Hospital