Trial record 2 of 214105 for:    ALL

Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2016 by China Medical University Hospital
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT02755415
First received: April 21, 2016
Last updated: April 26, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Stroke
Device: HIWIN Robotic Gait Training System
Other: Static Standing Table

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Berg Balance Scale [ Time Frame: 15-20 minutes ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Pittsburgh Sleep Quality Index [ Time Frame: 10-15 minutes ] [ Designated as safety issue: No ]
    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

  • EuroQol five dimensions questionnaire (EQ-5D) [ Time Frame: 10-15 minutes ] [ Designated as safety issue: No ]
    EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status.

  • Resting muscle tone [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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.

  • Resting muscle elasticity [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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.

  • Six minute walk test [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]
    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.

  • Beck's depression Inventory [ Time Frame: 7-10 minutes ] [ Designated as safety issue: No ]
    The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.


Estimated Enrollment: 60
Study Start Date: May 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Static Standing Table Training
Patients in this group will receive standard hospital based rehabilitation as well as static standing table training
Other: Static Standing Table
As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position
Experimental: Robotic Gait Training
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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the age of 20-80 years;
  • Diagnosis of first, single unilateral cortical-subcortical acute stroke verified by brain imaging;
  • Paresis of a lower limb;
  • Ability to walk for only a few meters either with or without aid.

Exclusion Criteria:

  • Deemed by a physician to be medically unstable;
  • Other prior musculoskeletal conditions that affected gait capacity;
  • Co-existence of other neurological diseases;
  • Cognitive impairments that would impact on the safe participation in the study (MMSE<23)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02755415

Locations
Taiwan
China Medical University Hospital Not yet recruiting
Taichung, Taiwan, 408
Contact: Li-Wei Chou, MD, MSc    +886-4-22052121 ext 2381    chouliwe@gmail.com   
Principal Investigator: Li-Wei Chou, MD, PhD, MSc         
Sub-Investigator: Nai-Hsin Meng, MD         
Sub-Investigator: Andy Chien, PhD         
Sponsors and Collaborators
China Medical University Hospital
  More Information

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02755415     History of Changes
Other Study ID Numbers: CMUH105-REC1-037 
Study First Received: April 21, 2016
Last Updated: April 26, 2016
Health Authority: Taiwan: Research Ethics Committee

Keywords provided by China Medical University Hospital:
Rehabilitation
Robotic
Gait
Quality of Life

Additional relevant MeSH terms:
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 27, 2016