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Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254343
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE September 29, 2014
First Posted Date  ICMJE October 1, 2014
Last Update Posted Date September 15, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
Change scores of Fugl-Meyer assessment(FMA) [ Time Frame: baseline, 2 weeks, 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • Change scores of Box and block test (BBT) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Action research arm test (ARAT) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Medical Research Council scale (MRC) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Modified Ashworth scale (MAS) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Myoton [ Time Frame: baseline, 4 weeks ]
  • Change scores of Wolf Motor Function Test (WMFT) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI) [ Time Frame: baseline, 4 weeks ]
  • Change scores of Functional independent measure (FIM) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Stroke Impact Scale (SIS 3.0 version) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of EuroQol Quality of Life Scale (EQ-5D) [ Time Frame: baseline, 4 weeks ]
  • Change scores of Hand strength [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Motor activity log (MAL) [ Time Frame: baseline, 4 weeks ]
  • Change scores of ABILHAND Questionnaire [ Time Frame: baseline, 4 weeks ]
  • Change scores of 10-meter walking test [ Time Frame: baseline, 4 weeks ]
  • Change scores of Nottingham Extended ADL Questionnaire (NEADL) [ Time Frame: baseline, 4 weeks ]
  • Change scores of Adelaide Activities Profile (AAP) [ Time Frame: baseline, 4 weeks ]
  • Change scores of Montreal Cognitive Assessment (MoCA) [ Time Frame: baseline, 4 weeks ]
  • Change scores of Number stroop test [ Time Frame: baseline, 4 weeks ]
  • Change scores of Accelerometer [ Time Frame: baseline, 4 weeks ]
  • Change scores of Revised Nottingham Sensory Assessment (rNSA) [ Time Frame: baseline, 4 weeks ]
  • Change scores of Algometer [ Time Frame: baseline, 4 weeks ]
  • Change scores of kinematic analysis [ Time Frame: baseline, 4 weeks ]
  • Change scores of Adverse effects [ Time Frame: baseline, 2 weeks, 4 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • Change scores of Box and block test (BBT) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Action research arm test (ARAT) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Medical Research Council scale (MRC) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Modified Ashworth scale (MAS) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Myoton [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Wolf Motor Function Test (WMFT) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Functional independent measure (FIM) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Stroke Impact Scale (SIS 3.0 version) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of EuroQol Quality of Life Scale (EQ-5D) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of kinematic analysis [ Time Frame: baseline, 2 weeks, 4 weeks ]
  • Change scores of Adverse effects [ Time Frame: baseline, 2 weeks, 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training
Official Title  ICMJE Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training on Stroke Rehabilitation
Brief Summary The purpose of this study is to compare the training effects of robot-assisted therapy focus on proximal part, distal part, or total segment of upper extremity, respectively.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Device: proximal robot-assisted therapy
  • Device: distal robot-assisted therapy
  • Behavioral: individualized intensive therapy
Study Arms  ICMJE
  • Experimental: proximal robot-assisted therapy
    treatment programs will target to shoulder and elbow portions of upper extremity via the InMotion2 robotic system
    Intervention: Device: proximal robot-assisted therapy
  • Experimental: distal robot-assisted therapy
    the InMotion3 robot system will be used to execute treatment programs focus on wrist movements. It includes three degrees of freedom to allow wrist flexion/extension, abduction/adduction, and pronation/supination.
    Intervention: Device: distal robot-assisted therapy
  • Active Comparator: individualized intensive therapy
    individualized occupational therapy which is dose-match to robot-assisted therapy, based on task-oriented principle.
    Intervention: Behavioral: individualized intensive therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2016)
45
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2014)
92
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • unilateral stroke that verified by CT scan
  • Time since stroke more than 6 months
  • moderate and mild upper limb motor impairment identified from the UE subtest of FMA range from 10 to 50
  • Mini-Mental State Examination (MMSE) more than 24 points is needed to follow commands

Exclusion Criteria:

  • serious visual or visual perception problems
  • orthopedic or other neurological problems occurred in recent 6 months
  • attend any other study in recent 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02254343
Other Study ID Numbers  ICMJE 103-3564A3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ching-Yi Wu, ScD Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP