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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

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.

Condition or disease Intervention/treatment Phase
Stroke Device: proximal robot-assisted therapy Device: distal robot-assisted therapy Behavioral: individualized intensive therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training on Stroke Rehabilitation
Study Start Date : September 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: proximal robot-assisted therapy
treatment programs will target to shoulder and elbow portions of upper extremity via the InMotion2 robotic system
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.
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.
Behavioral: individualized intensive therapy



Primary Outcome Measures :
  1. Change scores of Fugl-Meyer assessment(FMA) [ Time Frame: baseline, 2 weeks, 4 weeks ]

Secondary Outcome Measures :
  1. Change scores of Box and block test (BBT) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  2. Change scores of Action research arm test (ARAT) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  3. Change scores of Medical Research Council scale (MRC) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  4. Change scores of Modified Ashworth scale (MAS) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  5. Change scores of Myoton [ Time Frame: baseline, 4 weeks ]
  6. Change scores of Wolf Motor Function Test (WMFT) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  7. Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI) [ Time Frame: baseline, 4 weeks ]
  8. Change scores of Functional independent measure (FIM) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  9. Change scores of Stroke Impact Scale (SIS 3.0 version) [ Time Frame: baseline, 2 weeks, 4 weeks ]
  10. Change scores of EuroQol Quality of Life Scale (EQ-5D) [ Time Frame: baseline, 4 weeks ]
  11. Change scores of Hand strength [ Time Frame: baseline, 2 weeks, 4 weeks ]
  12. Change scores of Motor activity log (MAL) [ Time Frame: baseline, 4 weeks ]
  13. Change scores of ABILHAND Questionnaire [ Time Frame: baseline, 4 weeks ]
  14. Change scores of 10-meter walking test [ Time Frame: baseline, 4 weeks ]
  15. Change scores of Nottingham Extended ADL Questionnaire (NEADL) [ Time Frame: baseline, 4 weeks ]
  16. Change scores of Adelaide Activities Profile (AAP) [ Time Frame: baseline, 4 weeks ]
  17. Change scores of Montreal Cognitive Assessment (MoCA) [ Time Frame: baseline, 4 weeks ]
  18. Change scores of Number stroop test [ Time Frame: baseline, 4 weeks ]
  19. Change scores of Accelerometer [ Time Frame: baseline, 4 weeks ]
  20. Change scores of Revised Nottingham Sensory Assessment (rNSA) [ Time Frame: baseline, 4 weeks ]
  21. Change scores of Algometer [ Time Frame: baseline, 4 weeks ]
  22. Change scores of kinematic analysis [ Time Frame: baseline, 4 weeks ]
  23. Change scores of Adverse effects [ Time Frame: baseline, 2 weeks, 4 weeks ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254343


Locations
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Taiwan
Chang Gung Memorial Hospital
Kwei-Shan, Tao-Yuan, Taiwan, 333
Lo-Sheng Sanatorium and Hospital
Kwei-shan, Toayuan county, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Ching-Yi Wu, ScD Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02254343    
Other Study ID Numbers: 103-3564A3
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Keywords provided by Chang Gung Memorial Hospital:
stroke rehabilitation
robot-assisted therapy
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases