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Completed

NCT Number: NCT02254343

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Kwei-Shan, Tao-Yuan, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

proximal robot-assisted therapy

Device

distal robot-assisted therapy

Device

individualized intensive therapy

Behavioral

Primary outcomes

  1. Change scores of Fugl-Meyer assessment(FMA)

    Time frame: baseline, 2 weeks, 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 1, 2014
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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