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Completed

NCT Number: NCT03104881

Comparisons of Two Types of Rehabilitation Robot for Upper Extremities

Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Rehabilitation Center

Seoul, 142884, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hemiplegic patients secondary to first cerebrovascular accidents
  • Onset ≥ 3 months
  • 8 ≤ Fugl-Meyer Assessment score ≤ 30
  • Shoulder or elbow flexor spasticity modified ashworth scale ≤ 3
  • Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion criteria

  • History of surgery of affected upper limb
  • Fracture of affected upper limb

Treatment and study plan

3D exoskeleton type robot

Device

3 dimension exoskeleton type upper extremity robot

2D end-effector type robot

Device

2 dimension end-effector type upper extremity robot

Primary outcomes

  1. Change of Fugl-Meyer Assessment

    Time frame: Fugl-Meyer Assessment change from baseline at 4 weeks

  2. Wolf motor function test

    Time frame: Fugl-Meyer Assessment change from baseline at 4 weeks

Secondary outcomes

  1. Wolf motor function test

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

  2. Motor status score

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

  3. medical research council scale of upper extremity

    Time frame: baseline

  4. Modified Ashworth scale of upeer extremity

    Time frame: baseline

  5. Pain of upper extremity

    Time frame: from baseline to 4 weeks after baseline

    Pain complaints from participants

  6. Stroke impact scale

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

  7. Smoothness

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

    Kinematics from Inmotion2 during point-to-point

  8. Reach Error

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

    Kinematics from Inmotion2 during point-to-point

  9. Path Error

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

    Kinematics from Inmotion2 during point-to-point

  10. Mean velocity

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

    Kinematics from Inmotion2 during point-to-point

  11. Maximum velocity

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

    Kinematics from Inmotion2 during point-to-point

  12. Cricle size

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

    Kinematics from Inmotion2 during circle drawing

  13. Cricle independence

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

    Kinematics from Inmotion2 during circle drawing

  14. Intrinsic motivation inventory

    Time frame: 4 weeks after baseline

  15. stroke rehabilitation motivation scale

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

  16. Beck depression index

    Time frame: baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

Sponsors and collaborators

Lead sponsor

National Rehabilitation Center, Seoul, Korea

Other Gov

Registry information

Official study title

Comparisons of Two Types of Rehabilitation Robot for Upper Extremities: 3 Dimension Exoskeleton Type Upper Extremity Robot vs. 2 Dimension End-effector Type Robot): Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2017
Registry last updated
Apr 12, 2017

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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