Comparisons of Two Types of Rehabilitation Robot for Upper Extremities

Stroke Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104881
• Other study ID #: NRC-2015-01-005
• Status: Completed
• Phase: N/A
• First received: October 23, 2016
• Last updated: April 10, 2017
• Start date: April 2015
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 3D exoskeleton type robot
3 dimension exoskeleton type upper extremity robot
• 2D end-effector type robot
2 dimension end-effector type upper extremity robot

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Fugl-Meyer Assessment		Fugl-Meyer Assessment change from baseline at 4 weeks
Primary	Wolf motor function test		Fugl-Meyer Assessment change from baseline at 4 weeks
Secondary	Wolf motor function test		baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Secondary	Motor status score		baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Secondary	medical research council scale of upper extremity		baseline
Secondary	Modified Ashworth scale of upeer extremity		baseline
Secondary	Pain of upper extremity	Pain complaints from participants	from baseline to 4 weeks after baseline
Secondary	Stroke impact scale		baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Secondary	Smoothness	Kinematics from Inmotion2 during point-to-point	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Secondary	Reach Error	Kinematics from Inmotion2 during point-to-point	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Secondary	Path Error	Kinematics from Inmotion2 during point-to-point	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Secondary	Mean velocity	Kinematics from Inmotion2 during point-to-point	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Secondary	Maximum velocity	Kinematics from Inmotion2 during point-to-point	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Secondary	Cricle size	Kinematics from Inmotion2 during circle drawing	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Secondary	Cricle independence	Kinematics from Inmotion2 during circle drawing	baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Secondary	Intrinsic motivation inventory		4 weeks after baseline
Secondary	stroke rehabilitation motivation scale		baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline
Secondary	Beck depression index		baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline

External Links

•   Site of the present study