The Effect of Application of Proximal and Distal Upper Rehabilitation Robot With Stroke Patients

Stroke Clinical Trial

Official title:

The Effect of Upper Limb Rehabilitation on the Application of Proximal Upper Rehabilitation Robot and Distal Upper Rehabilitation Robot With Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04054700
• Other study ID #: NRC-2019-01-001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: Joon-Ho Shin, MS
• Phone: 82-2-901-1884
• Email: asfreelyas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of the effect of upper limb rehabilitation on the application of proximal upper rehabilitation robot and distal upper rehabilitation robot with stroke patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Hemiplegic patients secondary to first cerebrovascular accidents

• Onset = 3 months

• 29 = Fugl-Meyer Assessment score

• 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:
• distal upper rehabilitation robot
Intervention with distal upper rehabilitation robot
• proximal upper rehabilitation robot
Intervention with proximal upper rehabilitation 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	Wolf motor function test	an activity indicator, has 15 items for testing functional ability	change from baseline at 4 weeks
Primary	Fugl-Meyer Assessment	indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment	change from baseline at 4 weeks
Secondary	Fugl-Meyer Assessment	indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Motor activity log	Assesses the use of the paretic arm and hand during activities of daily living in hemiparetic stroke patients.	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Action reach arm test	to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Motor status score	evaluate the impairment level	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Box and block test	measures unilateral gross manual dexterity	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Wolf motor function test	an activity indicator, has 15 items for testing functional ability	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Mean velocity of upper extremity during reaching task	Mean velocity of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Curvature of upper extremity during reaching task	Curvature of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Jerk of upper extremity during reaching task	Jerk of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Motor evoked potential over motor cortex of the affected side	Motor evoked potential elicited by noninvasive stimulation (rTMS) of the motor cortex	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Secondary	Stroke impact scale 3.0	Total score and individual domain score of stroke impact scale	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline