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

Not Applicable

• Conditions: Stroke

• Registration Number: NCT04054700
• Lead Sponsor: National Rehabilitation Center, Seoul, Korea

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Study Start: 2019-10-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wolf motor function test	change from baseline at 4 weeks	an activity indicator, has 15 items for testing functional ability
Fugl-Meyer Assessment	change from baseline at 4 weeks	indicator of the level of impairment of upper extremity, with higher scores indicating lower impairment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Rehabilitation Center; 🇰🇷 Seoul, Korea, Republic of