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

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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: distal upper rehabilitation robot; Device: proximal upper rehabilitation robot

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 142884
    • Recruiting
    • National Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: distal upper rehabilitation robot; experimental group that applied the distal upper rehabilitation robot	Device: distal upper rehabilitation robot; Intervention with distal upper rehabilitation robot
Other: proximal upper rehabilitation robot; control group that applied the proximal upper rehabilitation robot	Device: proximal upper rehabilitation robot; Intervention with proximal upper rehabilitation robot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wolf motor function test	an activity indicator, has 15 items for testing functional ability	change from baseline at 4 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Motor status score	evaluate the impairment level	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
Box and block test	measures unilateral gross manual dexterity	baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline
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
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
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
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

Collaborators and Investigators

• Sponsor: National Rehabilitation Center, Seoul, Korea

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: stroke; upper limb rehabilitation; proximal upper rehabilitation robot; distal upper rehabilitation robot
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NRC-2019-01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No