Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training on Stroke Rehabilitation

Chang Gung Memorial Hospital2 sites in 1 country45 target enrollmentSeptember 2014

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Chang Gung Memorial Hospital
Enrollment: 45
Locations: 2
Primary Endpoint: Change scores of Fugl-Meyer assessment(FMA)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the training effects of robot-assisted therapy focus on proximal part, distal part, or total segment of upper extremity, respectively.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

September 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chang Gung Memorial Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•unilateral stroke that verified by CT scan
•Time since stroke more than 6 months
•moderate and mild upper limb motor impairment identified from the UE subtest of FMA range from 10 to 50
•Mini-Mental State Examination (MMSE) more than 24 points is needed to follow commands

Exclusion Criteria

•serious visual or visual perception problems
•orthopedic or other neurological problems occurred in recent 6 months
•attend any other study in recent 3 months

Outcomes

Primary Outcomes

Change scores of Fugl-Meyer assessment(FMA)

Time Frame: baseline, 2 weeks, 4 weeks

Secondary Outcomes

Change scores of Accelerometer(baseline, 4 weeks)
Change scores of Algometer(baseline, 4 weeks)
Change scores of Adverse effects(baseline, 2 weeks, 4 weeks)
Change scores of 10-meter walking test(baseline, 4 weeks)
Change scores of Montreal Cognitive Assessment (MoCA)(baseline, 4 weeks)
Change scores of Number stroop test(baseline, 4 weeks)
Change scores of kinematic analysis(baseline, 4 weeks)
Change scores of Box and block test (BBT)(baseline, 2 weeks, 4 weeks)
Change scores of Action research arm test (ARAT)(baseline, 2 weeks, 4 weeks)
Change scores of Modified Ashworth scale (MAS)(baseline, 2 weeks, 4 weeks)
Change scores of Medical Research Council scale (MRC)(baseline, 2 weeks, 4 weeks)
Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)(baseline, 4 weeks)
Change scores of Functional independent measure (FIM)(baseline, 2 weeks, 4 weeks)
Change scores of EuroQol Quality of Life Scale (EQ-5D)(baseline, 4 weeks)
Change scores of Hand strength(baseline, 2 weeks, 4 weeks)
Change scores of Nottingham Extended ADL Questionnaire (NEADL)(baseline, 4 weeks)
Change scores of Wolf Motor Function Test (WMFT)(baseline, 2 weeks, 4 weeks)
Change scores of Stroke Impact Scale (SIS 3.0 version)(baseline, 2 weeks, 4 weeks)
Change scores of ABILHAND Questionnaire(baseline, 4 weeks)
Change scores of Motor activity log (MAL)(baseline, 4 weeks)
Change scores of Adelaide Activities Profile (AAP)(baseline, 4 weeks)
Change scores of Myoton(baseline, 4 weeks)
Change scores of Revised Nottingham Sensory Assessment (rNSA)(baseline, 4 weeks)