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Clinical Trials/NCT02254343
NCT02254343CompletedNot Applicable

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

Chang Gung Memorial Hospital4 sites in 1 country45 target enrollmentStarted: September 1, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
45
Locations
4
Primary Endpoint
Change scores of Fugl-Meyer assessment(FMA)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Chang Gung Memorial Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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