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

September 14, 2016 updated by: Chang Gung Memorial Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kwei-Shan, Tao-Yuan, Taiwan, 333
        • Chang Gung Memorial Hospital
      • Kwei-shan, Toayuan county, Taiwan, 333
        • Lo-Sheng Sanatorium and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: proximal robot-assisted therapy
treatment programs will target to shoulder and elbow portions of upper extremity via the InMotion2 robotic system
Device: proximal robot-assisted therapy
Experimental: distal robot-assisted therapy
the InMotion3 robot system will be used to execute treatment programs focus on wrist movements. It includes three degrees of freedom to allow wrist flexion/extension, abduction/adduction, and pronation/supination.
Device: distal robot-assisted therapy
Active Comparator: individualized intensive therapy
individualized occupational therapy which is dose-match to robot-assisted therapy, based on task-oriented principle.
Behavioral: individualized intensive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change scores of Fugl-Meyer assessment(FMA)
Time Frame: baseline, 2 weeks, 4 weeks
baseline, 2 weeks, 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 14, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103-3564A3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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