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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
proximal robot-assisted therapy
distal robot-assisted therapy
individualized intensive therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke rehabilitation, robot-assisted therapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital
  • Lo-Sheng Sanatorium and Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

proximal robot-assisted therapy

distal robot-assisted therapy

individualized intensive therapy

Arm Description

treatment programs will target to shoulder and elbow portions of upper extremity via the InMotion2 robotic system

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.

individualized occupational therapy which is dose-match to robot-assisted therapy, based on task-oriented principle.

Outcomes

Primary Outcome Measures

Change scores of Fugl-Meyer assessment(FMA)

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2014
Last Updated
September 14, 2016
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02254343
Brief Title
Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training
Official Title
Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training on Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke rehabilitation, robot-assisted therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
proximal robot-assisted therapy
Arm Type
Experimental
Arm Description
treatment programs will target to shoulder and elbow portions of upper extremity via the InMotion2 robotic system
Arm Title
distal robot-assisted therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
individualized intensive therapy
Arm Type
Active Comparator
Arm Description
individualized occupational therapy which is dose-match to robot-assisted therapy, based on task-oriented principle.
Intervention Type
Device
Intervention Name(s)
proximal robot-assisted therapy
Intervention Type
Device
Intervention Name(s)
distal robot-assisted therapy
Intervention Type
Behavioral
Intervention Name(s)
individualized intensive therapy
Primary Outcome Measure Information:
Title
Change scores of Fugl-Meyer assessment(FMA)
Time Frame
baseline, 2 weeks, 4 weeks
Secondary Outcome Measure Information:
Title
Change scores of Box and block test (BBT)
Time Frame
baseline, 2 weeks, 4 weeks
Title
Change scores of Action research arm test (ARAT)
Time Frame
baseline, 2 weeks, 4 weeks
Title
Change scores of Medical Research Council scale (MRC)
Time Frame
baseline, 2 weeks, 4 weeks
Title
Change scores of Modified Ashworth scale (MAS)
Time Frame
baseline, 2 weeks, 4 weeks
Title
Change scores of Myoton
Time Frame
baseline, 4 weeks
Title
Change scores of Wolf Motor Function Test (WMFT)
Time Frame
baseline, 2 weeks, 4 weeks
Title
Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)
Time Frame
baseline, 4 weeks
Title
Change scores of Functional independent measure (FIM)
Time Frame
baseline, 2 weeks, 4 weeks
Title
Change scores of Stroke Impact Scale (SIS 3.0 version)
Time Frame
baseline, 2 weeks, 4 weeks
Title
Change scores of EuroQol Quality of Life Scale (EQ-5D)
Time Frame
baseline, 4 weeks
Title
Change scores of Hand strength
Time Frame
baseline, 2 weeks, 4 weeks
Title
Change scores of Motor activity log (MAL)
Time Frame
baseline, 4 weeks
Title
Change scores of ABILHAND Questionnaire
Time Frame
baseline, 4 weeks
Title
Change scores of 10-meter walking test
Time Frame
baseline, 4 weeks
Title
Change scores of Nottingham Extended ADL Questionnaire (NEADL)
Time Frame
baseline, 4 weeks
Title
Change scores of Adelaide Activities Profile (AAP)
Time Frame
baseline, 4 weeks
Title
Change scores of Montreal Cognitive Assessment (MoCA)
Time Frame
baseline, 4 weeks
Title
Change scores of Number stroop test
Time Frame
baseline, 4 weeks
Title
Change scores of Accelerometer
Time Frame
baseline, 4 weeks
Title
Change scores of Revised Nottingham Sensory Assessment (rNSA)
Time Frame
baseline, 4 weeks
Title
Change scores of Algometer
Time Frame
baseline, 4 weeks
Title
Change scores of kinematic analysis
Time Frame
baseline, 4 weeks
Title
Change scores of Adverse effects
Time Frame
baseline, 2 weeks, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Yi Wu, ScD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kwei-Shan, Tao-Yuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Lo-Sheng Sanatorium and Hospital
City
Kwei-shan, Toayuan county
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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

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