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

NCT ID: NCT02254343

Last Updated: 2016-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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proximal robot-assisted therapy

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

Group Type EXPERIMENTAL

proximal robot-assisted therapy

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

distal robot-assisted therapy

Intervention Type DEVICE

individualized intensive therapy

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

Group Type ACTIVE_COMPARATOR

individualized intensive therapy

Intervention Type BEHAVIORAL

Interventions

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proximal robot-assisted therapy

Intervention Type DEVICE

distal robot-assisted therapy

Intervention Type DEVICE

individualized intensive therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ching-Yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Kwei-Shan, Tao-Yuan, , Taiwan

Site Status

Lo-Sheng Sanatorium and Hospital

Kwei-shan, Toayuan County, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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103-3564A3

Identifier Type: -

Identifier Source: org_study_id

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