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A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training

NCT ID: NCT02274675

Last Updated: 2015-07-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-12-31

Brief Summary

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A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program.

Detailed Description

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The objective of this study is to clinically assess the effectiveness of CR2-Haptic and determine the feasibility of including robotic therapy into the daily rehabilitation program, and investigate the acceptance from patients and therapists. Total of 7 patients will be recruited in this study, all the patients will receive 1.5 hours of standard therapy together with 0.5 hour of robot therapy every day. The robot therapy will be a 30 mins long session for 3 to 5 days per week over a period of six weeks. The study will include forearm pronation-supination and wrist flexion-extension training.

Conditions

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Stroke

Keywords

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Stroke Robot-assisted therapy Rehabilitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Robot group

Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy

Group Type EXPERIMENTAL

Robot-assisted therapy for wrist and forearm

Intervention Type DEVICE

Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.

Standard rehabilitation therapy

Intervention Type OTHER

Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities

Interventions

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Robot-assisted therapy for wrist and forearm

Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.

Intervention Type DEVICE

Standard rehabilitation therapy

Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities

Intervention Type OTHER

Other Intervention Names

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CR2-Haptic Rehabilitation Robot

Eligibility Criteria

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Inclusion Criteria

* Sub-acute and chronic stroke patients
* Able to rest comfortable in training set-up
* Mini-Mental Status Examination (MMSE) Score (\>21)
* Motor Assessment Scale (Balance sitting \>3)
* Modified Ashworth Scale (Wrist \< 2)

Exclusion Criteria

* Contractures in affected upper extremity which inhibit movements being tested
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Stroke Association of Malaysia (NASAM)

UNKNOWN

Sponsor Role collaborator

Collaborative Research in Engineering, Science and Technology Center (CREST)

UNKNOWN

Sponsor Role collaborator

Ministry of Higher Education (Lab2Market)

UNKNOWN

Sponsor Role collaborator

Universiti Teknologi Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Dr.Yeong Che Fai

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yeong C Fai, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Teknologi Malaysia

Locations

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National Stroke Association of Malaysia (NASAM)

Petaling Jaya, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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UTM-CR2-001

Identifier Type: -

Identifier Source: org_study_id