NCT03042455

Brief Summary

This study was designed to establish the clinical evidence for effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of subacute stroke patients.

  • Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to conventional occupational therapy
  • Subjects : total 99 patients with stroke whose upper limb functions are impaired
  • Intervention : 4 weeks of therapy (5 days per week)
  • Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion analysis
  • Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks of intervention, 4) 4 weeks after end of intervention

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2018

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

January 30, 2017

Last Update Submit

March 14, 2019

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

  • Fugl-Meyer Assessment (FMA)

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.

    1 minute before the first intervention

  • Fugl-Meyer Assessment (FMA)

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.

    2 weeks after the first intervention

  • Fugl-Meyer Assessment (FMA)

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.

    4 weeks after the first intervention

  • Fugl-Meyer Assessment (FMA)

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.

    4 weeks after the final intervention

Secondary Outcomes (12)

  • Wolf motor function test

    1 minute before the first intervention

  • Wolf motor function test

    2 weeks after the first intervention

  • Wolf motor function test

    4 weeks after the first intervention

  • Wolf motor function test

    4 weeks after the final intervention

  • Manual Function test

    1 minute before the first intervention

  • +7 more secondary outcomes

Study Arms (3)

Robot and rTMS

EXPERIMENTAL

Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)

Device: Armeo and rTMS

Robot

EXPERIMENTAL

Robot-Assisted upper arm training group(intervention group2)

Device: Armeo

Conventional

ACTIVE COMPARATOR

Conventional training group(control group)

Other: Control group

Interventions

Armeo and rTMSDEVICE

The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. rTMS is a magnetic method used to stimulate small regions of the brain. The Robot and rTMS group will receive the robot-assisted upper arm training and rTMS for 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.

Also known as: Robot-Assisted upper arm training(Armeo), Repetitive Transcranial Magnetic Stimulation(rTMS)
Robot and rTMS
ArmeoDEVICE

The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. The Robot group will receive the robot-assisted upper arm training for 30 minutes daily 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.

Also known as: Robot-Assisted upper arm training(Armeo)
Robot
Control groupOTHER

The conventional group will receive occupational therapy for 30 minutes daily 5 times per week, for 4 weeks instead of Robot or rTMS. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.

Also known as: conventional training
Conventional

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Upper FMA 7-38
  • Hemiplegic patients within 6months after stroke onset
  • male or female, 20 years older

You may not qualify if:

  • Patients with cognitive impairment who are unable to comply with protocol-required procedure
  • Quadriplegic or double hemiplegic patients
  • Patients with musculoskeletal disease, peripheral nerve disease in upper extremity
  • Patients with lower motor neuron disease
  • Patients who cannot perform rTMS
  • Pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic StimulationControl Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 3, 2017

Study Start

June 18, 2015

Primary Completion

June 26, 2018

Study Completion

June 26, 2018

Last Updated

March 18, 2019

Record last verified: 2019-03

Locations

KR(1)