NCT03277950

Brief Summary

Individuals with stroke show abnormal movement pattern of upper limb. The movement pattern needs to be corrected. There are several methods to train normal movement. Exercise with technology is an active movement and affects sensory and cognitive systems. It may benefit to individuals with stroke in training.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable stroke

Status
unknown

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

First Submitted

Initial submission to the registry

August 27, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

August 27, 2017

Last Update Submit

September 8, 2017

Conditions

StrokeMovement, Abnormal

Keywords

virtual realityfeedback

Outcome Measures

Primary Outcomes (1)

  • kinematic data

    angle of shoulder, elbow, and forearm

    10 minutes

Secondary Outcomes (2)

  • Upper limb performance

    10 minutes

  • muscle tone

    2 minutes

Study Arms (3)

virtual reality with feedback

EXPERIMENTAL

Participants received training via virtual reality game with feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.

Other: Virtual reality with feedback

virtual reality without feedback

ACTIVE COMPARATOR

Participants received training via virtual reality game without feedback, 60 minutes/day, 3 days/week for 4 weeks, then follow up after 4 weeks.

Other: Virtual reality without feedback

Healthy

OTHER

Participants do not play virtual reality game.

Other: Healthy

Interventions

Virtual reality with feedbackOTHER

Individuals with stroke play game with correction of movement.

virtual reality with feedback
Virtual reality without feedbackOTHER

Individuals with stroke play game without correction of movement.

virtual reality without feedback
HealthyOTHER

Healthy do not play game

Healthy

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with stroke
  • years old
  • First ischemic or hemorrhagic stroke
  • Right hemiparesis
  • Right dominant handedness
  • Within 6 months after stroke
  • Discharge from hospital and stay at home
  • Normal dynamic sitting balance
  • At least 120 degrees of shoulder flexion and 45 degrees of shoulder extension by passive range of motion
  • Active movement at least stage 3 by Chedoke-McMaster Stroke Assessment
  • Muscle tone graded 1-2 by Modified Ashworth Scale in 2 of 3 muscle groups including shoulder adductor, internal rotator or/and elbow flexor groups
  • No cognitive impairment
  • Healthy individuals
  • Have same gender and age within range of ±5 years of individuals with stroke
  • Right handedness
  • +2 more criteria

You may not qualify if:

  • Individual with stroke and healthy
  • Have cyber-sickness
  • Obesity
  • Ataxic movement
  • Loss visual field or visual neglect
  • Loss exteroceptive sensation
  • Impaired or loss proprioceptive sensation
  • Receive the occupation therapy on upper extremity
  • Muscle contracture at the scapula, shoulder and elbow
  • Pain at the scapula, shoulder and elbow
  • History of fracture or surgery at head, shoulder, scapula, and elbow
  • Shoulder subluxation
  • Other neurological disorders
  • Uncontrolled hypertension
  • Myocardial infarction
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeDyskinesias

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMovement DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vimonwan Hiengkaew, PhD

    Mahidol University

    STUDY CHAIR

  • Peemonkong Wattananon, PhD

    Mahidol University

    STUDY DIRECTOR

  • Sirada Lolak, BSc

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vimonwan Hiengkaew, PhD

CONTACT

+6624415450vimonwan.hie@mahidol.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 27, 2017

First Posted

September 11, 2017

Study Start

September 15, 2017

Primary Completion

September 15, 2018

Study Completion

September 15, 2019

Last Updated

September 11, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share