NCT04159792

Brief Summary

There are several factors influencing on balance and movement in individuals with stroke, such as previous stroke, age, bowel incontinence, visuospatial problem. However, those factors involving in postural control and voluntary movement were studied in subacute and chronic phase of stroke, but not in the acute period. The aim of the study is to determine factors for postural control and voluntary movement in individuals with acute stroke and then follow at the first, third, and sixth month.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

November 6, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

November 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2022

Completed
Last Updated

November 12, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

November 6, 2019

Last Update Submit

November 8, 2019

Conditions

Keywords

strokeupper limblower limbmobilityposture

Outcome Measures

Primary Outcomes (3)

  • National Institutes of Health Stroke Scale

    severity of stroke

    6 months

  • Postural Assessment Scale for Stroke

    postural balance

    6 months

  • Stroke Rehabilitation Assessment of Movement

    voluntary movement

    6 months

Secondary Outcomes (2)

  • subitem of Postural Assessment Scale for Stroke

    6 months

  • subitem of Stroke Rehabilitation Assessment of Movement

    6 months

Study Arms (1)

stroke

Those with standard treatment as usual.

Other: no intervention

Interventions

No intervention

stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with stroke.

You may qualify if:

  • years old and over
  • First stroke

You may not qualify if:

  • Recurrent stroke
  • Having other neurological diseases such as brain tumor, Parkinson's Disease
  • Systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg
  • Having heart failure recorded in patient's file
  • Having joint limitation in functional range
  • Difficulty in communication (i.e. sensory aphasia, severe hearing loss)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (8)

  • Ivanenko Y, Gurfinkel VS. Human Postural Control. Front Neurosci. 2018 Mar 20;12:171. doi: 10.3389/fnins.2018.00171. eCollection 2018.

    PMID: 29615859BACKGROUND
  • Hass CJ, Gregor RJ, Waddell DE, Oliver A, Smith DW, Fleming RP, Wolf SL. The influence of Tai Chi training on the center of pressure trajectory during gait initiation in older adults. Arch Phys Med Rehabil. 2004 Oct;85(10):1593-8. doi: 10.1016/j.apmr.2004.01.020.

    PMID: 15468016BACKGROUND
  • Skolarus LE, Burke JF, Brown DL, Freedman VA. Understanding stroke survivorship: expanding the concept of poststroke disability. Stroke. 2014 Jan;45(1):224-30. doi: 10.1161/STROKEAHA.113.002874. Epub 2013 Nov 26.

    PMID: 24281223BACKGROUND
  • Rajachandrakumar R, Fraser JE, Schinkel-Ivy A, Inness EL, Biasin L, Brunton K, McIlroy WE, Mansfield A. Atypical anticipatory postural adjustments during gait initiation among individuals with sub-acute stroke. Gait Posture. 2017 Feb;52(1):325-331. doi: 10.1016/j.gaitpost.2016.12.020. Epub 2016 Dec 21.

    PMID: 28038342BACKGROUND
  • Craig LE, Wu O, Bernhardt J, Langhorne P. Predictors of poststroke mobility: systematic review. Int J Stroke. 2011 Aug;6(4):321-7. doi: 10.1111/j.1747-4949.2011.00621.x.

    PMID: 21745343BACKGROUND
  • Huang YC, Wang WT, Liou TH, Liao CD, Lin LF, Huang SW. Postural Assessment Scale for Stroke Patients Scores as a predictor of stroke patient ambulation at discharge from the rehabilitation ward. J Rehabil Med. 2016 Mar;48(3):259-64. doi: 10.2340/16501977-2046.

    PMID: 26667386BACKGROUND
  • Daley K, Mayo N, Wood-Dauphinee S. Reliability of scores on the Stroke Rehabilitation Assessment of Movement (STREAM) measure. Phys Ther. 1999 Jan;79(1):8-19; quiz 20-3.

    PMID: 9920188BACKGROUND
  • Lesser M BJ, Dekerlegand J. Use of the postural assessment scale for stroke patients in determining acute care discharge recommendations. J Acute Care Phys Ther 2017:79-85.

    BACKGROUND

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

    Faculty of Physical Therapy, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 12, 2019

Study Start

November 10, 2019

Primary Completion

December 31, 2020

Study Completion

November 9, 2022

Last Updated

November 12, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations