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StrokeFIPBMSNCT04159792

Factors Influencing Postural Balance and Movement in Individuals With Stroke

An observational study of Stroke and Movement, Abnormal, run by Vimonwan Hiengkaew at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Movement, Abnormal, Postural, Balance
How many people
103 participants
Where
1 siteThailand
Study dates
10 Nov 2019to 9 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals with stroke.

Who may be able to join

  • 18 years old and over
  • First stroke

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Siriraj Hospital

    Bangkok, 10700

    Vimonwan Hiengkaew, PhD, +6624415450 ext. 20801, vimonwan.hie@mahidol.ac.th

    Vimonwan Hiengkaew, PhD

Other trials in Thailand

About this study

Official title: Factors Influencing on Postural Balance and Voluntary Movement in Individuals With Acute Stroke

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.

Read the detailed description

Background

Postural control is an important component of movement. Prior to movement initiation, it is necessary to control posture such as gait initiation. Individuals with stroke often show impairment in both postural control and voluntary movement. The deficiencies restrict individuals with stroke to perform activities daily living and reduce quality of life leading to a great burden on family members and healthcare system. Additionally, there are positive association between postural control and movement. Therefore, postural control influences movement in individuals with stroke that may be in long term.

Factors influencing on postural control and voluntary movement are shown in subacute and chronic phase of stroke. Previous stroke, age, bowel incontinence, visuospatial problem, initial severe hemiplegia, lesion edema, and intraparenchymal bleeding can predict postural control. Static and dynamic postural balance can predict functional outcome and discharge destination, as well as independent ambulation in individuals with stroke. Level of paresis, motor-evoked potentials, and size of lesion can predict voluntary movement. Furthermore, baseline upper extremity (UE) voluntary movement, hemorrhagic stroke, baseline National Institutes of Health Stroke Scale (NIHSS), and cortical lesion excluding primary motor cortex can predict outcome of UE movement in subacute stroke. Admission lower extremity (LE) voluntary movement score and volume and edema of lesion are predictors for motor recovery of LE at discharge from rehabilitation ward. Age, severity of LE weakness, visual problems, size of lesion, and type of stroke are predictors for walking ability within 30 days after stroke.

Those factors associating with postural control and voluntary movement were studied in subacute and chronic phase of stroke, but not in the acute period. The findings may limit to apply to the earlier period of stroke since different mechanisms of recovery occurring in different timing after brain injury. Additionally, in clinical practice, one of the common questions that clinicians are often asked by individuals with stroke and family members is whether he/she can sit, stand, and walk. To provide an assurance response, the factors associated with postural control and voluntary movement in the acute phase of stroke is required.

Furthermore, previous studies investigating predictors of postural control and voluntary movement used diverse outcome measures. Posture control were examined by different measures, for example Barthel Index, Mini-Mental State Examination, Frenchay Activity Index and Rankin Scale. Similarly, motor function recovery was assessed by various outcomes such as Scandinavian Stroke Scale, Medical Research Council scale, Motricity index, and exclusive of own scale. These measurements indirectly assessed postural control and voluntary movement. However, there is a measure directly examining postural control and voluntary movement for individuals with stroke that is Postural Assessment Scale for Stroke (PASS) and Stroke Rehabilitation Assessment of Movement (STREAM). These two measurements have excellent reliability and show no floor or ceiling effect in acute stroke. In addition, the PASS is an outcome measure recommended for acute stroke care. It would be, therefore, better using PASS and STREAM to record and for communication.

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.

Methods

The study is observation clinical research. Participants are individuals with stroke admitted to acute stroke unit, Siriraj hospital. They are included if they are first stroke and aged 18 years and over. They are excluded if they recurrent stroke, have 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, heart failure recorded in patient's file, joint limitation in functional range, and difficulty in communication (i.e. sensory aphasia, severe hearing loss). The sample size is calculated with 15% dropout and requires 103 participants.

A researcher will contact physical therapist who is on duty to ask for patients who are in the inclusion criteria. Then, a researcher contacts patients or family members taking responsibility for patients via face to face to inform the study and ask he/she to sign written inform consent if he/she would like to participate in the study. Within 3 days of admission, a researcher will extract the information from patients' file. The information is age, gender, body mass index, Glasgow coma score, onset to admission interval (OAI), hemisphere lesion, affected side, initial National Institute Health Stroke Scale (NIHSS-IN), history of receiving recombinant tissue plasminogen activator (rtPA), thrombectomy, craniotomy, craniectomy, receiving transcranial direct current stimulation (tDCS), days staying in acute stroke unit (DOS), days from admission to first physical therapy (DA-PT), days receiving physical therapy (DPT), days from baseline to final assessment (D-B-FA). Furthermore, progressive stroke and physical therapy treatments are noted. Additionally, the researcher will assess postural control by PASS and voluntary movement by STREAM that will be baseline PASS (PASS-B) and baseline STREAM (STREAM-B). The researcher will take NIHSS score of that day from patient's file (NIHSS-B). The PASS-B includes baseline score of ability to maintain posture (PASS-B_M) and baseline score of ability to control balance changing position (PASS-B_C). The STREAM-B consists of score of upper extremity movement (STREAM-B_UE), baseline score of lower extremity movement (STREAM-B_LE), and baseline score of basic mobility (STREAM-B_Mo).

Before 2 days of discharge or on the day of discharge from the ward the same researcher will assess postural control and voluntary movement again. Hence, the data will be PASS at discharge (PASS-DC) and its subitems (PASS-DC_M; PASS-DC_C), STREAM at discharge (STREAM-DC) and its subitems (STREAM-DC_UE; STREAM-DC_LE; STREAM-DC_Mo).

After discharge at 1st, 3rd, and 6th month participants will assess postural control (PASS-1, PASS-3, PASS-6) and its subitems (PASS-1_M, PASS-1_C, PASS-3_M; PASS-3_C, PASS-6_M; PASS-6_C) voluntary movement (STREAM-1, STREAM-3, STREAM-6) and its subitems (STREAM-1_UE; STREAM-1_LE; STREAM-1_Mo, STREAM-3_UE; STREAM-3_LE; STREAM-3_Mo, STREAM-6_UE; STREAM-6_LE; STREAM-6_Mo). Participants will be contacted via phone to make an appointment for the assessment at Siriraj hospital or home depending on convenience of participants.

Descriptive analysis is performed for subject characteristics with frequency or mean and SD, as appropriate. Association between any of continuous or categorical variables and NIHSS-DC, PASS-DC, STREAM-DC, PASS-1, STREAM-1, PASS-3, STREAM-3, PASS-6, or STREAM-6 is conducted by Pearson correlation or Spearman correlation test, as appropriate. To identify the potential factors for postural control and voluntary movement, univariate analysis is conducted for all variables, then followed by the regression analysis. If the association shows significance with p-value < 0.05, the candidate variable can be assumed as potential factor. Finally, a multiple linear regression analysis was performed to determine the last predictors for PASS and STREAM at discharge. Multicollinearity among independent factors is tested by variance inflation factor (VIF) and admitted if VIF > 10.

Being tested
no intervention
Keywords
stroke, upper limb, lower limb, mobility, posture
Medical subject headings
Stroke, Dyskinesias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

    No intervention

Study groups in NCT04159792
Study groupRoleWhat they receive
strokeThose with standard treatment as usual.
Receives: Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. National Institutes of Health Stroke Scale

    severity of stroke

    Measured: 6 months

  2. Postural Assessment Scale for Stroke

    postural balance

    Measured: 6 months

  3. Stroke Rehabilitation Assessment of Movement

    voluntary movement

    Measured: 6 months

Secondary outcomes (2)
  1. subitem of Postural Assessment Scale for Stroke

    maintain and change posture

    Measured: 6 months

  2. subitem of Stroke Rehabilitation Assessment of Movement

    upper and lower limb movement and basic mobility

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2019
  2. Study start10 Nov 2019 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion9 Nov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
103 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04159792
Sponsor's protocol ID
2019/199.3007
Acronym
FIPBMS
Status last verified
Nov 2019
First submitted
6 Nov 2019
Last updated
12 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 29615859
  • 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.

    PubMed 15468016
  • 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.

    PubMed 24281223
  • 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.

    PubMed 28038342
  • 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.

    PubMed 21745343
  • 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.

    PubMed 26667386
  • 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.

    PubMed 9920188
  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Movement, Abnormal, run by Vimonwan Hiengkaew at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

National Institutes of Health Stroke Scale (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04159792, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.

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