Stroke Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |