The Effect of Early Mobilization in Mild to Moderate Hemorrhagic Stroke

NCT03292211 | Completed

• 1 other identifier: 201706073RINB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the outcomes of early mobilization and early intervention within 24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care unit within 24 hours after stroke. The patients after hemorrhagic stroke who undergo early intervention only will be compared with those who also receive early mobilization in order to determine if the early mobilization intervention results in earlier or more effective recovery of postural stability, activities of daily living function, or motor capacity. The participants will be randomly assigned to the following two groups: (1) the early mobilization (+early rehabilitation) group and (2) the early rehabilitation group.The measurement parameters will be collected before the intervention (basic parameters), two weeks after the stroke, four weeks after the stroke and three months after the stroke. SPSS (version 17.0) will be used to carry out repeated measures analysis of variance (repeated ANOVA) to compare the differences between the groups at different time points (including basic values and follow-up values). For statistical significance, Bonferroni correction will be applied for the post-hoc analysis of the groups.

Conditions

Hemorrhagic Stroke

Keywords

Early mobilization; Acute stroke; Early intervention; Early mobilization therapy

Outcome Measures

Primary Outcomes (1)

• the score-change of the Functional Independence Measure (FIM) assessment for daily living function

  The functional independence of patient's capacities in terms of activity of daily living. The instrument assesses motor domain including dependence in self-care, sphincter management, transfer, locomotion as well as cognition domain including communication, social interaction and cognition.

  baseline, 2-week, 4-week and three months after stroke

Secondary Outcomes (7)

• the number of days required to reach a sitting>5 minutes milestone

  baseline to within 3 months after stroke

• the number of days required to reach a standing>1 minute milestone

  baseline to within 3 months after stroke

• the number of days required to reach a walking>50 meters milestone using the functional ambulation category (FAC)

  baseline to within 3 months after stroke

• the number of serious adverse events

  baseline to within 3 months after stroke

• the score-change of the Postural Assessment Scale for Stroke Patients (PASS)

  baseline, 2-week, 4-week and three months after stroke

Study Arms (2)

early mobilization

EXPERIMENTAL

early mobilization group will commence rehabilitation consisting of out-of-bed mobilization (including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.)

Behavioral: early mobilization

early standard intervention

OTHER

early standard intervention included bed exercises including the joint range of motion exercise, bridge exercise, the straight leg raising exercise, stretching exercises, and the facilitation techniques during the period in a stroke center.

Behavioral: early standard intervention

Interventions

early mobilization BEHAVIORAL

early out-of-bed activities including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.within three days after stroke while being monitored by medical equipment.

early mobilization

early standard intervention BEHAVIORAL

Conventional early in-bed activities within three days after stroke

early standard intervention

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with a first time intracerebral (either cortical or subcortical) hemorrhage with unilateral hemiparesis/ hemiplegia confirmed by magnetic resonance imaging or computed tomography;
• patients with no contraindications to being mobilized (early intervention) within 24 hours of stroke onset (based on the medical team's clinical judgment: including systolic blood pressure (SBP)\<160mmHg in resting; resting heart rate (HR)\<130 bpm; no hydrocephalus; 80\< mean arterial pressure (MAP)\<110 mmHg before intervention);
• patients with National Institutes of Health Stroke Scale (NIHSS) scores at admission ranging from 1 to 20;
• patients with total activity of living independence pre-stroke; and
• patients between 20 and 80 years old.

You may not qualify if:

• patients with mild to moderate deficits as described above (3);
• patients who are unable to complete the baseline survey because of serious aphasia, language difficulties, or cognitive deficits;
• patients with other medical conditions, such as severe heart failure, acute coronary syndrome, or lower-limb disorders, that prevent early mobilization; and
• patients who are unable to provide informed consent. In addition, we will exclude those showing rapid early deterioration of symptoms, as well as those with a concurrent diagnosis of rapidly deteriorating disease (e.g., terminal cancer).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• Yen HC, Jeng JS, Chen WS, Pan GS, Chuang Pt Bs WY, Lee YY, Teng T. Early Mobilization of Mild-Moderate Intracerebral Hemorrhage Patients in a Stroke Center: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2020 Jan;34(1):72-81. doi: 10.1177/1545968319893294. Epub 2019 Dec 20.

  PMID: 31858865 DERIVED

MeSH Terms

Conditions

Hemorrhagic Stroke; Stroke

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Jiann-Shing Jeng

  NTUH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2017
• First Posted: September 25, 2017
• Study Start: September 12, 2017
• Primary Completion: November 9, 2018
• Study Completion: February 10, 2019
• Last Updated: April 12, 2019

Record last verified: 2018-09

Locations

TW (1)