Increasing Insight in Spatial Neglect: Unraveling Its Longitudinal Interaction With Motor Function After Stroke

NCT05060458 | Completed

• 1 other identifier: D0011000
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

Goal: Various studies suggest a negative association between spatial neglect and motor outcomes after stroke (Barrett \& Muzaffar 2014) (Kwakkel 2014). Our goal is to assess:

• The longitudinal interaction of the recovery of spatial neglect with the recovery of motor function and outcomes (such as paresis, sitting balance and standing balance)
• Whether the association is different across the different subtypes of spatial neglect (visuospatial/personal/ADL-related)
• The role of compensation strategies for balance control in patients with spatial neglect To do so, we will perform a longitudinal cohort study in which we will repetitively assess post-stroke patients using a comprehensive assessment approach for both spatial neglect and motor outcomes. With regards to neglect, we will evaluate various aspects of both visuospatial and personal neglect. For motor outcomes, we will combine clinical and instrumented (biomechanical) assessment methods to evaluate post-stroke recovery of leg paresis, (sitting and standing) balance and gait.

Conditions

Stroke; Spatial Neglect; Postural Control

Keywords

Stroke; Postural control; Spatial neglect

Outcome Measures

Primary Outcomes (12)

• Change in Rivermead Mobility Index

  Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.

  Change from <14 days to 3 weeks

• Change in Rivermead Mobility Index

  Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.

  Change from 3 weeks - 5 weeks

• Change in Rivermead Mobility Index

  Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.

  Change from 5 weeks - 8 weeks

• Change in Rivermead Mobility Index

  Change in functional balance and mobility. Score from 0 to 15. Higher score means better performance.

  Change from 8 weeks - 12 weeks

• Change in Broken Hearts Test

  Change in cancellation task for visuospatial neglect

  Change from <14 days to 3 weeks

• Change in Broken Hearts Test

  Change in cancellation task for visuospatial neglect

  Change from 3 weeks to 5 weeks

• Change in Broken Hearts Test

  Change in cancellation task for visuospatial neglect

  Change from 5 weeks to 8 weeks

• Change in Broken Hearts Test

  Change in cancellation task for visuospatial neglect

  Change from 8 weeks to 12 weeks

• Functional Ambulation Categories

  Walking evaluation. Score from 0-5. Higher score means better performance.

  Change from <14 days to 3 weeks

• Functional Ambulation Categories

  Walking evaluation. Score from 0-5. Higher score means better performance.

  Change from 3 weeks to 5 weeks

• Functional Ambulation Categories

  Walking evaluation. Score from 0-5. Higher score means better performance.

  Change from 5 weeks to 8 weeks

• Functional Ambulation Categories

  Walking evaluation. Score from 0-5. Higher score means better performance.

  Change from 8 weeks to 12 weeks

Secondary Outcomes (10)

• Trunk Control Test - item quiet sitting for 30 seconds

  <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

• Berg Balance Scale - item quiet standing for 2 minutes

  <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

• Motricity index - lower limbs

  <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

• Fügl-Meyer Motor Assessment - lower limbs

  <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

• 5m walk test

  <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

First-ever stroke patients (inpatient or outpatient)

You may qualify if:

• First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic, anterior circulation stroke
• Age: 18 - 90 years
• Moderate to severe weakness of the lower limb at baseline (MI \</=75)
• Pre-morbid independence in activities of daily living (mRS \</=2) and gait (FAC \>3)
• Able to communicate and comprehend
• Sufficient motivation to participate
• Provided a written informed consent

You may not qualify if:

• Other neurological condition affecting motor functions of the lower limbs
• Pre-existing musculoskeletal impairment severely affecting the gait pattern
• Medically unstable
• Non-corrected vision disorders

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (3)

Antwerp University Hospital

Edegem, Belgium

Location

RevArte

Edegem, Belgium

Location

GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius

Wilrijk, Belgium

Location

Related Publications (1)

• Embrechts E, Schroder J, Nijboer TCW, van der Waal C, Lafosse C, Truijen S, Saeys W. Does visuospatial neglect contribute to standing balance within the first 12 weeks post-stroke? A prospective longitudinal cohort study. BMC Neurol. 2024 Jan 22;24(1):37. doi: 10.1186/s12883-023-03475-1.

  PMID: 38254026 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 29, 2021
• Study Start: November 1, 2019
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

BE (3)