Stroke Clinical Trial
Official title:
Increasing Insight in Spatial Neglect: Unraveling Its Longitudinal Interaction With Motor Function After Stroke
NCT number | NCT05060458 |
Other study ID # | D0011000 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2019 |
Est. completion date | July 11, 2022 |
Verified date | December 2022 |
Source | Universiteit Antwerpen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | July 11, 2022 |
Est. primary completion date | July 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Antwerp University Hospital | Edegem | |
Belgium | RevArte | Edegem | |
Belgium | GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius | Wilrijk |
Lead Sponsor | Collaborator |
---|---|
Universiteit Antwerpen |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Change in Broken Hearts Test | Change in cancellation task for visuospatial neglect | Change from <14 days to 3 weeks | |
Primary | Change in Broken Hearts Test | Change in cancellation task for visuospatial neglect | Change from 3 weeks to 5 weeks | |
Primary | Change in Broken Hearts Test | Change in cancellation task for visuospatial neglect | Change from 5 weeks to 8 weeks | |
Primary | Change in Broken Hearts Test | Change in cancellation task for visuospatial neglect | Change from 8 weeks to 12 weeks | |
Primary | Functional Ambulation Categories | Walking evaluation. Score from 0-5. Higher score means better performance. | Change from <14 days to 3 weeks | |
Primary | Functional Ambulation Categories | Walking evaluation. Score from 0-5. Higher score means better performance. | Change from 3 weeks to 5 weeks | |
Primary | Functional Ambulation Categories | Walking evaluation. Score from 0-5. Higher score means better performance. | Change from 5 weeks to 8 weeks | |
Primary | Functional Ambulation Categories | Walking evaluation. Score from 0-5. Higher score means better performance. | Change from 8 weeks to 12 weeks | |
Secondary | Trunk Control Test - item quiet sitting for 30 seconds | Sitting, hands on lap, feet of the ground. Score from 0 to 2. Higher score means better performance. | <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke | |
Secondary | Berg Balance Scale - item quiet standing for 2 minutes | Ability to stand unsupported. Score from 0 to 4. Higher score means better performance. | <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke | |
Secondary | Motricity index - lower limbs | Strength of the hip flexors, knee extensors and dorsiflexors (paretic vs non paretic limb) | <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke | |
Secondary | Fügl-Meyer Motor Assessment - lower limbs | Selectivity of the paretic lower limb | <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke | |
Secondary | 5m walk test | Walking speed | <14 days, 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke | |
Secondary | Line Bisection Test | Visuospatial neglect test | 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke | |
Secondary | Visuospatial Search Time Test | Visuospatial neglect test | 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke | |
Secondary | Fluff Test | Personal neglect test | 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke | |
Secondary | Tactile extinction test | Personal neglect test | 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke | |
Secondary | Catherine Bergego Scale | ADL related neglect test | 3 weeks, 5 weeks, 8 weeks, 12 weeks post-stroke |
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