What do Stroke Survivors Actually Learn When Regaining Walking Ability After Stroke? The TARGET Phase I Study

NCT03728036 | Completed

• 2 other identifiers: JS-11S64819N
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 3

Brief Summary

Phase I: Exploring what stroke survivors exactly learn when recovering the ability to stand and walk.

Conditions

Stroke; Paresis; Gait, Hemiplegic

Keywords

walking; recovery; compensation

Outcome Measures

Primary Outcomes (1)

• Functional Ambulation Categories

  This scale indicates the ability to walk independently and serves as the primary outcome measure.

  12 weeks post-stroke]

Secondary Outcomes (8)

• Trunk Control Test - item sitting balance

  Baseline (0-1 week post-stroke)

• Motricity Index - subscale lower limb

  Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

• Fugl Meyer Motor Assessment - subscale lower limb

  Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

• Berg Balance Scale - item standing unsupported

  Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

• Functional Ambulation Categories

  Baseline (0-1 week post-stroke), 3 weeks post-stroke, 5 weeks post-stroke, 8 weeks post-stroke, 12 weeks post-stroke, 24 weeks post-stroke

Interventions

conventional rehabilitation BEHAVIORAL

The investigated cohort will be exposed to 'standard care' including conventional rehabilitation therapy.

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

Patients admitted to the neurology department of the Antwerp University Hospital after acute stroke will be contacted and asked to participate. Information about the study's aim will be provided with a clear understanding of what is expected from the participant. If the patient express willingness to enter the study, the examination on in- and exclusion criteria will be performed. If the patient is considered eligible, an informed consent will be signed.

You may qualify if:

• First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic, anterior circulation stroke
• Age: 18 - 90 years
• Baseline assessments within the first 14 days after stroke onset
• Weakness of the lower limb (NIHSS item \>0 at 72 hours post-stroke)
• 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:

• No other neurological condition affecting motor functions of the lower limbs
• Pre-existing musculoskeletal impairment severely affecting the gait pattern

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator

Study Sites (3)

Antwerp University Hospital

Antwerp, Belgium

Location

RevArte Rehabilitation Hospital

Antwerp, Belgium

Location

GZA Ziekenhuis - campus St Augustinus & Campus St Vincentius

Wilrijk, 2610, Belgium

Location

Related Publications (1)

• Schroder J, Saeys W, Embrechts E, Hallemans A, Yperzeele L, Truijen S, Kwakkel G. Recovery of Quiet Standing Balance and Lower Limb Motor Impairment Early Poststroke: How Are They Related? Neurorehabil Neural Repair. 2023 Aug;37(8):530-544. doi: 10.1177/15459683231186983. Epub 2023 Aug 19.

  PMID: 37596887 DERIVED

MeSH Terms

Conditions

Stroke; Paresis; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonas Schröder, PhD Student

  Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

• Wim Saeys, Prof. Dr.

  Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium

  STUDY DIRECTOR

• Steven Truijen, Prof. Dr.

  Dept. Rehabilitation Sciences & Physiotherapy, University of Antwerp, Belgium

  STUDY CHAIR

• Gert Kwakkel, Prof. Dr.

  Dept. Rehabilitation Medicine, VU University Medical Center, Amsterdam, Netherlands

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, PhD researcher

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 1, 2018
• Study Start: November 1, 2018
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)