Prospective Cohort Study : Evaluation of Prognosis Criteria for Walking Independently Recovery After Stroke.

NCT05572892 | Unknown

• 1 other identifier: 2022-A01679-34
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Based on a 2017 US study that developed an algorithm for predicting independent walking recovery after stroke, we propose a prospective study to assess the validity and applicability of this algorithm in the majority of stroke patients with walking dependence and to confirm its performance. This study will therefore include adult patients, hospitalised in the Neurology Department of Caen University Hospital, and presenting a dependence on walking according to the FAC (Functional Ambulation Categories) scale in the first week after stroke. Treated by M. Pierre-Alexis Rousseau (medical intern for Physical and Rehabilitation Medicine), under the direction of Dr. Alexis Ruet, and in collaboration with the physiotherapists of the Neurology Department (Delphine Lebreton and Daphne Scelles), this study is planned to include patients in the initial phase of the stroke, and to continue to follow up the patients until 6 months after their inclusion. The aim of this work is to evaluate the performance of the TWIST algorithm in predicting walking recovery after stroke according to trunk control (using the Trunk Control Test) and hip extension strength (using the Medical Research Council score), and to analyse other factors that may potentially influence walking recovery (such as visual field amputation, neglect, ataxia, depression, undernutrition).

Conditions

Stroke

Keywords

TWIST Algorithm; stroke; prognosis; walking

Outcome Measures

Primary Outcomes (2)

• Functional Ambulation Categories (FAC)

  Functional Ambulation Categories (FAC) to classify the patient's walking as dependent or non-dependent.

  Change from Baseline (first week after stroke) FAC score at 6 weeks after stroke

• Functional Ambulation Categories (FAC)

  Functional Ambulation Categories (FAC) to classify the patient's walking as dependent or non-dependent.

  Change from Baseline (1 week after stroke) FAC score at 12 weeks after stroke

Secondary Outcomes (14)

• Age

  At first week after stroke

• Gender

  At first week after stroke

• National Institutes of Health Stroke Scale (NIHSS) score

  At first week after stroke

• "Visual field" item of the National Institutes of Health Stroke Scale (NIHSS)score

  At first week after stroke

• "Extinction and neglect" item of the National Institutes of Health Stroke Scale (NIHSS)score

  At first week after stroke

Study Arms (1)

Adult patients hospitalised in the Neurology Department of Caen University Hospital

Measurement of walking dependency according to the FAC scale (in the first week after stroke by physiotherapists, at 6 weeks, 12 weeks and 6 months by telephone).

Other: FAC scale

Interventions

FAC scale OTHER

Measurement of walking dependency according to the FAC scale : * in the first week after stroke (in neurology by physiotherapists), * then at 6 weeks, 12 weeks and 6 months (by telephone). Trunk Control Test score (in the first week after stroke, by physiotherapists). MRC score of hip extension and hip flexion, knee flexion/extension, ankle plantar and dorsal flexion (in the first week after stroke, by physiotherapists). PHQ-9 depression scale (at 6 weeks by phone). Denutrition (weight loss between neurology weight and 6-week weight, BMI +/- albumin). Other intercurrent medical problems (at each telephone interview).

Also known as: TCT (Trunk Control Test) score, MRC (Medical Research Council) score, PHQ-9 (Patient Health Questionnaire-9) depression scale

Adult patients hospitalised in the Neurology Department of Caen University Hospital

Eligibility Criteria

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

Study Population

Adult patients ( ≥ 18 years) hospitalised in the Neurology Department of Caen University Hospital who present stroke with walking dependance (FAC scale score \< 4)

You may qualify if:

• Adult patients ( ≥ 18 years) hospitalised in the Neurology Department of Caen University Hospital
• FAC scale score \< 4 (walking dependent) in the first week after stroke
• Oral and written comprehension of the French language
• Affiliation to a social security scheme

You may not qualify if:

• Patient dependent on walking (FAC \< 4) before stroke
• Short-term (\< 3 months) life-threatening condition
• Communication impairment (severe aphasia, impaired consciousness) and/or cognitive impairment preventing informed consent and/or rehabilitation
• Opposition of the patient
• Patient under legal protection (guardianship or curators)

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University Hospital of Caen Normandie

Caen, Normandy, 14000, France

RECRUITING

Related Publications (2)

• Smith MC, Barber PA, Stinear CM. The TWIST Algorithm Predicts Time to Walking Independently After Stroke. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):955-964. doi: 10.1177/1545968317736820. Epub 2017 Nov 1.

  PMID: 29090654 BACKGROUND

• Williams LS, Brizendine EJ, Plue L, Bakas T, Tu W, Hendrie H, Kroenke K. Performance of the PHQ-9 as a screening tool for depression after stroke. Stroke. 2005 Mar;36(3):635-8. doi: 10.1161/01.STR.0000155688.18207.33. Epub 2005 Jan 27.

  PMID: 15677576 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Thrombin Time; antigens, CD200; Patient Health Questionnaire

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alexis Ruet

  Physical Medicine and Rehabilitation Department in the University Hospital of Caen

  STUDY DIRECTOR

• Pierre Alexis Rousseau

  Physical Medicine and Rehabilitation Department in the University Hospital of Caen

  PRINCIPAL INVESTIGATOR

• Clemence Tomadesso

  Clinical Research Unit of University Hospital of Caen

  STUDY CHAIR

Central Study Contacts

Pierre Alexis Rousseau

CONTACT

06 32 97 87 85; pierrealexisrousseau@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 10, 2022
• Study Start: October 7, 2022
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: October 31, 2022

Record last verified: 2022-09

Locations

FR (1)