Prospective Cohort Study : Evaluation of Prognosis Criteria for Walking Independently Recovery After Stroke.
NCT ID: NCT05572892
Last Updated: 2022-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
72 participants
OBSERVATIONAL
2022-10-07
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The interest of the proposed research is to replicate an American landmark study (The TWIST Algorithm Predicts Time to Walking Independently After Stroke, Smith et al.) published in Neurorehabilitation and Neural Repair in 2017, which developed an algorithm to predict recovery of independent walking after stroke, based on clinical assessment of trunk control by the Trunk Control Test (TCT) and Medical Research Council (MRC) motor strength of hip extension.
The performance of the algorithm in predicting return to walking at 6 and 12 weeks was good (\< 6 weeks: Positive Predictive Value = 91%, Negative Predictive Value = 100% // \< 12 weeks: Positive Predictive Value = 100%, Negative Predictive Value = 97%), but requires confirmation given the small number of patients included in the study (N = 41).
The originality of the planned research is to try to include and analyse more patients than the original study, to study other factors that may influence recovery, and to continue the follow-up up to 6 months, which wasn't done in the original study.
The expected results would allow the TWIST algorithm to be confirmed in order to better predict walking recovery independently, which could guide rehabilitation and give patients an estimate of their progress towards walking recovery.
The potential benefits for patients would be to maintain motivation for rehabilitation, and to have an impact on the medico-socio-economic level (notably by avoiding investing resources in unlikely objectives).
There are no foreseeable risks, a priori.
If the results are consistent with those of the original study, it may be possible to consider the application of the TWIST algorithm to routine practice for any first stroke causing walking dependence.
Based on the results of the original study, the patients included will be categorised according to their Truck Control Test (TCT) score and their MRC score for hip extension of the deficient limb :
* TCT score \> 40 = walking before 6 weeks,
* TCT \< 40 + MRC ≥ 3 = walking before 12 weeks,
* TCT \< 40 + MRC \< 3 = dependent on walking after 12 weeks.
For all included patients: PHQ-9 depression scale and body weight at 6 weeks post-stroke, by telephone.
For patients categorised as " walking before 6 weeks " :
* Call and assessment of FAC scale at 6 weeks,
* If walking (FAC ≥ 4), end of follow-up,
* If not, continuation of follow-up with call at 12 weeks.
For patients categorised as " walking before 12 weeks " :
* Call and assessment of FAC scale at 6 and 12 weeks,
* If walking, end of follow-up,
* If not, continue follow-up with call at 6 months.
For patients categorised as " dependent on walking after 12 weeks " :
\- Call and assessment of FAC scale at 6 weeks, 12 weeks and 6 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
FAC scale
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FAC scale
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Caen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexis Ruet
Role: STUDY_DIRECTOR
Physical Medicine and Rehabilitation Department in the University Hospital of Caen
Pierre Alexis Rousseau
Role: PRINCIPAL_INVESTIGATOR
Physical Medicine and Rehabilitation Department in the University Hospital of Caen
Clemence Tomadesso
Role: STUDY_CHAIR
Clinical Research Unit of University Hospital of Caen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of Caen Normandie
Caen, Normandy, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Fabien Chaillot
Role: primary
Clemence Tomadesso
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-A01679-34
Identifier Type: -
Identifier Source: org_study_id