StrokeNCT05572892
Prospective Cohort Study : Evaluation of Prognosis Criteria for Walking Independently Recovery After Stroke.
An observational study of Stroke, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- FAC scale
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Caen Normandie
Caen, Normandy, 14000
Fabien Chaillot, 0231065774 ext. +33, chaillot-f@chu-caen.fr
Clemence Tomadesso, 0231065386 ext. +33, tomadesso-c@chu-caen.fr
About this study
Official title: Prognosis Criteria for Walking Independently Recovery After Stroke : Evaluation of the TWIST Algorithm
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.
Read more
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).
Read the detailed description
The ability to walk independently is the most common goal of rehabilitation after a stroke. Whether a patient can walk independently influences decisions about the type and duration of rehabilitation and the proposed destination at discharge from acute care.
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
- Stroke
- Being tested
- FAC scale
- Keywords
- TWIST Algorithm, stroke, prognosis, walking
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAC scaleOther
Also called TCT (Trunk Control Test) score, MRC (Medical Research Council) score, PHQ-9 (Patient Health Questionnaire-9) depression 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: FAC scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulation Categories (FAC)
Functional Ambulation Categories (FAC) to classify the patient's walking as dependent or non-dependent.
Measured: 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.
Measured: Change from Baseline (1 week after stroke) FAC score at 12 weeks after stroke
Secondary outcomes (14)
Age
Demographic characteristic
Measured: At first week after stroke
Gender
Demographic characteristic
Measured: At first week after stroke
National Institutes of Health Stroke Scale (NIHSS) score
Clinical characteristic
Measured: At first week after stroke
"Visual field" item of the National Institutes of Health Stroke Scale (NIHSS)score
Clinical characteristic
Measured: At first week after stroke
"Extinction and neglect" item of the National Institutes of Health Stroke Scale (NIHSS)score
Clinical characteristic
Measured: At first week after stroke
"Ataxia" item of the National Institutes of Health Stroke Scale (NIHSS)score
Clinical characteristic
Measured: At first week after stroke
Medical Research Council (MRC) score for hip extension
Clinical characteristic
Measured: At first week after stroke
Medical Research Council (MRC)score for hip flexion
Clinical characteristic
Measured: At first week after stroke
Medical Research Council (MRC)score for knee extension
Clinical characteristic
Measured: At first week after stroke
Medical Research Council (MRC)score for knee flexion
Clinical characteristic
Measured: At first week after stroke
Medical Research Council (MRC)score for ankle plantar flexion
Clinical characteristic
Measured: At first week after stroke
Medical Research Council (MRC)score for ankle dorsal flexion
Clinical characteristic
Measured: At first week after stroke
Patient Health Questionnaire (PHQ-9) depression scale
Description of the patient's mental health status at the end of the PHQ-9 depression questionnaire
Measured: At 6 weeks after stroke
Undernutrition
Search for weight loss between the weight in neurology and the weight at 6 weeks, Body Mass Index +/- albumin
Measured: At 6 weeks after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start7 Oct 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Ruet, Study director, Physical Medicine and Rehabilitation Department in the University Hospital of CaenPierre Alexis Rousseau, Principal investigator, Physical Medicine and Rehabilitation Department in the University Hospital of CaenClemence Tomadesso, Study chair, Clinical Research Unit of University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572892
- Sponsor's protocol ID
- 2022-A01679-34
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29090654Williams 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.
PubMed 15677576
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Criteria for Walking Independently Recovery After Stroke : Evaluation of the TWIST Algorithm
- ClinicalTrials.gov ID
- NCT05572892
- Acronym / sponsor ID
- 2022-A01679-34
- Conditions
- Stroke
- Keywords
- TWIST Algorithm, stroke, prognosis, walking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The ability to walk independently is the most common goal of rehabilitation after a stroke. Whether a patient can walk independently influences decisions about the type and duration of rehabilitation and the proposed destination at discharge from acute care.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients hospitalised in the Neurology Department of Caen University Hospital | – | Other: FAC scaleMeasurement 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAC scaleAlso: TCT (Trunk Control Test) score, MRC (Medical Research Council) score, PHQ-9 (Patient Health Questionnaire-9) depression scaleMeasurement 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 | Adult patients hospitalised in the Neurology Department of Caen University Hospital |
Primary outcome
Functional Ambulation Categories (FAC)
Time frame: Change from Baseline (first week after stroke) FAC score at 6 weeks after stroke
Functional Ambulation Categories (FAC) to classify the patient's walking as dependent or non-dependent.
Functional Ambulation Categories (FAC)
Time frame: Change from Baseline (1 week after stroke) FAC score at 12 weeks after stroke
Functional Ambulation Categories (FAC) to classify the patient's walking as dependent or non-dependent.
14 secondary outcomes
Age
Time frame: At first week after stroke
Gender
Time frame: At first week after stroke
National Institutes of Health Stroke Scale (NIHSS) score
Time frame: At first week after stroke
"Visual field" item of the National Institutes of Health Stroke Scale (NIHSS)score
Time frame: At first week after stroke
"Extinction and neglect" item of the National Institutes of Health Stroke Scale (NIHSS)score
Time frame: At first week after stroke
"Ataxia" item of the National Institutes of Health Stroke Scale (NIHSS)score
Time frame: At first week after stroke
Medical Research Council (MRC) score for hip extension
Time frame: At first week after stroke
Medical Research Council (MRC)score for hip flexion
Time frame: At first week after stroke
Medical Research Council (MRC)score for knee extension
Time frame: At first week after stroke
Medical Research Council (MRC)score for knee flexion
Time frame: At first week after stroke
Medical Research Council (MRC)score for ankle plantar flexion
Time frame: At first week after stroke
Medical Research Council (MRC)score for ankle dorsal flexion
Time frame: At first week after stroke
Patient Health Questionnaire (PHQ-9) depression scale
Time frame: At 6 weeks after stroke
Undernutrition
Time frame: At 6 weeks after stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Background: PubMed 29090654Smith 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.
- Background: PubMed 15677576Williams 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Ruet study director
Physical Medicine and Rehabilitation Department in the University Hospital of Caen
Pierre Alexis Rousseau principal investigator
Physical Medicine and Rehabilitation Department in the University Hospital of Caen
Clemence Tomadesso study chair
Clinical Research Unit of University Hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Alexis Rousseau (06 32 97 87 85 ext. +33, pierrealexisrousseau@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Ambulation Categories (FAC) (time frame: Change from Baseline (first week after stroke) FAC score at 6 weeks after stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05572892, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.