StrokePROWALKNCT06327035
Evolution of Walking Abilities in Subacute Stroke Patients Hospitalized in Neurorehabilitation Center
An observational study of Stroke and Gait, Hemiplegic, run by Clinique Les Trois Soleils at 3 sites in France.
Trial summary
The goal of this observational study is to describe the evolution of gait recovery during the subacute phase of stroke up to six months after stroke, in patients hospitalized in medical and neurological rehabilitation units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Gait, Hemiplegic
- What is being tested?
- Gait rehabilitation
- How many people
- 400 participants
- Where
- 3 sitesFrance
- Study dates
- 26 Mar 2024to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Stroke patient hospitalized in one of the investigating centers during acute/subacute phase.
Who may be able to join
- Patient hospitalized in one of the investigating centers after acute/subacute stroke.
- Affiliated to a social security scheme
Who cannot join
- Opposed to its participation in this study
- Neurodegenerative disease impacting gait prior to stroke onset
- Patient not walking before stroke
- Progressive pathology with life-threatening consequences within 6 months
- Patient under legal protection
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ophélie Pila, Phd contact
France3 sites, 3 recruiting
- Recruiting
Clinique Les Trois Soleils
Boissise-le-Roi, 77310
Christophe Duret, MD, ch.duret@les-trois-soleils.fr
Christophe Duret, MD
- Recruiting
La Clinique Les Trois Soleils
Boissise-le-Roi, 77310
Ophélie Pila, PhD
Christophe Duret, MD
- Recruiting
Le Normandy
Granville, Normandy, 50400
Anne Peskine, MD, +33233903333, apeskine.normandy@lna-sante.com
Soizic Injeyan, PT, +33233903333, dirmissions.normandy@lna-sante.com
About this study
Official title: Neurological Recovery of the Paretic Lower Limb and Balance and Walking Abilities in the Subacute Phase of Stroke in Patients Hospitalized in Medical and Rehabilitation Units: A Prospective Multicenter Longitudinal Study
The goal of this observational study is to describe the evolution of gait recovery during the subacute phase of stroke up to six months after stroke, in patients hospitalized in medical and neurological rehabilitation units.
- Conditions
- Stroke, Gait, Hemiplegic
- Being tested
- Gait rehabilitation
- Keywords
- stroke, lower limb, gait recovery, balance
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait rehabilitationOther
Assessment of gait and balance abilities after stroke during neurorehabilitation from the subacute phase of stroke to 6 months after stroke.
The assessments will be carried out on entrance to the neurological center, then at 1 ,3 and 6 months and on hospital discharge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulation Classification
The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability.
Measured: Functional Ambulation Classification will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
Secondary outcomes (5)
Postural Assesment Scale for Stroke Patient
The Postural Assessment Scale for Stroke Patients (PASS) assesses balance in lying, sitting and standing positions. It was designed specifically for patients with stroke and is suitable for all individuals regardless of postural performance.
The PASS consists of a 4-point scale where items are scored from 0 - 3. The total score ranges from 0 - 36, the higher the score is, the more favourable the balance in stroke patients.
Measured: Postural Assesment Scale for Stroke Patient will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
Timed Up and Go
The Timed Up and Go is a general physical performance test used to assess mobility, balance and locomotor performance. More specifically, it assesses the ability to perform sequential motor tasks relative to walking and turning.
Measured: Timed Up and Go will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
10-Meter Walk Test
The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance
Measured: 10-Meter Walk Test will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
6Minute-Walk Test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 6Minute-Walk Test will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
Motricity Index
The Motricity Index (MI) is an ordinal method of measuring limb strength. The total score ranges from 0 - 100, with the higher numbers representing good muscle strength.
Measured: Motricity Index will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start26 Mar 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Les Trois Soleils
- Sponsor type
- University, hospital or other
- Collaborators
- Le Normandy
- Responsible party
- Sponsor
- Investigators
- Christophe T Duret, MD, Principal investigator, Les Trois Soleils
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327035
- Sponsor's protocol ID
- 2023-A02660-45
- Acronym
- PROWALK
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2024
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Recovery of the Paretic Lower Limb and Balance and Walking Abilities in the Subacute Phase of Stroke in Patients Hospitalized in Medical and Rehabilitation Units: A Prospective Multicenter Longitudinal Study
- ClinicalTrials.gov ID
- NCT06327035
- Acronym / sponsor ID
- PROWALK / 2023-A02660-45
- Conditions
- Stroke, Gait, Hemiplegic
- Keywords
- stroke, lower limb, gait recovery, balance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Clinique Les Trois SoleilsUniversity, hospital or other
- Collaborators
- Le Normandy
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 25 Mar 2024 (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.
The goal of this observational study is to describe the evolution of gait recovery during the subacute phase of stroke up to six months after stroke, in patients hospitalized in medical and neurological rehabilitation units.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patient hospitalized in one of the investigating centers during acute/subacute phase.
Key inclusion criteria (2 listed)
- Patient hospitalized in one of the investigating centers after acute/subacute stroke.
- Affiliated to a social security scheme
Key exclusion criteria (5 listed)
- Opposed to its participation in this study
- Neurodegenerative disease impacting gait prior to stroke onset
- Patient not walking before stroke
- Progressive pathology with life-threatening consequences within 6 months
- Patient under legal protection
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 |
|---|---|---|
| Gait rehabilitationAssessment of gait and balance abilities after stroke during neurorehabilitation from the subacute phase of stroke to 6 months after stroke. The assessments will be carried out on entrance to the neurological center, then at 1 ,3 and 6 months and on hospital discharge. | Other | – |
Primary outcome
Functional Ambulation Classification
Time frame: Functional Ambulation Classification will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability.
5 secondary outcomes
Postural Assesment Scale for Stroke Patient
Time frame: Postural Assesment Scale for Stroke Patient will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
Timed Up and Go
Time frame: Timed Up and Go will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
10-Meter Walk Test
Time frame: 10-Meter Walk Test will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
6Minute-Walk Test
Time frame: 6Minute-Walk Test will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
Motricity Index
Time frame: Motricity Index will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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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.
Ophélie Pila, Phd contact
Christophe T Duret, MD principal investigator
Les Trois Soleils
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Gait, Hemiplegic, run by Clinique Les Trois Soleils at 3 sites 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 2 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Gaëlle Grosmaire (+33164717372, ag.grosmaire@les-trois-soleils.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Ambulation Classification (time frame: Functional Ambulation Classification will be carried out within 72 hours of admission to the neurological center, then at 1, 3 and 6 months, and at discharge from hospital (assessed up to 5 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.