Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in People After Stroke (ANANTA)
Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Improve walking ability in people after stroke is a key objective for rehabilitation. Once the rehabilitation period is finished, a reduction of functional and motor abilities is often observed in subjects when they returned home.
This study will examine if loading daily the non paretic leg with additional weights will improve walking abilities. This study will enroll 100 people who had a stroke > three months and < five years and who still experienced difficulties for walking.
Each patient will receive 3 months of intervention targeting their non affected leg. Half of the subjects will have to wear braces with additional weights at the non affected ankle during the day ( > 6 hours), while the other half will wear a similar brace but without weight.
A six minutes walking test will be given before and after the intervention, as well six and twelve months later to measure the effect of these interventions. The investigators hypothesize that people receiving the additional weights to the non paretic leg will show greater improvements in their walk abilities.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Paris, France, 75674
- Sainte Anne Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Hemiparesis following ischemic or hemorrhagic infarct of a single hemisphere
- First episode of stroke experienced > 3 months and < 5 years prior to study enrolment
- Functional Ambulation Categories (FAC) score > 3 < 8
- Be able to walk few meters without physical assistance
- Able to understand and follow instructions
Exclusion Criteria:
- Following inpatient physical rehabilitation
- Experienced more than 2 falls during 3 months prior inclusion
- Signs of bilateral impairments
- Daily use of a wheelchair to move
- Contra-indications for daily walk
- Currently participating in any clinical trial with a experimental walking intervention
- Severe arthrosis
- Dementia
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Weighted brace
|
People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months
|
|
Comparateur placebo: non weighted brace
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People will be given a brace with no weight they will have to wear all the day during three months.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Six minutes walking test
Délai: 3 months after the inclusion
|
Total distance walked in meters (6MWD) within the 6 minutes.
|
3 months after the inclusion
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
six minutes walking test
Délai: 6 months after the inclusion
|
Total distance walked in meters (6MWD) within the 6 minutes
|
6 months after the inclusion
|
|
six minutes walking test
Délai: 12 months after the inclusion
|
Total distance walked in meters (6MWD) within the 6 minutes
|
12 months after the inclusion
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Jean-Philippe Regnaux, PhD, French School of Public Health (EHESP)
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P110702
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