- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00564343
a Water Training Program to Improve Balance in Chronic Stroke Patients
a Water Training Program to Improve Balance in Chronic Stroke Patients: Cross- Sectional Pre-Post Study Design
The proposed project is a case control study design. Subject's suffer from stroke willing to participate in the study will be shortly interviewed to assess eligibility according to the inclusion-exclusion criteria. Subjects suffer from chronic hemiplegia that upon questioning was judged to meet the following inclusion criteria: (a) able to stand independently 90 seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal instructions. The exclusion criteria will be: (a) Serious visual impairment; (b) Inability to ambulate independently (cane acceptable, walker not). (c) Severely impaired cognitive status (score less then 24 in Mini Mental State Examination). (d) Persons with impaired communication capabilities.
The whole project will be conducted over a period of 3 months. A total of 36 subjects will be assigned to water based exercise program. The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week). The subjects of the exercise group will be recruited from Sha'ar Ha'negev Swimming pool and from patients that get a Physical Therapy treatment Kupat Holim Clalit.
Gait and balance function will be tested in both groups with well established measuring techniques before and after the training period. The measuring techniques 1) Medical background variables. 2) Berg Balance Scale. 3) Late life Function and Disability Instrument. 4) Get up and go test - stand up and walk 3 meters turn around and walk back to the chair. 5) step execution test under single and dual task; 5) stability tests. 6) also fall will be monitored a year after the completion of the study. The water training intervention is performed on different levels where each level reflects different increasing demands on the postural control system. For example, the instructor can increase the difficulty of a certain water-exercise by instructing a participant to use less external support, close the eyes, decrease the support area (stand on one leg or narrow the stance, or on unstable surface). These "tools" allow the instructor to implement step exercises on a group level that are still challenging for each individual even if the skill level in the group varies. The water exercises also include perturbation exercises that trigger specific reflex-like balance responses. On each level the instructor can instantly modify an exercise to be more or less challenging for each participant.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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-
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Beer-Sheva, Israël
- SorokaUMC
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Subjects suffer from chronic hemiplegia (a year or more)
- able to stand independently 90 seconds;
- able to walk 10 meters (with cane if necessary);
- able to understand verbal instructions.
Exclusion Criteria:
- Serious visual impairment;
- Inability to ambulate independently (cane acceptable, walker not).
- Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
- Persons with impaired communication capabilities.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
ChSt, water training, Observation
Subjects suffer from chronic hemiplegia (a year or more post stroke) that upon questioning was judged to meet the following inclusion criteria: (a) able to stand independently 90 seconds; (b) able to walk 10 meters (with cane if necessary); (c) able to understand verbal instructions.
The exclusion criteria will be: (a) Serious visual impairment; (b) Inability to ambulate independently (cane acceptable, walker not).
(c) Severely impaired cognitive status (score less then 24 in Mini Mental State Examination).
(d) Persons with impaired communication capabilities.
|
The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week), 45 minute training session.
|
Que mesure l'étude ?
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Berg Balance Scale
Délai: fall will be monitored a year after the completion of the study.
|
fall will be monitored a year after the completion of the study.
|
|
Late life Function and Disability Instrument
Délai: fall will be monitored a year after the completion of the study
|
fall will be monitored a year after the completion of the study
|
|
Get up and go test - stand up and walk 3 meters turn around and walk back to the chair
Délai: fall will be monitored a year after the completion of the study
|
fall will be monitored a year after the completion of the study
|
|
Step execution test under single and dual task
Délai: fall will be monitored a year after the completion of the study
|
fall will be monitored a year after the completion of the study
|
|
Stability tests
Délai: fall will be monitored a year after the completion of the study
|
fall will be monitored a year after the completion of the study
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Dagan Shvartz, M.D., Ben-gurion University of the Negev, Beer-Sheva, Israel
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 (Estimation)
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
- sor425606ctil
- ISRCTN4256
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