- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Beer-Sheva, Israel
- SorokaUMC
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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.
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The exercise group will meet on 24 occasions over a period of 12 weeks (2 times/week), 45 minute training session.
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Vad mäter studien?
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Berg Balance Scale
Tidsram: fall will be monitored a year after the completion of the study.
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fall will be monitored a year after the completion of the study.
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Late life Function and Disability Instrument
Tidsram: fall will be monitored a year after the completion of the study
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fall will be monitored a year after the completion of the study
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Get up and go test - stand up and walk 3 meters turn around and walk back to the chair
Tidsram: fall will be monitored a year after the completion of the study
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fall will be monitored a year after the completion of the study
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Step execution test under single and dual task
Tidsram: fall will be monitored a year after the completion of the study
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fall will be monitored a year after the completion of the study
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Stability tests
Tidsram: fall will be monitored a year after the completion of the study
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fall will be monitored a year after the completion of the study
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Dagan Shvartz, M.D., Ben-gurion University of the Negev, Beer-Sheva, Israel
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- sor425606ctil
- ISRCTN4256
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