- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01743430
Development of Smart Holistic Telerehabilitation System: An Application of Stroke Patients- 3 Years Study (telerehab)
1. Telerehabilitation on Balance in Subacute Stroke; 2.Telerehabilitation on Balance and Daily Activities in Chronic Stroke; 3. Telerehabilitation on Quality of Life in Chronic Stroke; 4. Telerehabilitation on Satisfaction in Stroke
Study 1: Background and Purpose-This study were to set up the telerehabilitation program for standing balance training, and to examine the training effects on balance and daily activities in subjects with subacute stroke.The null hypothesis included telerehabilitation balance training were not significantly different from conventional balance training in subjects with subacute stroke.
Study 2: The purpose of this study was to investigate the effects of telerehabilitation with group therapy on balance and daily activities in subjects with stroke living in long-term care facilities (LTC).The null hypothesis would be telerehabilitation balance training were not significantly different from conventional balance training in subjects with subacute stroke.
study 3:To investigate whether a four-week tele-rehabilitation program can result in significant improvements in physical function and quality of life for subjects with chronic stroke living in long-term care facilities.
Study 4: To compare the effects of a home-based telerehabilitation (Tele) with intelligent agent systems and a conventional in-home physical therapy (home PT) for subjects with stroke.
Przegląd badań
Szczegółowy opis
Study 1: Methods-Twenty-four subjects with substroke (less than 6 months post-stroke) were recruited for telerehabilitation group and conventional balance training group. Study 2. Methods-Twenty -four participants with mild to moderate stroke were randomized into telerehabilitation (Tele) group and conventional (Conv) group. They received balance training with three sessions per week for 4 weeks. The pressure distribution of buttock-pressure interface was measured by Pressure Distribution Plate (PDM-S).
Study 3.Methods: Twenty-four participants were recruited from three long-term care facilities. Participants were assigned into tele-rehabilitation (Tele group) and conventional Groups (Con group) randomly. Baseline and post-treatment physical function, daily activities and health-related quality of life (HRQOL) were assessed by Simplified-STREAM, Berge Balance scale (BBS), Barthel index (BI), and Stroke Impact Scale (SIS 3.0), respectively. Interventions were conducted to both groups by two different physical therapists with three sessions a week for four weeks of intervention.
Study 4. Ten participants with stroke were randomized into Tele or control group 1 (CG1) for randomized controlled trial. The Tele group also received home PT at 3 weeks later as control group 2 (CG2) for cross over design.
Intervention: All three groups received 4 weeks training (2 sessions/week, 50 minutes/session), including upper extremity and balance exercises.
Main outcome measures: The assessments were performed at baseline (pre), after 4 weeks (post) and after 7 weeks (follow-up). The measures for physical function included Stroke Rehabilitation Assessment (STREAM), Postural Assessment Scale for Stroke Patients (PASS), and Barthel index (BI). The measures for satisfaction included Stroke Impact Scale (SIS) and user-satisfaction questionnaires.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Taipei, Tajwan, 100
- School and Graduate Institute of Physical Therapy, National Taiwan University
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Having a first episode of unilateral stroke with hemiparesis,
- Brunnstrom score between stages II and VI for the upper and lower hemiplegic extremities,
- Being able to understand and follow simple verbal instructions.
Exclusion Criteria:
- Those with other major diseases (e.g., Parkinson disease and severe osteoarthritis) and unstable medical conditions during the study period.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: telerehabilitation
telerehabilitation via internet
|
telerehabilitation for 4 weeks, 2 sessions per week and 30 to 50 minutes per session
Inne nazwy:
|
Brak interwencji: conventional
conventional therapy
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Changes of Berg Balance Scale
Ramy czasowe: 1 month
|
To measure static and dynamic balance during daily activities
|
1 month
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Changes of Stroke Impact Scale (SIS)
Ramy czasowe: 1 month
|
the quality of life questionnaire
|
1 month
|
Współpracownicy i badacze
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 200809040R
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Uderzenie
-
University of ZurichNieznany