- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03811782
Effect of Single-task, Dual-task and Analogy Training During Gait Rehabilitation
Examining Conscious Motor Processing and the Effect of Single-task, Dual-task and Analogy Training on Walking During Rehabilitation by Older Adults at Risk of Falling in Hong Kong: A Randomized Controlled Trial
The study aims to examine the effect of single-task, dual-task and analogy training during gait rehabilitation on conscious motor processing propensity, balance, walking ability and fear of falling by older adults at risk of falling in Hong Kong. One-hundred and five healthy older adults will be recruited from elderly community centres in Hong Kong by convenience sampling. They will be randomly assigned into 3 groups (i.e., single-task walking group (active control group), dual-task walking group and analogy walking group). Participants in different groups will have training sessions (about 45 minutes each) three times per week for 4 weeks in a group of 5 participants. A total of 12 sessions will be completed by each participant. All training sessions will be conducted by experienced Hong Kong registered Physiotherapists. In each training session, all groups will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various difficulties in a 10 meters walkway with different instructions in different walking groups (20 minutes) and cool down (5 minutes). Participants in the different groups will receive different instructions during walking training. Well- developed single-task (explicit), dual-task and analogy instructions will be utilized in the single-task walking group, dual-task walking group and analogy walking group, respectively. Each participant will undergo assessment sessions (total 3 assessment sessions) before training at baseline (T0), just after completion of all training sessions (T1) and 6 months after completion of all training sessions (T2). In the baseline assessment, a structural questionnaire will be used to ask for demographics, detailed history of fall incident, detailed medical history, social history and social-economic status of the participants. A battery of assessments will be done to assess physical and cognitive abilities of the participants in all assessment sessions. Single-task walking ability, dual-task walking ability, functional gait and balance assessment, cognitive function, fearing of falling and propensity for conscious motor processing.
All participants will also be asked to record their number of falls prospectively at the time between T1 (completion of all training sessions) and T2 (6 months after completion of all training sessions) using a calendar. The number of falls within the 6-month follow- up period will then be collected.
Обзор исследования
Статус
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Hong Kong, Гонконг
- Рекрутинг
- The HKJC Building for Interdisciplinary Research
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Контакт:
- Thomson Wong
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age 65 or above;
- No history of cerebral vascular disease, Parkinson's disease or other neurological deficit;
- Chinese version of the Mini-Mental State Examination (MMSE-C) (Folstein, Folstein, & McHuge, 1975; Chiu, Lee, Chung, & Kwong, 1994) total score of equal or more than 24;
- Able to walk independently indoor for at least 10 meters;
- Older adults with moderate to high risk of falling, as indicated by the score of less than 24 out of 28 in the Tinetti Balance Assessment Tool (Tinetti, 1986).
Exclusion Criteria:
- Any potential participant who cannot meet the inclusion criteria.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Single-task Training Group
Single-task walking group
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In each training session, all groups will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various difficulties in a 10 meters walkway with Single-task Training instructions (20 minutes) and cool down (5 minutes).
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Экспериментальный: Dual-task Training Group
Dual-task walking group
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In each training session, all groups will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various difficulties in a 10 meters walkway with Dual-task Training instructions (20 minutes) and cool down (5 minutes).
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Экспериментальный: Analogy Training Group
Analogy walking group
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In each training session, all groups will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various difficulties in a 10 meters walkway with Analogy Training instructions (20 minutes) and cool down (5 minutes).
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Baseline propensity for conscious motor processing
Временное ограничение: Before the start of training
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The Chinese version Movement Specific Reinvestment Scale (MSRS-C) (Masters et al., 2005; Wong et al., 2015a; Wong et al., 2015b).
The MSRS-C includes two sub-scales: Conscious motor processing and Movement self-consciousness.
The scores for both sub-scales ranges from 5-30.
A higher score indicate a higher propensity for conscious motor processing.
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Before the start of training
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Change from baseline propensity for conscious motor processing upon completion of training
Временное ограничение: Upon completion of 12 Training Sessions (4 weeks of training)
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The Chinese version Movement Specific Reinvestment Scale (MSRS-C) (Masters et al., 2005; Wong et al., 2015a; Wong et al., 2015b).
The MSRS-C includes two sub-scales: Conscious motor processing and Movement self-consciousness.
The scores for both sub-scales ranges from 5-30.
A higher score indicate a higher propensity for conscious motor processing.
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Upon completion of 12 Training Sessions (4 weeks of training)
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Change from baseline propensity for conscious motor processing at 6 months after the completion of training
Временное ограничение: 6 months after the completion of Training
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The Chinese version Movement Specific Reinvestment Scale (MSRS-C) (Masters et al., 2005; Wong et al., 2015a; Wong et al., 2015b).
The MSRS-C includes two sub-scales: Conscious motor processing and Movement self-consciousness.
The scores for both sub-scales ranges from 5-30.
A higher score indicate a higher propensity for conscious motor processing.
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6 months after the completion of Training
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Baseline single-task walking ability
Временное ограничение: Before the start of training
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10 meters comfortable and fast walking speed (Bohannon, 1997)
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Before the start of training
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Change from baseline single-task walking ability upon completion of training
Временное ограничение: Upon completion of 12 Training Sessions (4 weeks of training)
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10 meters comfortable and fast walking speed (Bohannon, 1997)
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Upon completion of 12 Training Sessions (4 weeks of training)
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Change from baseline single-task walking ability at 6 months after the completion of training
Временное ограничение: 6 months after the completion of Training
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10 meters comfortable and fast walking speed (Bohannon, 1997)
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6 months after the completion of Training
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Baseline dual-task walking ability
Временное ограничение: Before the start of training
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10 meters comfortable and fast walking speed with concurrent verbal or visual-spatial dual-tasks of auditory stroop task (Siu, Catena, Chou, van Donkelaar, & Woollacott, 2008) or clock test (Plummer-D'Amato, Altmann, Saracino, Fox, Behrman, & Marsiske, 2008)
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Before the start of training
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Change from baseline dual-task walking ability upon completion of training
Временное ограничение: Upon completion of 12 Training Sessions (4 weeks of training)
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10 meters comfortable and fast walking speed with concurrent verbal or visual-spatial dual-tasks of auditory stroop task (Siu, Catena, Chou, van Donkelaar, & Woollacott, 2008) or clock test (Plummer-D'Amato, Altmann, Saracino, Fox, Behrman, & Marsiske, 2008)
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Upon completion of 12 Training Sessions (4 weeks of training)
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Change from baseline dual-task walking ability at 6 months after the completion of training
Временное ограничение: 6 months after the completion of Training
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10 meters comfortable and fast walking speed with concurrent verbal or visual-spatial dual-tasks of auditory stroop task (Siu, Catena, Chou, van Donkelaar, & Woollacott, 2008) or clock test (Plummer-D'Amato, Altmann, Saracino, Fox, Behrman, & Marsiske, 2008)
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6 months after the completion of Training
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Baseline Tinetti Balance Assessment Tool score
Временное ограничение: Before the start of training
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Tinetti Balance Assessment Tool (Tinetti, 1986).
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Before the start of training
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Change from baseline Tinetti Balance Assessment Tool score upon completion of training
Временное ограничение: Upon completion of 12 Training Sessions (4 weeks of training)
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Tinetti Balance Assessment Tool (Tinetti, 1986)
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Upon completion of 12 Training Sessions (4 weeks of training)
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Change from baseline Tinetti Balance Assessment Tool score at 6 months after the completion of training
Временное ограничение: 6 months after the completion of Training
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Tinetti Balance Assessment Tool (Tinetti, 1986)
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6 months after the completion of Training
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Baseline Timed 'Up & Go' Tests time
Временное ограничение: Before the start of training
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Timed 'Up & Go' Tests (TU&G(Podsiadlo & Richardson, 1991)
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Before the start of training
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Change from baseline Timed 'Up & Go' Tests time upon completion of training
Временное ограничение: Upon completion of 12 Training Sessions (4 weeks of training)
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Timed 'Up & Go' Tests (TU&G(Podsiadlo & Richardson, 1991)
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Upon completion of 12 Training Sessions (4 weeks of training)
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Change from baseline Timed 'Up & Go' Tests time at 6 months after the completion of training
Временное ограничение: 6 months after the completion of Training
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Timed 'Up & Go' Tests (TU&G(Podsiadlo & Richardson, 1991)
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6 months after the completion of Training
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Baseline Berg Balance Scale score
Временное ограничение: Before the start of training
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Berg Balance Scale (BBS) (Berg, Wood Dauphinee, Williams & Gayton, 1989)
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Before the start of training
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Change from baseline Berg Balance Scale score upon completion of training
Временное ограничение: Upon completion of 12 Training Sessions (4 weeks of training)
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Berg Balance Scale (BBS) (Berg, Wood Dauphinee, Williams & Gayton, 1989)
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Upon completion of 12 Training Sessions (4 weeks of training)
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Change from baseline Berg Balance Scale score at 6 months after the completion of training
Временное ограничение: 6 months after the completion of Training
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Berg Balance Scale (BBS) (Berg, Wood Dauphinee, Williams & Gayton, 1989)
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6 months after the completion of Training
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Cognitive function
Временное ограничение: Before the start of training
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The Chinese version Mini-Mental State Examination (MMSE-C) (Folstein et al., 1975; Chiu et al., 1994).
A mark of 24 or above out of 30 is required to meet the inclusion criteria.
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Before the start of training
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Baseline fear of falling
Временное ограничение: Before the start of training
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Fall Efficacy Scale (FES-13) (Tinetti, Richman, & Powell L, 1990; Tinetti, Leon, Doucette & Parker, 1994; Hellström & Lindmark, 1999).
The FES-13 score ranges from 16-64.
A higher score indicates greater fear of falling.
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Before the start of training
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Change from baseline fear of falling upon completion of training
Временное ограничение: Upon completion of 12 Training Sessions (4 weeks of training)
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Fall Efficacy Scale (FES-13) (Tinetti, Richman, & Powell L, 1990; Tinetti, Leon, Doucette & Parker, 1994; Hellström & Lindmark, 1999).
The FES-13 score ranges from 16-64.
A higher score indicates greater fear of falling.
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Upon completion of 12 Training Sessions (4 weeks of training)
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Change from baseline fear of falling at 6 months after the completion of training
Временное ограничение: 6 months after the completion of Training
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Fall Efficacy Scale (FES-13) (Tinetti, Richman, & Powell L, 1990; Tinetti, Leon, Doucette & Parker, 1994; Hellström & Lindmark, 1999).
The FES-13 score ranges from 16-64.
A higher score indicates greater fear of falling.
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6 months after the completion of Training
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Number of falls between T1 and T2 (post training to 6 months after completion of training)
Временное ограничение: 6 months after the completion of Training
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Record of the the number of falls prospectively at the time between T1 (completion of all training sessions) and T2 (6 months after completion of all training sessions) using a calendar.
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6 months after the completion of Training
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Thomson Wai Lung WONG, The University of Hong Kong
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- UW17-049
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
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