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Effect of Single-task, Dual-task and Analogy Training During Gait Rehabilitation

23 de marzo de 2020 actualizado por: Dr. Thomson Wai-Lung Wong, The University of Hong Kong

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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

105

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Hong Kong, Hong Kong
        • Reclutamiento
        • The HKJC Building for Interdisciplinary Research
        • Contacto:
          • Thomson Wong

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Single-task Training Group
Single-task walking group
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).
Experimental: Dual-task Training Group
Dual-task walking group
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).
Experimental: Analogy Training Group
Analogy walking group
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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Baseline propensity for conscious motor processing
Periodo de tiempo: Before the start of training
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.
Before the start of training
Change from baseline propensity for conscious motor processing upon completion of training
Periodo de tiempo: Upon completion of 12 Training Sessions (4 weeks of training)
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.
Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline propensity for conscious motor processing at 6 months after the completion of training
Periodo de tiempo: 6 months after the completion of Training
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.
6 months after the completion of Training

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Baseline single-task walking ability
Periodo de tiempo: Before the start of training
10 meters comfortable and fast walking speed (Bohannon, 1997)
Before the start of training
Change from baseline single-task walking ability upon completion of training
Periodo de tiempo: Upon completion of 12 Training Sessions (4 weeks of training)
10 meters comfortable and fast walking speed (Bohannon, 1997)
Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline single-task walking ability at 6 months after the completion of training
Periodo de tiempo: 6 months after the completion of Training
10 meters comfortable and fast walking speed (Bohannon, 1997)
6 months after the completion of Training
Baseline dual-task walking ability
Periodo de tiempo: Before the start of training
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)
Before the start of training
Change from baseline dual-task walking ability upon completion of training
Periodo de tiempo: Upon completion of 12 Training Sessions (4 weeks of training)
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)
Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline dual-task walking ability at 6 months after the completion of training
Periodo de tiempo: 6 months after the completion of Training
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)
6 months after the completion of Training
Baseline Tinetti Balance Assessment Tool score
Periodo de tiempo: Before the start of training
Tinetti Balance Assessment Tool (Tinetti, 1986).
Before the start of training
Change from baseline Tinetti Balance Assessment Tool score upon completion of training
Periodo de tiempo: Upon completion of 12 Training Sessions (4 weeks of training)
Tinetti Balance Assessment Tool (Tinetti, 1986)
Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline Tinetti Balance Assessment Tool score at 6 months after the completion of training
Periodo de tiempo: 6 months after the completion of Training
Tinetti Balance Assessment Tool (Tinetti, 1986)
6 months after the completion of Training
Baseline Timed 'Up & Go' Tests time
Periodo de tiempo: Before the start of training
Timed 'Up & Go' Tests (TU&G(Podsiadlo & Richardson, 1991)
Before the start of training
Change from baseline Timed 'Up & Go' Tests time upon completion of training
Periodo de tiempo: Upon completion of 12 Training Sessions (4 weeks of training)
Timed 'Up & Go' Tests (TU&G(Podsiadlo & Richardson, 1991)
Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline Timed 'Up & Go' Tests time at 6 months after the completion of training
Periodo de tiempo: 6 months after the completion of Training
Timed 'Up & Go' Tests (TU&G(Podsiadlo & Richardson, 1991)
6 months after the completion of Training
Baseline Berg Balance Scale score
Periodo de tiempo: Before the start of training
Berg Balance Scale (BBS) (Berg, Wood Dauphinee, Williams & Gayton, 1989)
Before the start of training
Change from baseline Berg Balance Scale score upon completion of training
Periodo de tiempo: Upon completion of 12 Training Sessions (4 weeks of training)
Berg Balance Scale (BBS) (Berg, Wood Dauphinee, Williams & Gayton, 1989)
Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline Berg Balance Scale score at 6 months after the completion of training
Periodo de tiempo: 6 months after the completion of Training
Berg Balance Scale (BBS) (Berg, Wood Dauphinee, Williams & Gayton, 1989)
6 months after the completion of Training
Cognitive function
Periodo de tiempo: Before the start of training
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.
Before the start of training
Baseline fear of falling
Periodo de tiempo: Before the start of training
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.
Before the start of training
Change from baseline fear of falling upon completion of training
Periodo de tiempo: Upon completion of 12 Training Sessions (4 weeks of training)
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.
Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline fear of falling at 6 months after the completion of training
Periodo de tiempo: 6 months after the completion of Training
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.
6 months after the completion of Training
Number of falls between T1 and T2 (post training to 6 months after completion of training)
Periodo de tiempo: 6 months after the completion of Training
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.
6 months after the completion of Training

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Thomson Wai Lung WONG, The University of Hong Kong

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de octubre de 2018

Finalización primaria (Anticipado)

31 de agosto de 2021

Finalización del estudio (Anticipado)

31 de agosto de 2021

Fechas de registro del estudio

Enviado por primera vez

10 de enero de 2019

Primero enviado que cumplió con los criterios de control de calidad

18 de enero de 2019

Publicado por primera vez (Actual)

22 de enero de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de marzo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

23 de marzo de 2020

Última verificación

1 de marzo de 2020

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Single-task Training

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