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临床试验/NCT04419753
NCT04419753Unknown不适用

Examining the Role of External and Internal Attention Focus Walking Training on Conscious Motor Processing During Rehabilitation by Older Adults at Risk of Falling in Hong Kong: A Randomized Controlled Trial.

Dr. Thomson Wai-Lung Wong1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2020年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
108
试验地点
1
主要终点
Change from Baseline Functional balance ability at 1 month (post-training) and 7 months (6 months post-training)

研究概览

简要总结

This study aims to examine the effect of external, internal and no attention focus walking training during gait rehabilitation on real-time conscious motor processing (reinvestment), balance, walking ability and fear of falling by older adults at risk of falling in Hong Kong.

One-hundred and eight older adults will be recruited from elderly community centers in Hong Kong. Participants will be randomly assigned into 3 groups (i.e., No Attention Focus Walking Group (NAFWG; active control group, n=36), an External Attention Focus Walking Group (EAFWG, n = 36) or an Internal Attention Focus Walking Group (IAFWG, n = 36)). Participants in different groups will have training sessions (about 45 minutes each) three times per week for 4 weeks in a group of 6 participants. A total of 12 sessions will be completed by each participant.

All training sessions will be conducted by experienced registered physiotherapists in Hong Kong and a research assistant with experience in exercise training for older adults. 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 levels of difficulties in a 40-meter walkway with different instructions in different walking groups (20 minutes) and cool down (5 minutes). For the walking training (20 minutes), all participants will be invited to conduct walking training on a walking field with an area of 25 meter square and a total walking distance of about 40 meters for each walking trial from cone 1 to 9. Two screens that connected with a laptop computer will be positioned 1 meter beside the walking field. Both screens will be projected different digits from 0 to 9 randomly in the speed of 2 seconds per digit. Participants in the NAFWG, EAFWG, and IAFWG will receive different instructions during walking training.

Each participant will complete 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 (T0), a structural questionnaire will be used to ask for demographics, medical history, detailed history of fall incident, social history and social economic status of all participants. A battery of assessments will be conducted to assess physical and cognitive abilities of the participants in all assessment sessions (T0, T1, & T2). Walking ability will be assessed by the 10 meters comfortable and fast walking speed (Bohannon, 1997). Functional balance and gait assessment will be done by the Tinetti Balance Assessment Tool (Tinetti, 1986), the Berg Balance Scale (BBS) (Berg et al., 1989) and the Timed 'Up & Go' Tests (TU&G) (Podsiadlo & Richardson, 1991). Cognitive function will be evaluated by the Chinese version Mini-Mental State Examination (MMSE-C) (Folstein et al., 1975; Chiu et al., 1994). The Chinese version of the Fall Efficacy Scale International (FES-I (Ch)) (Kwan, Tsang, Close & Lord, 2013) will be completed to assess the fear of falling. The Chinese version Movement Specific Reinvestment Scale (MSRS-C) (Masters et al., 2005; Wong et al., 2015a; Wong et al., 2015b) will be administered to examine the conscious motor processing propensity (i.e., movement specific reinvestment). The alpha2 EEG coherence between T3 (verbal-analytical region of the brain) and the Fz (motor planning region of the brain) (i.e., T3-Fz EEG coherence) of all participants when walking at the 6-meter level-ground walkway (three walking trials) will be determined to identify the real-time conscious motor processing propensity (Zhu et al., 2011; Ellmers et al., 2016; Chu & Wong, 2019). All participants will be equipped with EEG electrodes before the start of the three walking trials. EEG activity will be received using a wireless EEG device (Brainquiry PET 4.0, Brainquiry, The Netherlands) and will be recorded using the real-time biophysical data acquisition software (BioExplorer 1.5, CyberEvolution, US). Previous research has demonstrated that alpha2 (10-12Hz) T3-Fz EEG coherence is sensitive at detecting within-subject changes in real-time conscious motor processing propensity during a postural sway task (Ellmers et al., 2016). T4-Fz EEG coherence will be utilized to identify whether the changes in the alpha2 T3-Fz EEG coherence will be due to global activation of the brain. The EEG electrodes are non-invasive and will not be used in any diagnostic purpose.

All participants will 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 structural calendar. The number of falls within the 6-month follow-up period will then be collected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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) total score of equal or more than 24;
  • Able to walk independently indoor for at least 40 meters continuously with comfortable pace;
  • 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.

排除标准

  • Any potential participant who cannot meet the inclusion criteria.

结局指标

主要结局

Change from Baseline Functional balance ability at 1 month (post-training) and 7 months (6 months post-training)

时间窗: At Day 0, Month 1, and Month 7

will be assessed by the Berg Balance Scale (BBS) (Berg et al., 1989).

Change from Baseline Functional balance and gait ability at 1 month (post-training) and 7 months (6 months post-training)

时间窗: At Day 0, Month 1, and Month 7

will be assessed by the Tinetti Balance Assessment Tool (Tinetti, 1986).

Change from Baseline Walking ability at 1 month (post-training) and 7 months (6 months post-training)

时间窗: At Day 0, Month 1, and Month 7

will be assessed by the 10 meters comfortable and fast walking speed (Bohannon, 1997).

Change from Baseline Real-time conscious motor processing propensity at 1 month (post-training) and 7 months (6 months post-training)

时间窗: At Day 0, Month 1, and Month 7

will be measured by the Alpha 2 T3-Fz EEG coherence (Zhu et al., 2011; Ellmers et al., 2016; Chu \& Wong, 2019).

Change from Baseline Functional gait ability at 1 month (post-training) and 7 months (6 months post-training)

时间窗: At Day 0, Month 1, and Month 7

will be assessed by the Timed 'Up \& Go' Tests (TU\&G) (Podsiadlo \& Richardson, 1991).

次要结局

  • Cognitive function(At Day 0)
  • Change from Baseline Visuo-spatial involvement in movement control at 1 month (post-training) and 7 months (6 months post-training)(At Day 0, Month 1, and Month 7)
  • Change from Baseline Fear of falling at 1 month (post-training) and 7 months (6 months post-training)(At Day 0, Month 1, and Month 7)
  • Change from Baseline Conscious motor processing propensity (i.e., movement specific reinvestment) at 1 month (post-training) and 7 months (6 months post-training)(At Day 0, Month 1, and Month 7)

研究者

发起方
Dr. Thomson Wai-Lung Wong
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Thomson Wai-Lung Wong

Honorary Assistant Professor

The University of Hong Kong

研究点 (1)

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