NCT04419753

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

June 2, 2020

Last Update Submit

June 11, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

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

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

    At Day 0, Month 1, and Month 7

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

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

    At Day 0, Month 1, and Month 7

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

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

    At Day 0, Month 1, and Month 7

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

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

    At Day 0, Month 1, and Month 7

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

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

    At Day 0, Month 1, and Month 7

Secondary Outcomes (4)

  • 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

  • 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

  • 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

Study Arms (3)

No Attention Focus Walking Group (NAFWG)

ACTIVE COMPARATOR

In each training session, the NAFWG 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 without attention focus instruction (20 minutes) and cool down (5 minutes).

Behavioral: attention focus walking training

External Attention Focus Walking Group (EAFWG)

EXPERIMENTAL

In each training session, the EAFWG 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 external attention focus instructions (20 minutes) and cool down (5 minutes).

Behavioral: attention focus walking training

Internal Attention Focus Walking Group (IAFWG)

EXPERIMENTAL

In each training session, the IAFWG 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 internal attention focus instructions (20 minutes) and cool down (5 minutes).

Behavioral: attention focus walking training

Interventions

Use different attention focus instructions or no attention focus instruction during walking training in older adults to examine whether the attention focus instructions can ameliorate conscious motor processing and optimize rehabilitation outcome measurements.

External Attention Focus Walking Group (EAFWG)Internal Attention Focus Walking Group (IAFWG)No Attention Focus Walking Group (NAFWG)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Hong Kong

Location

Related Publications (1)

  • Mak TCT, Ng SSM, Leung MCY, Wong TWL. Examining the role of attention focus walking training on conscious motor processing during rehabilitation by older adults at risk of falling: A randomized controlled trial. Arch Gerontol Geriatr. 2024 Jun;121:105352. doi: 10.1016/j.archger.2024.105352. Epub 2024 Jan 28.

Study Officials

  • Thomson Wai Lung WONG, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomson Wai Lung WONG, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Honorary Assistant Professor

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 5, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations