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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05411536
Other study ID # 15601021
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 15, 2022
Est. completion date June 30, 2024

Study information

Verified date February 2024
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to provide a novel scientific contribution through addressing critical knowledge gaps, examining the effects of attentional focus instructions on real-time (state) conscious movement processing propensity, gait parameters, and muscle efficiency in older adults in Hong Kong at risk of falling while walking in a challenging environment. The study results could update our scientific understanding of the mechanisms of conscious movement processing and the interventional effects of attentional focus instructions in older adults. It could ultimately enhance the methodology used for developing the most appropriate psychomotor gait re-education intervention in rehabilitation and provide clear guidelines on the exact attentional focus training that older adults require. Further, it could mitigate the effect of conscious movement processing and risk of falling in older adults.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 106
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 99 Years
Eligibility Inclusion Criteria: - age 65 or above; - able to walk independently indoor for at least 20 metres without a walking aid. Exclusion Criteria: - a total score of less than 24 on the MMSE-C (Chiu et al., 1994; Folstein et al., 1975); - the presence of any untreated cerebral vascular disease, Parkinson's disease, or any other major neurological deficit; - the presence of an unstable medical condition affecting safety while walking ; - a history of a major fall incident within the last year; - a static visual acuity poorer than 20/40 vision (assessed using the Tumbling E eye chart).

Study Design


Intervention

Other:
Walking trials
All participants will complete a series of walking trials. They will first be requested to perform three practice walks followed by three walking trials on a 7.4m straight level-ground firm walkway (GW) and the other three walking trials on a 7.4m straight foam walkway (FW) in a randomised order. The dimension of the foam walkway in the FW will be 8m (length), 0.8m (width), and 0.3m (height). The starting and finishing lines of the FW will be positioned at 0.3m from each side of the FW's edges. Thus, the lengths of the FW and the GW will be identical (i.e., 7.4m). Participants will be asked to walk 7.4m and stop for each walking trial. After a 10-minute rest break, participants will perform nine walking trials on the GW and the other nine walking trials on the FW, including three repetitions of three different attentional focus instructions (external focus [EF], internal focus [IF], and no specific focus [NF]) in the GW and FW in a randomised order.

Locations

Country Name City State
China The Hong Kong Polytechnic University Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Real-time (state) conscious movement processing propensity It will be measured by the Alpha2 EEG T3-Fz coherence. Day 0
Primary Gait speed It will be measured by the 3-D motion-capture system in the unit of meter per second (m/s). Day 0
Primary Body sway It will be measured by the 3-D motion-capture system in the unit of millimeter (mm). Day 0
Primary Stride length It will be measured by the 3-D motion-capture system in the unit of meter (m). Day 0
Primary Stride-to-stride variability It will be measured by the 3-D motion-capture system by the coefficients of variation (CV). Day 0
Primary Muscle efficiency It will be measured by the surface electromyography (EMG). Day 0
Secondary Walking ability It will be measured by the Timed 'Up & Go' tests. Day 0
Secondary Balance ability It will be measured by the Berg Balance Scale. The minimum value of the scale is 0 and the maximum value is 56. Higher score represents better balance ability. Day 0
Secondary Fear of falling It will be measured by the Chinese version of the Falls Efficacy Scale International. The minimum value of the scale is 16 and the maximum value is 64. Higher score represents higher fear of falling. Day 0
Secondary Trait conscious movement processing propensity It will be measured by the Chinese version of the Movement-Specific Reinvestment Scale. The minimum value of the scale is 10 and the maximum value is 60. Higher score represents higher trait conscious movement processing propensity. Day 0
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