NCT03811782

Brief Summary

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.

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
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

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

Study Start

First participant enrolled

October 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

2.9 years

First QC Date

January 10, 2019

Last Update Submit

March 23, 2020

Conditions

Keywords

conscious motor processingsingle-task trainingdual-task traininganalogy traininggait rehabilitationreinvestment propensitybalancefear of fallingolder adultsHong Kong

Outcome Measures

Primary Outcomes (3)

  • Baseline propensity for conscious motor processing

    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

    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

    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

Secondary Outcomes (20)

  • Baseline single-task walking ability

    Before the start of training

  • Change from baseline single-task walking ability upon completion of training

    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

    6 months after the completion of Training

  • Baseline dual-task walking ability

    Before the start of training

  • Change from baseline dual-task walking ability upon completion of training

    Upon completion of 12 Training Sessions (4 weeks of training)

  • +15 more secondary outcomes

Study Arms (3)

Single-task Training Group

EXPERIMENTAL

Single-task walking group

Behavioral: Single-task Training

Dual-task Training Group

EXPERIMENTAL

Dual-task walking group

Behavioral: Dual-task Training

Analogy Training Group

EXPERIMENTAL

Analogy walking group

Behavioral: Analogy Training

Interventions

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).

Single-task Training 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).

Dual-task Training 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).

Analogy Training Group

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) (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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The HKJC Building for Interdisciplinary Research

Hong Kong, Hong Kong

RECRUITING

Study Officials

  • Thomson Wai Lung WONG

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomson Wai Lung WONG

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 22, 2019

Study Start

October 1, 2018

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations