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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03811782
Other study ID # UW17-049
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date August 31, 2021

Study information

Verified date March 2020
Source The University of Hong Kong
Contact Thomson Wai Lung WONG
Phone (852) 28315258
Email wongtwl@hku.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 105
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Single-task Training
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).
Dual-task Training
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).
Analogy Training
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).

Locations

Country Name City State
Hong Kong The HKJC Building for Interdisciplinary Research Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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)
Primary 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 Baseline single-task walking ability 10 meters comfortable and fast walking speed (Bohannon, 1997) Before the start of training
Secondary Change from baseline single-task walking ability upon completion of training 10 meters comfortable and fast walking speed (Bohannon, 1997) Upon completion of 12 Training Sessions (4 weeks of training)
Secondary Change from baseline single-task walking ability at 6 months after the completion of training 10 meters comfortable and fast walking speed (Bohannon, 1997) 6 months after the completion of Training
Secondary Baseline dual-task walking ability 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
Secondary Change from baseline dual-task walking ability upon 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) Upon completion of 12 Training Sessions (4 weeks of training)
Secondary Change from baseline dual-task walking ability at 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
Secondary Baseline Tinetti Balance Assessment Tool score Tinetti Balance Assessment Tool (Tinetti, 1986). Before the start of training
Secondary Change from baseline Tinetti Balance Assessment Tool score upon completion of training Tinetti Balance Assessment Tool (Tinetti, 1986) Upon completion of 12 Training Sessions (4 weeks of training)
Secondary Change from baseline Tinetti Balance Assessment Tool score at 6 months after the completion of training Tinetti Balance Assessment Tool (Tinetti, 1986) 6 months after the completion of Training
Secondary Baseline Timed 'Up & Go' Tests time Timed 'Up & Go' Tests (TU&G(Podsiadlo & Richardson, 1991) Before the start of training
Secondary Change from baseline Timed 'Up & Go' Tests time upon completion of training Timed 'Up & Go' Tests (TU&G(Podsiadlo & Richardson, 1991) Upon completion of 12 Training Sessions (4 weeks of training)
Secondary Change from baseline Timed 'Up & Go' Tests time at 6 months after the completion of training Timed 'Up & Go' Tests (TU&G(Podsiadlo & Richardson, 1991) 6 months after the completion of Training
Secondary Baseline Berg Balance Scale score Berg Balance Scale (BBS) (Berg, Wood Dauphinee, Williams & Gayton, 1989) Before the start of training
Secondary Change from baseline Berg Balance Scale score upon completion of training Berg Balance Scale (BBS) (Berg, Wood Dauphinee, Williams & Gayton, 1989) Upon completion of 12 Training Sessions (4 weeks of training)
Secondary Change from baseline Berg Balance Scale score at 6 months after the completion of training Berg Balance Scale (BBS) (Berg, Wood Dauphinee, Williams & Gayton, 1989) 6 months after the completion of Training
Secondary Cognitive function 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
Secondary Baseline fear of falling Fall Efficacy Scale (FES-13) (Tinetti, Richman, & Powell L, 1990; Tinetti, Leon, Doucette & Parker, 1994; Hellstro¨m & Lindmark, 1999). The FES-13 score ranges from 16-64. A higher score indicates greater fear of falling. Before the start of training
Secondary Change from baseline fear of falling upon completion of training Fall Efficacy Scale (FES-13) (Tinetti, Richman, & Powell L, 1990; Tinetti, Leon, Doucette & Parker, 1994; Hellstro¨m & 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)
Secondary Change from baseline fear of falling at 6 months after the completion of training Fall Efficacy Scale (FES-13) (Tinetti, Richman, & Powell L, 1990; Tinetti, Leon, Doucette & Parker, 1994; Hellstro¨m & 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
Secondary Number of falls between T1 and T2 (post training to 6 months after 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
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