FallNCT03811782
Effect of Single-task, Dual-task and Analogy Training During Gait Rehabilitation
A study testing Single-task Training, Dual-task Training and Analogy Training in people with Fall and Balance, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Balance, Reinvestment Propensity
- What is being tested?
- Single-task Training, Dual-task Training and Analogy Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2018to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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).
Who cannot join
- Any potential participant who cannot meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The HKJC Building for Interdisciplinary Research
Hong Kong
Thomson Wong
About this study
Official title: Examining Conscious Motor Processing and the Effect of Single-task, Dual-task and Analogy Training on Walking During Rehabilitation by Older Adults at Risk of Falling in Hong Kong: A Randomized Controlled Trial
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.
- Conditions
- Fall, Balance, Reinvestment Propensity, Gait Rehabilitation
- Being tested
- Single-task Training, Dual-task Training, Analogy Training
- Keywords
- conscious motor processing, single-task training, dual-task training, analogy training, gait rehabilitation, reinvestment propensity, balance, fear of falling, older adults, Hong Kong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-task TrainingBehavioural
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 TrainingBehavioural
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 TrainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Single-task Training Group | Experimental | Single-task walking group Receives: Behavioral: Single-task Training |
| Dual-task Training Group | Experimental | Dual-task walking group Receives: Behavioral: Dual-task Training |
| Analogy Training Group | Experimental | Analogy walking group Receives: Behavioral: Analogy Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months after the completion of Training
Secondary outcomes (20)
Baseline single-task walking ability
10 meters comfortable and fast walking speed (Bohannon, 1997)
Measured: Before the start of training
Change from baseline single-task walking ability upon completion of training
10 meters comfortable and fast walking speed (Bohannon, 1997)
Measured: 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
10 meters comfortable and fast walking speed (Bohannon, 1997)
Measured: 6 months after the completion of Training
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)
Measured: Before the start of training
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)
Measured: Upon completion of 12 Training Sessions (4 weeks of training)
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)
Measured: 6 months after the completion of Training
Baseline Tinetti Balance Assessment Tool score
Tinetti Balance Assessment Tool (Tinetti, 1986).
Measured: Before the start of training
Change from baseline Tinetti Balance Assessment Tool score upon completion of training
Tinetti Balance Assessment Tool (Tinetti, 1986)
Measured: Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline Tinetti Balance Assessment Tool score at 6 months after the completion of training
Tinetti Balance Assessment Tool (Tinetti, 1986)
Measured: 6 months after the completion of Training
Baseline Timed 'Up & Go' Tests time
Timed 'Up \& Go' Tests (TU\&G(Podsiadlo \& Richardson, 1991)
Measured: Before the start of training
Change from baseline Timed 'Up & Go' Tests time upon completion of training
Timed 'Up \& Go' Tests (TU\&G(Podsiadlo \& Richardson, 1991)
Measured: Upon completion of 12 Training Sessions (4 weeks of training)
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)
Measured: 6 months after the completion of Training
Baseline Berg Balance Scale score
Berg Balance Scale (BBS) (Berg, Wood Dauphinee, Williams \& Gayton, 1989)
Measured: Before the start of training
Change from baseline Berg Balance Scale score upon completion of training
Berg Balance Scale (BBS) (Berg, Wood Dauphinee, Williams \& Gayton, 1989)
Measured: Upon completion of 12 Training Sessions (4 weeks of training)
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)
Measured: 6 months after the completion of Training
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.
Measured: Before the start of training
Baseline fear of falling
Fall Efficacy Scale (FES-13) (Tinetti, Richman, \& Powell L, 1990; Tinetti, Leon, Doucette \& Parker, 1994; Hellström \& Lindmark, 1999). The FES-13 score ranges from 16-64. A higher score indicates greater fear of falling.
Measured: Before the start of training
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; Hellström \& Lindmark, 1999). The FES-13 score ranges from 16-64. A higher score indicates greater fear of falling.
Measured: Upon completion of 12 Training Sessions (4 weeks of training)
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; Hellström \& Lindmark, 1999). The FES-13 score ranges from 16-64. A higher score indicates greater fear of falling.
Measured: 6 months after the completion of Training
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.
Measured: 6 months after the completion of Training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Oct 2018
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Thomson Wai-Lung Wong, The University of Hong Kong
- Investigators
- Thomson Wai Lung WONG, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811782
- Sponsor's protocol ID
- UW17-049
- Status last verified
- Mar 2020
- First submitted
- 10 Jan 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Conscious Motor Processing and the Effect of Single-task, Dual-task and Analogy Training on Walking During Rehabilitation by Older Adults at Risk of Falling in Hong Kong: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03811782
- Acronym / sponsor ID
- UW17-049
- Conditions
- Fall, Balance, Reinvestment Propensity, Gait Rehabilitation
- Keywords
- conscious motor processing, single-task training, dual-task training, analogy training, gait rehabilitation, reinvestment propensity, balance, fear of falling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single-task Training Group | Experimental | Behavioral: Single-task TrainingSingle-task walking group |
| Dual-task Training Group | Experimental | Behavioral: Dual-task TrainingDual-task walking group |
| Analogy Training Group | Experimental | Behavioral: Analogy TrainingAnalogy walking group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- Any potential participant who cannot meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-task TrainingIn 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). | Behavioural | Single-task Training Group |
| Dual-task TrainingIn 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). | Behavioural | Dual-task Training Group |
| Analogy TrainingIn 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). | Behavioural | Analogy Training Group |
Primary outcome
Baseline propensity for conscious motor processing
Time frame: Before the start 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.
Change from baseline propensity for conscious motor processing upon completion of training
Time frame: Upon completion of 12 Training Sessions (4 weeks 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.
Change from baseline propensity for conscious motor processing at 6 months after the completion of training
Time frame: 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.
20 secondary outcomes
Baseline single-task walking ability
Time frame: Before the start of training
Change from baseline single-task walking ability upon completion of training
Time frame: 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
Time frame: 6 months after the completion of Training
Baseline dual-task walking ability
Time frame: Before the start of training
Change from baseline dual-task walking ability upon completion of training
Time frame: Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline dual-task walking ability at 6 months after the completion of training
Time frame: 6 months after the completion of Training
Baseline Tinetti Balance Assessment Tool score
Time frame: Before the start of training
Change from baseline Tinetti Balance Assessment Tool score upon completion of training
Time frame: Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline Tinetti Balance Assessment Tool score at 6 months after the completion of training
Time frame: 6 months after the completion of Training
Baseline Timed 'Up & Go' Tests time
Time frame: Before the start of training
Change from baseline Timed 'Up & Go' Tests time upon completion of training
Time frame: Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline Timed 'Up & Go' Tests time at 6 months after the completion of training
Time frame: 6 months after the completion of Training
Baseline Berg Balance Scale score
Time frame: Before the start of training
Change from baseline Berg Balance Scale score upon completion of training
Time frame: Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline Berg Balance Scale score at 6 months after the completion of training
Time frame: 6 months after the completion of Training
Cognitive function
Time frame: Before the start of training
Baseline fear of falling
Time frame: Before the start of training
Change from baseline fear of falling upon completion of training
Time frame: Upon completion of 12 Training Sessions (4 weeks of training)
Change from baseline fear of falling at 6 months after the completion of training
Time frame: 6 months after the completion of Training
Number of falls between T1 and T2 (post training to 6 months after completion of training)
Time frame: 6 months after the completion of Training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomson Wai Lung WONG principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-task Training, Dual-task Training and Analogy Training in people with Fall and Balance, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomson Wai Lung WONG ((852) 28315258, wongtwl@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline propensity for conscious motor processing (time frame: Before the start of training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.