Effect of Single-task, Dual-task and Analogy Training During Gait Rehabilitation

Fall Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811782
• Other study ID #: UW17-049
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Balance
• Fall
• Gait Rehabilitation
• Reinvestment Propensity

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