- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04419753
The Role of Attention Focus Walking Training in Older Adults.
Examining the Role of External and Internal Attention Focus Walking Training on Conscious Motor Processing During Rehabilitation by Older Adults at Risk of Falling in Hong Kong: A Randomized Controlled Trial.
This study aims to examine the effect of external, internal and no attention focus walking training during gait rehabilitation on real-time conscious motor processing (reinvestment), balance, walking ability and fear of falling by older adults at risk of falling in Hong Kong.
One-hundred and eight older adults will be recruited from elderly community centers in Hong Kong. Participants will be randomly assigned into 3 groups (i.e., No Attention Focus Walking Group (NAFWG; active control group, n=36), an External Attention Focus Walking Group (EAFWG, n = 36) or an Internal Attention Focus Walking Group (IAFWG, n = 36)). Participants in different groups will have training sessions (about 45 minutes each) three times per week for 4 weeks in a group of 6 participants. A total of 12 sessions will be completed by each participant.
All training sessions will be conducted by experienced registered physiotherapists in Hong Kong and a research assistant with experience in exercise training for older adults. 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 levels of difficulties in a 40-meter walkway with different instructions in different walking groups (20 minutes) and cool down (5 minutes). For the walking training (20 minutes), all participants will be invited to conduct walking training on a walking field with an area of 25 meter square and a total walking distance of about 40 meters for each walking trial from cone 1 to 9. Two screens that connected with a laptop computer will be positioned 1 meter beside the walking field. Both screens will be projected different digits from 0 to 9 randomly in the speed of 2 seconds per digit. Participants in the NAFWG, EAFWG, and IAFWG will receive different instructions during walking training.
Each participant will complete 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 (T0), a structural questionnaire will be used to ask for demographics, medical history, detailed history of fall incident, social history and social economic status of all participants. A battery of assessments will be conducted to assess physical and cognitive abilities of the participants in all assessment sessions (T0, T1, & T2). Walking ability will be assessed by the 10 meters comfortable and fast walking speed (Bohannon, 1997). Functional balance and gait assessment will be done by the Tinetti Balance Assessment Tool (Tinetti, 1986), the Berg Balance Scale (BBS) (Berg et al., 1989) and the Timed 'Up & Go' Tests (TU&G) (Podsiadlo & Richardson, 1991). Cognitive function will be evaluated by the Chinese version Mini-Mental State Examination (MMSE-C) (Folstein et al., 1975; Chiu et al., 1994). The Chinese version of the Fall Efficacy Scale International (FES-I (Ch)) (Kwan, Tsang, Close & Lord, 2013) will be completed to assess the fear of falling. The Chinese version Movement Specific Reinvestment Scale (MSRS-C) (Masters et al., 2005; Wong et al., 2015a; Wong et al., 2015b) will be administered to examine the conscious motor processing propensity (i.e., movement specific reinvestment). The alpha2 EEG coherence between T3 (verbal-analytical region of the brain) and the Fz (motor planning region of the brain) (i.e., T3-Fz EEG coherence) of all participants when walking at the 6-meter level-ground walkway (three walking trials) will be determined to identify the real-time conscious motor processing propensity (Zhu et al., 2011; Ellmers et al., 2016; Chu & Wong, 2019). All participants will be equipped with EEG electrodes before the start of the three walking trials. EEG activity will be received using a wireless EEG device (Brainquiry PET 4.0, Brainquiry, The Netherlands) and will be recorded using the real-time biophysical data acquisition software (BioExplorer 1.5, CyberEvolution, US). Previous research has demonstrated that alpha2 (10-12Hz) T3-Fz EEG coherence is sensitive at detecting within-subject changes in real-time conscious motor processing propensity during a postural sway task (Ellmers et al., 2016). T4-Fz EEG coherence will be utilized to identify whether the changes in the alpha2 T3-Fz EEG coherence will be due to global activation of the brain. The EEG electrodes are non-invasive and will not be used in any diagnostic purpose.
All participants will 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 structural calendar. The number of falls within the 6-month follow-up period will then be collected.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomson Wai Lung WONG, PhD
- Phone Number: (852)27666717
- Email: thomson.wong@polyu.edu.hk
Study Locations
-
-
-
Hung Hom, Hong Kong
- The Hong Kong Polytechnic University
-
Contact:
- Thomson Wai Lung WONG, PhD
- Phone Number: (852)27666717
- Email: thomson.wong@polyu.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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) total score of equal or more than 24;
- Able to walk independently indoor for at least 40 meters continuously with comfortable pace;
- 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.
Exclusion Criteria:
- Any potential participant who cannot meet the inclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: No Attention Focus Walking Group (NAFWG)
In each training session, the NAFWG 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 levels of difficulties in a 40-meter walkway without attention focus instruction (20 minutes) and cool down (5 minutes).
|
Use different attention focus instructions or no attention focus instruction during walking training in older adults to examine whether the attention focus instructions can ameliorate conscious motor processing and optimize rehabilitation outcome measurements.
|
Experimental: External Attention Focus Walking Group (EAFWG)
In each training session, the EAFWG 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 levels of difficulties in a 40-meter walkway with external attention focus instructions (20 minutes) and cool down (5 minutes).
|
Use different attention focus instructions or no attention focus instruction during walking training in older adults to examine whether the attention focus instructions can ameliorate conscious motor processing and optimize rehabilitation outcome measurements.
|
Experimental: Internal Attention Focus Walking Group (IAFWG)
In each training session, the IAFWG 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 levels of difficulties in a 40-meter walkway with internal attention focus instructions (20 minutes) and cool down (5 minutes).
|
Use different attention focus instructions or no attention focus instruction during walking training in older adults to examine whether the attention focus instructions can ameliorate conscious motor processing and optimize rehabilitation outcome measurements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Real-time conscious motor processing propensity at 1 month (post-training) and 7 months (6 months post-training)
Time Frame: At Day 0, Month 1, and Month 7
|
will be measured by the Alpha 2 T3-Fz EEG coherence (Zhu et al., 2011; Ellmers et al., 2016; Chu & Wong, 2019).
|
At Day 0, Month 1, and Month 7
|
Change from Baseline Functional balance and gait ability at 1 month (post-training) and 7 months (6 months post-training)
Time Frame: At Day 0, Month 1, and Month 7
|
will be assessed by the Tinetti Balance Assessment Tool (Tinetti, 1986).
|
At Day 0, Month 1, and Month 7
|
Change from Baseline Functional balance ability at 1 month (post-training) and 7 months (6 months post-training)
Time Frame: At Day 0, Month 1, and Month 7
|
will be assessed by the Berg Balance Scale (BBS) (Berg et al., 1989).
|
At Day 0, Month 1, and Month 7
|
Change from Baseline Functional gait ability at 1 month (post-training) and 7 months (6 months post-training)
Time Frame: At Day 0, Month 1, and Month 7
|
will be assessed by the Timed 'Up & Go' Tests (TU&G) (Podsiadlo & Richardson, 1991).
|
At Day 0, Month 1, and Month 7
|
Change from Baseline Walking ability at 1 month (post-training) and 7 months (6 months post-training)
Time Frame: At Day 0, Month 1, and Month 7
|
will be assessed by the 10 meters comfortable and fast walking speed (Bohannon, 1997).
|
At Day 0, Month 1, and Month 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Conscious motor processing propensity (i.e., movement specific reinvestment) at 1 month (post-training) and 7 months (6 months post-training)
Time Frame: At Day 0, Month 1, and Month 7
|
will be assessed by the Chinese version Movement Specific Reinvestment Scale (MSRS-C) (Masters et al., 2005; Wong et al., 2015a; Wong et al., 2015b).
|
At Day 0, Month 1, and Month 7
|
Change from Baseline Fear of falling at 1 month (post-training) and 7 months (6 months post-training)
Time Frame: At Day 0, Month 1, and Month 7
|
will be assessed by the Chinese version of the Fall Efficacy Scale International (FES-I (Ch)) (Kwan, Tsang, Close & Lord, 2013).
|
At Day 0, Month 1, and Month 7
|
Cognitive function
Time Frame: At Day 0
|
will be evaluated by the Cantonese version of the Mini-Mental State Examination (MMSE-C) (Chiu, Lee, Chung & Kwong, 1994).
|
At Day 0
|
Change from Baseline Visuo-spatial involvement in movement control at 1 month (post-training) and 7 months (6 months post-training)
Time Frame: At Day 0, Month 1, and Month 7
|
will be assessed by the Alpha 2 T4-Fz EEG coherence (Zhu et al., 2011; Ellmers et al., 2016; Chu & Wong, 2019).
|
At Day 0, Month 1, and Month 7
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomson Wai Lung WONG, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UW 19-099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rehabilitation
-
Westfälische Wilhelms-Universität MünsterNational Paralympic Committee Germany (NPCG)CompletedCardiac Rehabilitation | Feasibility Studies | Organization and Administration | Rehabilitation ExerciseGermany
-
Asan Medical CenterRecruitingPulmonary Rehabilitation | Cardiac RehabilitationKorea, Republic of
-
University Hospital, ToursCompletedPulmonary Rehabilitation | Respiratory RehabilitationFrance
-
Suleyman Demirel UniversityCompleted
-
Orton Orthopaedic HospitalCompleted
-
Richard Watson, PTCompletedMedial Patellar Femoral Ligament Reconstruction Rehabilitation | Anterior Cruciate Ligament Reconstruction RehabilitationUnited States
-
Cairo UniversityRecruiting
-
Bruyere Research InstituteBruyere Academic Medical OrganizationRecruiting
-
National Cheng Kung UniversityRecruiting
-
University College AbsalonUniversity of Southern Denmark; Arla Foods; Danish Council for Independent Research and other collaboratorsCompleted
Clinical Trials on attention focus walking training
-
Klaus WidhalmCompleted
-
Western Carolina UniversityTexas Woman's University; Mission Health System, Asheville, NCRecruiting
-
Federal University of Health Science of Porto AlegreCompletedMuscle Weakness | Muscle Weakness Condition | Neck; AnomalyBrazil
-
St. Pölten University of Applied SciencesKarl Landsteiner University of Health Sciences; Danube University Krems; Orthopedic...UnknownKnee Osteoarthritis | Physiotherapy | Lower Extremity BiomechanicsAustria
-
Southern California Institute for Research and...California State University, Long Beach; California State University, Dominguez...UnknownTranstibial AmputationUnited States
-
University of North Carolina, CharlotteArthritis FoundationRecruitingOsteo Arthritis Knee | Anterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearUnited States
-
University of North Carolina, CharlotteRecruitingAnterior Cruciate Ligament InjuriesUnited States
-
National Taiwan University HospitalUnknownAttention on Posture | Attention on SuprapostureTaiwan
-
University of North Carolina, CharlotteRecruitingAnkle Injuries | Ankle Inversion SprainUnited States
-
Western Carolina UniversityEnrolling by invitation