StrokeNCT03234998
Comparative Efficacy of Two Different Dual-task Balance Interventions
A study testing motor-cognitive dual-task training and cognitive dual-task training in people with Stroke and Healthy Older Adults, run by Chang Gung University at 1 site in Taiwan.
Trial summary
The objective of this study is to investigate the effects of two different dual-task balance interventions for stroke patients and older adults. Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Healthy Older Adults
- What is being tested?
- motor-cognitive dual-task training and cognitive dual-task training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Aug 2017to 25 Feb 2019
- 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 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- first-ever stroke with onset duration more than 3 months
- able to walk 10 m
- no severe vision, hearing, and language problems
- more than 65 years old
- able to walk 10 m
- no neurological or musculoskeletal diagnosis
- no severe vision, hearing, cognition, and language problems.
Who cannot join
- orthopedic and other neurological disorders that affect walking
- other treatments that could influence the effects of the interventions (e.g., recent Botulin toxin treatment of the lower extremity)
- moderate or severe cognitive impairments (score <21 on Mini-Mental State Examination)
- severe uncorrected visual deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Two Different Dual-task Balance Interventions on Balance, Gait, and Cognitive Performance Under Single- and Dual-task Conditions in Stroke Patients and Older Adults
The objective of this study is to investigate the effects of two different dual-task balance interventions for stroke patients and older adults.
Read the detailed description
English Synopsis
- Title of Study:
Comparative efficacy of two different dual-task balance interventions on balance, gait, and cognitive performance under single- and dual-task conditions in stroke patients and older adults
II. Study Objectives:
The objective of this study is to investigate the effects of two different dual-task balance interventions for stroke patients and older adults. Specifically, the investigators will compare the immediate and retention effects of motor and cognitive dual-task balance training [MCDT] and cognitive dual-task balance training [CDT]) on balance, gait, and cognition under single- and dual-task conditions in individuals with stroke (Aim 1) and elderly people (Aim 2). The third aim of this study is to elucidate the mechanisms underlying changes in balance, gait, and cognitive performance of stroke patients and older adults after MCDC and CDT (Aim 3).
III. Study Design A prospective randomized control trial will be conducted at medical centers in this study. Fifty stroke patients and 48 elderly people will be randomly allocated to either MCDT or CDT group. Both groups will receive 12 hours of training over 4 weeks at progressively increasing task difficulty (60 minutes per session, three times a week, for four weeks). The CDT group will undertake dual-task balance training and concurrently perform only cognitive tasks with instruction of a variable priority. The MCDT group will train the same set of balance/gait activities as the CDT while simultaneously performing motor and cognitive tasks with instruction of a variable priority. During each session, all participants practice shifting attention between tasks by spending half of the training attention focus on the balance task, and half focus on the secondary cognitive or motor tasks. A blinded assessor will conduct three assessments at baseline, post intervention, and 1-month follow-up. At baseline, all participants will be examined balance, gait, and cognitive performance under single-task (standing, walking, cognitive tasks only) and dual-task conditions (standing/walking while performing cognitive tasks). Six cognitive tasks (simple reaction time task, serial three subtractions task, Stroop task, auditory Stroop task, spatial memory task, and choice reaction time task) will be used to examine dual-task performance because these tasks represent different domains of cognitive function (information processing speed, working memory, and executive function). The primary outcome measure of balance, gait, and cognition will be the sway index, gait speed, and composite score of accuracy and reaction time under single- and dual-task conditions. Secondary outcome measures will include: Berg Balance Scale, Timed Up and Go test under single- and dual-task conditions, Functional Gait Assessment, Activity-specific Balance Confidence Scale, Chair Stand Test, and Patient Global Impression of Change. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up between the groups.
Number of Planned Patients: 50 stroke patients and 48 elderly people Duration of the Study: 2017/08/01～2020/07/31
- Conditions
- Stroke, Healthy Older Adults
- Being tested
- motor-cognitive dual-task training, cognitive dual-task training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor-cognitive dual-task trainingDevice
Also called MCDT
Participants in the motor-cognitive dual-task training group will will receive an individually-progressed program of dual-task balance/gait training aimed at improving standing balance, sit-to-stand, and walking abilities under motor-cognitive dual-task conditions.
cognitive dual-task trainingDevice
Also called CDT
Participants in the cognitive dual-task training group will perform only cognitive tasks (verbal fluency tasks, calculation tasks, and visual discrimination tasks) concurrently with the balance/gait tasks.
| Study group | Role | What they receive |
|---|---|---|
| motor-cognitive dual-task training | Experimental | Participants in the motor-cognitive dual-task training group will participate in 12-session programs administered for 60 minutes each session, 3 times per week for 4 weeks. Receives: Device: motor-cognitive dual-task training |
| cognitive dual-task training | Active comparator | Participants in the cognitive dual-task training group will also participate in a 12-session program conducted 60 minutes per session, 3 days a week, for a total of 4 weeks. Receives: Device: cognitive dual-task training |
What is being measured
The primary outcome is the main question the study is designed to answer.
sway index
Sway index is the standard deviation of the sway angle. The higher the sway index the more unsteady the person was during the test.
Measured: 10 minutes
gait speed
Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch. The primary outcome measure will be gait speed (cm/s) under single- and dual-task conditions.
Measured: 5 minutes
composite score
Participants will be asked to perform six different cognitive tasks while sitting, standing, and walking. The order of six cognitive tasks will be counterbalanced, but will be equal for the single- and dual-task conditions. The six cognitive tasks are selected based upon the different domains of cognitive tasks commonly used in previous dual-task studies. For all the cognitive tasks, we will calculate a composite score for cognitive-task performance by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs in the overall dual-task effect.
Measured: 10 minutes
cognitive-motor interference (CMI)
The effect of dual-tasking on both standing/walking and cognitive parameters will be assessed by comparing any change in performance of balance/gait and cognitive measures between single- and dual-task conditions. We will calculate DTE for gait speed and composite score using following formula: [(Dual-task - Single-task)/ Single-task *100] and for sway index using formula: [(Single-task - Dual-task)/ Single-task *100]. Negative cost (higher cost) indicates poor performance on dual-task conditions compared with single-task conditions.
Measured: 20 minutes
Secondary outcomes (6)
Berg Balance Scale (BBS)
The BBS is a 14-item scale quantitatively assesses both static and dynamic balance with psychometrically sound measure of balance impairment after stroke.The items are scored from 0 to 4, with a score of 0 representing independent item completion. Scores of the BBS range from 0 to 56, with higher scores suggest better balance.
Measured: 5-10 minutes
Timed Up and Go Test
The TUG test will be used as an index of dynamic balance of the elderly and stroke patients. At the signal, participants stand up, walk 3 meters, turn, walk back, and sit down again. The score is the mean time measured using a stopwatch if two trials to complete the test. The TUG test will be administered under the single-task (preferred speed and maximum fast) and dual-task conditions (tray carrying and counting backward by 3s). In dual-task condition, participants will be asked to perform the TUG test while carrying a tray with glasses (dual-TUG manual) or counting backward by 3s (dual-TUG cognition). The instruction for dual-TUG tests is to walk with your comfortable speed and concurrently perform a secondary task (carry the tray in front of you with both hands without dropping glasses on the tray or counting backward by 3s).
Measured: 2minutes
Functional Gait Assessment (FGA)
The FGA is comprised of 10-item that contains 7 of 8 items (except walking around obstacles) from the Dynamic Gait Index and 3 additional tasks, including walking with a narrow base of support, walking with the eyes closed, and walking backward. Subjects' performance of each test item was rated on a 4-point scale (0-3), with the total score ranging between 0 and 30.
Measured: 10 minutes
Activity-specific Balance Confidence Scale (ABC)
The ABC will be used to determine self-reported confidence when performing 16 different daily activities, such as walking around the house, walking up and down stairs, and walking on slippery floors. A confidence rating scale ranges from 0% to 100%, with 0% indicating no confidence, and 100% indicating full confidence.
Measured: 3 minutes
Chair Stand Test.
The Chair Stand Test measures lower extremity muscular strength.The participants will be instructed to stand from a seated on the chair position as much as possible for 30 seconds. The total number of stands was counted in 30 seconds.
Measured: 1 minute
Patient Global Impression of Change Scale (PGIC)
Overall patient perception of MCDT or CDT will be evaluated using a Patient Global Impression of Change Scale (PGIC) regarding the participants' perception with the change in balance and gait related to the intervention. The PGIC is a transition scale that is a single question asking the patients to rate their balance/gait now, as compared with how it was prior to before beginning treatment on a scale from 1 (very much better ) to 7 (very much worse).
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start25 Aug 2017
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Ling Chuang, Chang Gung University
- Investigators
- Li-Ling Chuang, PhD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234998
- Sponsor's protocol ID
- 1612190002
- Status last verified
- Mar 2020
- First submitted
- 27 Jul 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Two Different Dual-task Balance Interventions on Balance, Gait, and Cognitive Performance Under Single- and Dual-task Conditions in Stroke Patients and Older Adults
- ClinicalTrials.gov ID
- NCT03234998
- Acronym / sponsor ID
- 1612190002
- Conditions
- Stroke, Healthy Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 1 Aug 2017 (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 objective of this study is to investigate the effects of two different dual-task balance interventions for stroke patients and older adults.
Detailed description
English Synopsis
- Title of Study:
Comparative efficacy of two different dual-task balance interventions on balance, gait, and cognitive performance under single- and dual-task conditions in stroke patients and older adults
II. Study Objectives:
The objective of this study is to investigate the effects of two different dual-task balance interventions for stroke patients and older adults. Specifically, the investigators will compare the immediate and retention effects of motor and cognitive dual-task balance training [MCDT] and cognitive dual-task balance training [CDT]) on balance, gait, and cognition under single- and dual-task conditions in individuals with stroke (Aim 1) and elderly people (Aim 2). The third aim of this study is to elucidate the mechanisms underlying changes in balance, gait, and cognitive performance of stroke patients and older adults after MCDC and CDT (Aim 3).
III. Study Design A prospective randomized control trial will be conducted at medical centers in this study. Fifty stroke patients and 48 elderly people will be randomly allocated to either MCDT or CDT group. Both groups will receive 12 hours of training over 4 weeks at progressively increasing task difficulty (60 minutes per session, three times a week, for four weeks). The CDT group will undertake dual-task balance training and concurrently perform only cognitive tasks with instruction of a variable priority. The MCDT group will train the same set of balance/gait activities as the CDT while simultaneously performing motor and cognitive tasks with instruction of a variable priority. During each session, all participants practice shifting attention between tasks by spending half of the training attention focus on the balance task, and half focus on the secondary cognitive or motor tasks. A blinded assessor will conduct three assessments at baseline, post intervention, and 1-month follow-up. At baseline, all participants will be examined balance, gait, and cognitive performance under single-task (standing, walking, cognitive tasks only) and dual-task conditions (standing/walking while performing cognitive tasks). Six cognitive tasks (simple reaction time task, serial three subtractions task, Stroop task, auditory Stroop task, spatial memory task, and choice reaction time task) will be used to examine dual-task performance because these tasks represent different domains of cognitive function (information processing speed, working memory, and executive function). The primary outcome measure of balance, gait, and cognition will be the sway index, gait speed, and composite score of accuracy and reaction time under single- and dual-task conditions. Secondary outcome measures will include: Berg Balance Scale, Timed Up and Go test under single- and dual-task conditions, Functional Gait Assessment, Activity-specific Balance Confidence Scale, Chair Stand Test, and Patient Global Impression of Change. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up between the groups.
Number of Planned Patients: 50 stroke patients and 48 elderly people Duration of the Study: 2017/08/01～2020/07/31
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| motor-cognitive dual-task training | Experimental | Device: motor-cognitive dual-task trainingParticipants in the motor-cognitive dual-task training group will participate in 12-session programs administered for 60 minutes each session, 3 times per week for 4 weeks. |
| cognitive dual-task training | Active comparator | Device: cognitive dual-task trainingParticipants in the cognitive dual-task training group will also participate in a 12-session program conducted 60 minutes per session, 3 days a week, for a total of 4 weeks. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- first-ever stroke with onset duration more than 3 months
- able to walk 10 m
- no severe vision, hearing, and language problems
- more than 65 years old
- able to walk 10 m
Key exclusion criteria (4 listed)
- orthopedic and other neurological disorders that affect walking
- other treatments that could influence the effects of the interventions (e.g., recent Botulin toxin treatment of the lower extremity)
- moderate or severe cognitive impairments (score <21 on Mini-Mental State Examination)
- severe uncorrected visual deficits
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 |
|---|---|---|
| motor-cognitive dual-task trainingAlso: MCDTParticipants in the motor-cognitive dual-task training group will will receive an individually-progressed program of dual-task balance/gait training aimed at improving standing balance, sit-to-stand, and walking abilities under motor-cognitive dual-task conditions. | Device | motor-cognitive dual-task training |
| cognitive dual-task trainingAlso: CDTParticipants in the cognitive dual-task training group will perform only cognitive tasks (verbal fluency tasks, calculation tasks, and visual discrimination tasks) concurrently with the balance/gait tasks. | Device | cognitive dual-task training |
Primary outcome
sway index
Time frame: 10 minutes
Sway index is the standard deviation of the sway angle. The higher the sway index the more unsteady the person was during the test.
gait speed
Time frame: 5 minutes
Participants will walk 10m at their preferred speed and at fast speed. A 12-meter walkway will be used for walking testing. In order to allow the subjects to have enough distance to accelerate and decelerate, only the time taken to walk the middle 10 meters will be recorded by a stopwatch. The primary outcome measure will be gait speed (cm/s) under single- and dual-task conditions.
composite score
Time frame: 10 minutes
Participants will be asked to perform six different cognitive tasks while sitting, standing, and walking. The order of six cognitive tasks will be counterbalanced, but will be equal for the single- and dual-task conditions. The six cognitive tasks are selected based upon the different domains of cognitive tasks commonly used in previous dual-task studies. For all the cognitive tasks, we will calculate a composite score for cognitive-task performance by dividing the accuracy (% correct responses) with the reaction time of correct answers (milliseconds), which accounts for speed-accuracy tradeoffs in the overall dual-task effect.
cognitive-motor interference (CMI)
Time frame: 20 minutes
The effect of dual-tasking on both standing/walking and cognitive parameters will be assessed by comparing any change in performance of balance/gait and cognitive measures between single- and dual-task conditions. We will calculate DTE for gait speed and composite score using following formula: [(Dual-task - Single-task)/ Single-task *100] and for sway index using formula: [(Single-task - Dual-task)/ Single-task *100]. Negative cost (higher cost) indicates poor performance on dual-task conditions compared with single-task conditions.
6 secondary outcomes
Berg Balance Scale (BBS)
Time frame: 5-10 minutes
Timed Up and Go Test
Time frame: 2minutes
Functional Gait Assessment (FGA)
Time frame: 10 minutes
Activity-specific Balance Confidence Scale (ABC)
Time frame: 3 minutes
Chair Stand Test.
Time frame: 1 minute
Patient Global Impression of Change Scale (PGIC)
Time frame: 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Li-Ling Chuang, PhD principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor-cognitive dual-task training and cognitive dual-task training in people with Stroke and Healthy Older Adults, run by Chang Gung University at 1 site in Taiwan.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 19 Oct 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sway index (time frame: 10 minutes). The study lists 4 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 19 Oct 2020.