StrokeNCT03614195
Effects of Three Types of Dual-task Interventions on Dual-task Walking Performance of Stroke Patients
A study testing MCDTT, MDTT and CDTT in people with Stroke, run by Chang Gung University at 1 site in Taiwan.
Trial summary
The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of three types of dual-task balance interventions on dual-task walking for stroke patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- MCDTT, MDTT and CDTT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Oct 2018to 31 Dec 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) first-ever stroke with onset duration more than 3 months
- (2) able to walk 10 m
- (3) no severe vision, hearing, 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 < 24 on Mini-Mental State Examination)
- severe uncorrected visual deficits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate and Retained Effects of Three Types of Dual-task Interventions on Dual-task Walking Performance of Stroke Patients: Psychometric Study and Randomized Controlled Trial
The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of three types of dual-task balance interventions on dual-task walking for stroke patients.
Read the detailed description
English Synopsis
- Title of Study:
Immediate and retained effects of three types of dual-task interventions on dual-task walking performance of stroke patients: psychometric study and randomized controlled trial
II. Study Objectives:
The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of three types of dual-task balance interventions on dual-task walking for stroke patients. Specifically, we will investigate psychometric properties (i.e. reliability, validity, and responsiveness) of dual-task walking assessments with various levels of difficulty for stroke individuals (Aim 1). The second aim of this study is to compare the immediate and retained effects of combined motor and cognitive dual-task training (MCDTT), motor dual-task training (MDTT), and cognitive dual-task training (CDTT) on dual-task gait and cognitive performance after stroke (Aim 2). The third aim of this study is to elucidate the changed CMI pattern of stroke patients after dual-task interventions (Aim 3).
III. Study Design A metric analysis and comparative efficacy research will be conducted at medical center(s). Sixty ambulatory stroke patients will receive dual-task walking assessments twice at pretreatment with a 1-week interval for test-retest assessment and investigation of the reliability and validity of outcome measures. The primary outcome measure of the six dual-task walking assessments will include two types of walking conditions (walking at preferred speed and fast speed) and simultaneously perform three cognitive tasks (Serial Three Subtractions, Stroop, and Auditory Stroop tasks). These three cognitive tasks represent different domains of cognitive function: working memory and executive function. Concurrent validity will be studied to validate the dual-task walking measures with each other and with the item 14 of the mini-Balance Evaluation Systems test (Mini-BESTest) and dual-task Timed-up-and-Go test (dual-TUG) obtain concurrently for assessing dual-task ability. In addition, we will compare dual-task walking performance between fallers and non-fallers to examine discriminant validity of dual-task assessments.
A comparative efficacy research is a single-blind, randomized controlled trial. Sixty stroke patients will be randomized to MCDTT or MDTT or CDTT. All three groups will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks. The MCDTT group will undertake sitting to standing, standing balance, and treadmill walking training while concurrently perform motor and cognitive tasks. The MDTT and the CDTT groups will train the same set of sitting to standing, standing balance, and walking activities as the MCDTT group while simultaneously performing only motor or cognitive task, respectively. During each session, all participants will receive the instruction of a variable priority to 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 administer three assessments All participants will be examined gait and cognitive performance under single-task (walking only, cognitive tasks only) and dual-task conditions (walking while performing 3 cognitive tasks) at two baselines, post intervention, and 1-month follow-up. The primary outcome measure of gait and cognition is gait speed and composite score of accuracy and reaction time of the cognitive tasks under single- and dual-task conditions. The secondary outcome measures will be the Berg Balance Scale, Mini-BESTest, dual-TUG, Functional Gait Assessment, Activity-specific Balance Confidence Scale, Chair Stand Test, Stroke Impact Scale, and Patient Global Impression of Change. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up among the groups.
Number of Planned Patients: 60 stroke patients Duration of the Study: 2018/08/01～2021/07/31
- Conditions
- Stroke
- Being tested
- MCDTT, MDTT, CDTT
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCDTTDevice
The MCDTT group will undertake sitting to standing, standing balance, and treadmill walking training while concurrently perform motor and cognitive tasks.
MDTTDevice
The MDTT group will train the same set of sitting to standing, standing balance, and walking activities as the MCDTT group while simultaneously performing only motor task.
CDTTDevice
The CDTT group will train the same set of sitting to standing, standing balance, and walking activities as the MCDTT group while simultaneously performing only cognitive task.
| Study group | Role | What they receive |
|---|---|---|
| MCDTT | Experimental | The MCDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks. Receives: Device: MCDTT |
| MDTT | Active comparator | The MDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks. Receives: Device: MDTT |
| CDTT | Active comparator | The CDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks. Receives: Device: CDTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 gait parameter is gait speed (cm/s) under dual-task walking conditions using the 10 Meter Walking Test.
Measured: 10 minutes
composite score
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
Secondary outcomes (8)
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
Mini-Balance Evaluation Systems Test (Mini-BESTest).
The Mini-BESTest consists of 14 items and.includes four subscales: anticipatory postural adjustmentsl, reactive postural control, sensory orientation, and dynamic gait. Each item is rated on a three-point ordinal scale (0 = severe, 1=moderate, and 2 = normal), with a maximum score of 28 points.
Measured: 10 minutes
Timed Up and Go Test (TUG)
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 m, turn, walk back, and sit down again. The score is the time to complete the test measured using a stopwatch. 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: 2 minutes
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 fear of falling and self-reported confidence when performing 15 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: 2 minutes
Chair Stand Test (CS).
The Chair Stand Test measures lower extremity muscular strength.87 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. Timed five-chair stand (TCS) is the time measured using a stopwatch to complete five times of standing from sitting
Measured: 2 minutes
Muscle Strength of Lower-Extremity.
Handheld dynamometers (MicroFET2, Hoggan Health Industries Inc, West Jordan, Utah; Jamar ® Plus+ hand dynamometer, Patterson Medical® Sammons Preston®) will be used to measure the maximum isometric strength of tibialis anterior and grip strength (averaged over three attempts and left and right limbs) using a standard protocol with high test-retest reliability.
Measured: 10 minutes
Patient Global Impression of Change Scale (PGIC).
Participants will be evaluated 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 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start24 Oct 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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
- 54 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614195
- Sponsor's protocol ID
- 201701988A3
- Status last verified
- Jul 2022
- First submitted
- 31 Jul 2018
- Last updated
- 2 Aug 2022
- 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 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Retained Effects of Three Types of Dual-task Interventions on Dual-task Walking Performance of Stroke Patients: Psychometric Study and Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03614195
- Acronym / sponsor ID
- 201701988A3
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 3 Aug 2018 (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 psychometric properties of dual-task walking assessments and compare effects of three types of dual-task balance interventions on dual-task walking for stroke patients.
Detailed description
English Synopsis
- Title of Study:
Immediate and retained effects of three types of dual-task interventions on dual-task walking performance of stroke patients: psychometric study and randomized controlled trial
II. Study Objectives:
The objective of this study is to investigate psychometric properties of dual-task walking assessments and compare effects of three types of dual-task balance interventions on dual-task walking for stroke patients. Specifically, we will investigate psychometric properties (i.e. reliability, validity, and responsiveness) of dual-task walking assessments with various levels of difficulty for stroke individuals (Aim 1). The second aim of this study is to compare the immediate and retained effects of combined motor and cognitive dual-task training (MCDTT), motor dual-task training (MDTT), and cognitive dual-task training (CDTT) on dual-task gait and cognitive performance after stroke (Aim 2). The third aim of this study is to elucidate the changed CMI pattern of stroke patients after dual-task interventions (Aim 3).
III. Study Design A metric analysis and comparative efficacy research will be conducted at medical center(s). Sixty ambulatory stroke patients will receive dual-task walking assessments twice at pretreatment with a 1-week interval for test-retest assessment and investigation of the reliability and validity of outcome measures. The primary outcome measure of the six dual-task walking assessments will include two types of walking conditions (walking at preferred speed and fast speed) and simultaneously perform three cognitive tasks (Serial Three Subtractions, Stroop, and Auditory Stroop tasks). These three cognitive tasks represent different domains of cognitive function: working memory and executive function. Concurrent validity will be studied to validate the dual-task walking measures with each other and with the item 14 of the mini-Balance Evaluation Systems test (Mini-BESTest) and dual-task Timed-up-and-Go test (dual-TUG) obtain concurrently for assessing dual-task ability. In addition, we will compare dual-task walking performance between fallers and non-fallers to examine discriminant validity of dual-task assessments.
A comparative efficacy research is a single-blind, randomized controlled trial. Sixty stroke patients will be randomized to MCDTT or MDTT or CDTT. All three groups will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks. The MCDTT group will undertake sitting to standing, standing balance, and treadmill walking training while concurrently perform motor and cognitive tasks. The MDTT and the CDTT groups will train the same set of sitting to standing, standing balance, and walking activities as the MCDTT group while simultaneously performing only motor or cognitive task, respectively. During each session, all participants will receive the instruction of a variable priority to 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 administer three assessments All participants will be examined gait and cognitive performance under single-task (walking only, cognitive tasks only) and dual-task conditions (walking while performing 3 cognitive tasks) at two baselines, post intervention, and 1-month follow-up. The primary outcome measure of gait and cognition is gait speed and composite score of accuracy and reaction time of the cognitive tasks under single- and dual-task conditions. The secondary outcome measures will be the Berg Balance Scale, Mini-BESTest, dual-TUG, Functional Gait Assessment, Activity-specific Balance Confidence Scale, Chair Stand Test, Stroke Impact Scale, and Patient Global Impression of Change. Repeated measure ANOVA will be used to compare measurements at baseline, after training, and follow-up among the groups.
Number of Planned Patients: 60 stroke patients Duration of the Study: 2018/08/01～2021/07/31
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MCDTT | Experimental | Device: MCDTTThe MCDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks. |
| MDTT | Active comparator | Device: MDTTThe MDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks. |
| CDTT | Active comparator | Device: CDTTThe CDTT group will receive dual-task interventions at progressively increasing task difficulty 3 times a week for 4 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) first-ever stroke with onset duration more than 3 months
- (2) able to walk 10 m
- (3) no severe vision, hearing, and language problems.
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 < 24 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 |
|---|---|---|
| MCDTTThe MCDTT group will undertake sitting to standing, standing balance, and treadmill walking training while concurrently perform motor and cognitive tasks. | Device | MCDTT |
| MDTTThe MDTT group will train the same set of sitting to standing, standing balance, and walking activities as the MCDTT group while simultaneously performing only motor task. | Device | MDTT |
| CDTTThe CDTT group will train the same set of sitting to standing, standing balance, and walking activities as the MCDTT group while simultaneously performing only cognitive task. | Device | CDTT |
Primary outcome
gait speed
Time frame: 10 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 gait parameter is gait speed (cm/s) under dual-task walking conditions using the 10 Meter Walking Test.
composite score
Time frame: 10 minutes
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.
8 secondary outcomes
Berg Balance Scale (BBS).
Time frame: 5-10 minutes
Mini-Balance Evaluation Systems Test (Mini-BESTest).
Time frame: 10 minutes
Timed Up and Go Test (TUG)
Time frame: 2 minutes
Functional Gait Assessment (FGA).
Time frame: 10 minutes
Activity-specific Balance Confidence Scale (ABC).
Time frame: 2 minutes
Chair Stand Test (CS).
Time frame: 2 minutes
Muscle Strength of Lower-Extremity.
Time frame: 10 minutes
Patient Global Impression of Change Scale (PGIC).
Time frame: 1 minutes
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 2 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCDTT, MDTT and CDTT in people with Stroke, 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 3 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 2 Aug 2022. 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?
gait speed (time frame: 10 minutes). The study lists 2 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 2 Aug 2022.