Comparative Effectiveness Research of Dual-task and Single-task Balance Training in People With Stroke
NCT02686515, Not applicable, Completed, Chang Gung University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Comparative Effectiveness Research of Dual-task and Single-task Balance Training in People With Stroke | ClinicalTrials.gov |
| NCT number | NCT02686515 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 44 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Chang Gung University | ClinicalTrials.gov |
| Conditions | Stroke | ClinicalTrials.gov |
| Interventions | single-task balance training, dual-task balance training | ClinicalTrials.gov |
| First posted | 2016-02-19 | ClinicalTrials.gov |
| Last updated | 2024-02-07 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Sway index | 10 minutes | Participants will stand on a platform (Biosway Balance System, Biodex Medical Systems, Inc., NY, USA) and perform modified clinical test of sensory integration of balance test (mCTSIB) for 20 seconds in each of 4 conditions (Eyes open/closed, Firm/Foam surface). The instruction of this test is to maintain your center of balance and try not to move. The primary outcome of balance ability is sway index. The sway index is really the standard deviation of the sway angle. The higher the sway index the more unsteady the participant was during the test. | ClinicalTrials.gov |
| Primary | Gait speed | 5 minutes | Participants will walk 10m at their preferred speed and at fast speed. Participants will be instructed to begin walking about 1 m before stepping on the walkway and to keep walking about 1 m beyond the walkway to exclude acceleration and deceleration phases on the walkway. The time to complete the middle 10 m will be recorded using a stopwatch. The primary outcome measure will be gait speed under single- and dual-task conditions. | ClinicalTrials.gov |
| Primary | Composite score = Accuracy/Reaction time | 10 minutes | Participants will be asked to perform three different cognitive tasks while sitting, standing, walking at preferred speed, and walking at fast speed. The order of three cognitive tasks will be counterbalanced, but will be equal for the single- and dual-task conditions.These three cognitive tasks are simple reaction time task, counting backward by 3s, and Stroop task.To account for possible speed-accuracy trade-off, a composite score will be calculated by dividing accuracy (% correct responses) by verbal reaction time (milliseconds) will be used to indicate cognitive performance. | ClinicalTrials.gov |
| Primary | Cognitive-Motor Interference (CMI) | 30 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 CMI for each of the balance/gait outcome measures and 3 cognitive measures using following formula: \[(Single-task - Dual-task)/Single-task \*100\]. Higher cost indicates poor performance on dual-task conditions. | ClinicalTrials.gov |
| Secondary | Berg Balance Scale (BBS) | 5-10 minutes | The BBS will be used to quantify balance performance under single-task conditions on tasks such as standing with eyes closed, standing with feet together, and picking up an object from the floor. Scores of the BBS range from 0 to 56, with higher scores suggest better balance. | ClinicalTrials.gov |
| Secondary | Timed Up and Go test (TUG) | 2 minutes | The TUG test will be used as an index of mobility of the elderly and stroke patients.66 The TUG test measures the time it takes a participant to rise from a chair, walk 3 m, and then return to the chair and sit down. The TUG test will be administered under the single-task and dual-task conditions. In dual-task condition, participants will be asked to perform the TUG test while carrying a tray with glasses (dual-TUG). The instruction for dual-TUG test is to walk with your comfortable speed and carry this tray in front of you with both hands without dropping glasses on the tray. | ClinicalTrials.gov |
| Secondary | Activity-specific balance confidence scale (ABC) | 3 minutes | 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. | ClinicalTrials.gov |
| Secondary | Fugl-Meyer Assessment (FMA) | 5 minutes | The FMA motor subscale will be used to measure voluntary lower limb motor function in stroke participants with a 3-point ordinal scale on each item (0-cannot perform, 1-performs partially, 2-performs fully) (maximum: 34). | ClinicalTrials.gov |
| Secondary | Functional Independent Measurement (FIM) | 5 minutes | The FIM will be used to assess daily function. The level of participants' disability indicates the burden of caring for them and items are scored on the basis of how much assistance is required for participants to carry out activities of daily living. The FIM consists of 18 items grouped into 6 subscales: self-care, sphincter control, transfer, locomotion, communication, and social cognition ability. Each item is rated from 1 to 7 (max. score 126) based on the required level of assistance to perform the tasks. | ClinicalTrials.gov |
| Secondary | Nottingham Extended Activities of Daily Living Scale (NEADL) | 5 minutes | The NEADL was developed to assess the level of independence in instrumental activity of daily living of stroke patients after hospital discharge. It has four subscales (mobility, domestic, leisure and kitchen) and consists of 22 items scored on the basis of the requirement for help in performing the activity described. The subjects will be asked what they actually did but not what they could do to assess their real daily performance and their level of independence in daily life rather than their capabilities. Items will be scored from 0 to 3 points and summed to provide an overall score, with higher scores indicative of better activities participation. | ClinicalTrials.gov |
| Secondary | Stroke Impact Scale Version 3.0 (SIS 3.0) | 10 minutes | Health-related quality of life will be measured using the SIS 3.0, which is specific to the stroke population. The SIS 3.0 contains 59 items measuring 8 domains (i.e., strength, hand function, Activities of Daily Living/Instrumental Activities of Daily Living \[ADL/IADL\], mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week. Aggregate scores, ranges from 0 to 100, are generated for each domain. | ClinicalTrials.gov |
| Secondary | Fall rate | 2 minutes | Participants will be followed prospectively over a period of three months using a falls diary to document their falls event. To assure higher accuracy, participants will also receive monthly follow-up telephone calls to remind them to update their falls diary and the number of falls participants has been fallen in the previous month will be recorded. Participants will be categorized as multiple fallers (≧2 falls), single fallers (1 falls), and non-fallers (no falls) according to information from the falls diaries and monthly follow-up telephone calls. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 38885066 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Simple Reaction Time | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)