Cognitive Rehabilitation as a Balance Rehabilitation Strategy in Patients With Parkinson's Disease
NCT04730466, Not applicable, Completed, Universidad Francisco de Vitoria
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Cognitive Rehabilitation as a Balance Rehabilitation Strategy in Patients With Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT04730466 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 46 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Universidad Francisco de Vitoria | ClinicalTrials.gov |
| Conditions | Parkinson Disease | ClinicalTrials.gov |
| Interventions | Neuropsychological rehabilitation | ClinicalTrials.gov |
| First posted | 2021-01-29 | ClinicalTrials.gov |
| Last updated | 2023-04-21 | ClinicalTrials.gov |
Registered outcomes 34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Timed stand up and go test score | From Baseline at 5 weeks | The timed "Up and Go" test measures, in seconds, the time it takes a person to get up from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down again. | ClinicalTrials.gov |
| Primary | Change in Berg Balance scale score | From Baseline at 5 weeks | Consists of 14 items scored on an ordinal scale of 0 to 4 for a total of 56 points (a higher score indicates lower fall risk). Scale is designed to measure changes in functional standing balance over time. This scale measures the balance skills observed during tasks that involve sitting, standing, and changing positions. | ClinicalTrials.gov |
| Primary | Change in Stability limits test: The Biodex Stability Limits (LOS) score | From Baseline at 5 weeks | This test is a challenge for the patient when it comes to moving and exercising control over gravity supported on a base. During each test the patient must change their weight to move the cursor from the center of the target to a new point that will flash on the screen and that will change as fast as the slightest movement or deviation is noticed. This same process will be repeated until another nine objectives are achieved. The test dependent variables provided by the machine are the time (seconds) it takes for the subject to complete the test and the directional control value which is the proportion of the distance travelled by the cursor from the center to each target (based on that 100% is a straight line from the center to the intended target). This means that the greater the distance travelled by the subject, the worse their stability. | ClinicalTrials.gov |
| Primary | Change in Fall risk test score | From Baseline at 5 weeks | During the test, the patient undergoes three attempts of 20 seconds each, beginning with an initial platform mobility setting of 6 and ending with a platform setting of 2 (from least to most mobile), with rest periods ten seconds between each test. The patient stands with feet shoulder-width apart on the midline of the board. At the end of the index test it is calculated according to the degree of instability of the patient with each configuration. Own normative data are applied. | ClinicalTrials.gov |
| Primary | Finger tapping (FT) | Baseline | The FT task has been used as a measure of motor function. In this task, following the Strauss application guidelines, participants are instructed to press the space bar on the keyboard as quickly as possible and repeatedly with the index finger. Five 10-second attempts are made with the dominant hand. The average time between two consecutive hits in the five trials is the dependent variable. | ClinicalTrials.gov |
| Primary | Finger tapping (FT) | At 5 weeks from baseline | The FT task has been used as a measure of motor function. In this task, following the Strauss application guidelines, participants are instructed to press the space bar on the keyboard as quickly as possible and repeatedly with the index finger. Five 10-second attempts are made with the dominant hand. The average time between two consecutive hits in the five trials is the dependent variable. | ClinicalTrials.gov |
| Primary | Simple reaction time (SRT) | Baseline | This task is used as a measure of simple perception and sustained alertness. Participants are instructed to press the left mouse button as fast as possible when the stimulus "+" appears in the center of the screen with a size of 2 cm x 2 cm. The order of appearance is constant for all participants. The task consists of 50 trials that lasted 2-3 minutes.The average time between the stimulus and the response is the dependent variable. | ClinicalTrials.gov |
| Primary | Simple reaction time (SRT) | At 5 weeks from baseline | This task is used as a measure of simple perception and sustained alertness. Participants are instructed to press the left mouse button as fast as possible when the stimulus "+" appears in the center of the screen with a size of 2 cm x 2 cm. The order of appearance is constant for all participants. The task consists of 50 trials that lasted 2-3 minutes.The average time between the stimulus and the response is the dependent variable. | ClinicalTrials.gov |
| Primary | Simple task of attention to sustained response time (SRT-SART) | Baseline | This task helps us to measure the inhibitory response strategy. The participants have to press the left mouse button when the stimulus (digits 1-9) appears in the center of the screen and inhibit the response when it appears as the number "3". The task consists of 168 Go trials and 21 No / Go ; the average duration is 4 minutes. The stimuli vary in size between 12 mm and 29 mm.The average time between the stimulus and the response is the dependent variable. | ClinicalTrials.gov |
| Primary | Simple task of attention to sustained response time (SRT-SART) | At 5 weeks from baseline | This task helps us to measure the inhibitory response strategy. The participants have to press the left mouse button when the stimulus (digits 1-9) appears in the center of the screen and inhibit the response when it appears as the number "3". The task consists of 168 Go trials and 21 No / Go ; the average duration is 4 minutes. The stimuli vary in size between 12 mm and 29 mm.The average time between the stimulus and the response is the dependent variable. | ClinicalTrials.gov |
| Primary | Choice reaction time (CRT) | Baseline | This task was used as a measure of visual perception decision time and is related to the same processes involved in the SRT plus the processing of the uncertainty about which of the stimuli will appear to the continuation, that is, decisional processing. Participants have to press the left mouse button when a square appears in the center of the screen (4 cm x 4 cm) or press the right button when a circle appears. The task consists of 80 tests with a duration of approximately 3 minutes.The average time between the stimulus and the response is the dependent variable. | ClinicalTrials.gov |
| Primary | Choice reaction time (CRT) | At 5 weeks from baseline | This task was used as a measure of visual perception decision time and is related to the same processes involved in the SRT plus the processing of the uncertainty about which of the stimuli will appear to the continuation, that is, decisional processing. Participants have to press the left mouse button when a square appears in the center of the screen (4 cm x 4 cm) or press the right button when a circle appears. The task consists of 80 tests with a duration of approximately 3 minutes.The average time between the stimulus and the response is the dependent variable. | ClinicalTrials.gov |
| Primary | Choice-search reaction time (CRT-Search) | Baseline | This task helps us to measure visual search. Participants have to press the left mouse button when a "Z" appears in a 6-letter sequence or press the right button when it does not appear. Stimuli are classified according to two dimensions: presence/absence of "Z". The task consists of 128 trials that lasted between 5 and 8 minutes. The average time between the stimulus and the response is the dependent variable. | ClinicalTrials.gov |
| Primary | Choice-search reaction time (CRT-Search) | At 5 weeks from baseline | This task helps us to measure visual search. Participants have to press the left mouse button when a "Z" appears in a 6-letter sequence or press the right button when it does not appear. Stimuli are classified according to two dimensions: presence/absence of "Z". The task consists of 128 trials that lasted between 5 and 8 minutes. The average time between the stimulus and the response is the dependent variable. | ClinicalTrials.gov |
| Primary | Stroop test | Baseline | The standardized version applied consists of three DIN-A4 size sheets. Each of which contains 100 elements distributed in five columns of 20 elements. On the first sheet (Stroop-P), the words 'RED', 'GREEN' and 'BLUE' appear, arranged at random and printed in black ink, and the examinee must read them. On the second sheet (Stroop C), all the elements have the same shape ('XXXX') but printed in blue, green, or red ink, and the examinee must say out loud what the color of each one is. On the third sheet (Stroop PC), the first sheet words appear printed in the colors of the second, and the examinee must name the color of the ink with which the word is printed, ignoring the meaning. For each of the sheets, the subject has 45 seconds to say as many items as possible. The number of items and errors are counted for each of the conditions | ClinicalTrials.gov |
| Primary | Stroop test | At 5 weeks from baseline | The standardized version applied consists of three DIN-A4 size sheets. Each of which contains 100 elements distributed in five columns of 20 elements. On the first sheet (Stroop-P), the words 'RED', 'GREEN' and 'BLUE' appear, arranged at random and printed in black ink, and the examinee must read them. On the second sheet (Stroop C), all the elements have the same shape ('XXXX') but printed in blue, green, or red ink, and the examinee must say out loud what the color of each one is. On the third sheet (Stroop PC), the first sheet words appear printed in the colors of the second, and the examinee must name the color of the ink with which the word is printed, ignoring the meaning. For each of the sheets, the subject has 45 seconds to say as many items as possible. The number of items and errors are counted for each of the conditions | ClinicalTrials.gov |
| Primary | The Bells Test | Baseline | This task is a distractor instrument that requires a horizontal visual examination on a sheet of A4 size. The target stimuli are bell figures and are located in a pseudo-random way, organized in seven columns containing five bells each one. The columns are positioned on the sheet as follows: three on the left side, one in the middle, and three on the right side of the paper.The task is completed when the subject stops her activity. The time of completion of the test, the number of hits and omissions is counted. | ClinicalTrials.gov |
| Primary | The Bells Test | At 5 weeks from baseline | This task is a distractor instrument that requires a horizontal visual examination on a sheet of A4 size. The target stimuli are bell figures and are located in a pseudo-random way, organized in seven columns containing five bells each one. The columns are positioned on the sheet as follows: three on the left side, one in the middle, and three on the right side of the paper. The task is completed when the subject stops her activity. The time of completion of the test, the number of hits and omissions is counted. | ClinicalTrials.gov |
| Primary | Trail Making Test | Baseline | It is a measure of combined speed for attention, sequencing, visual and mental searching, as well as motor function. It is made up of two parts: A and B. While part A fundamentally requires visual-perceptual skills, part B requires working memory functioning, as well as skills to change tasks. The task ends when the subject completes the test. The examiner corrects errors during the task, taking the subject to the previous item. The task completion time is measured. | ClinicalTrials.gov |
| Primary | Trail Making Test | At 5 weeks from baseline | It is a measure of combined speed for attention, sequencing, visual and mental searching, as well as motor function. It is made up of two parts: A and B. While part A fundamentally requires visual-perceptual skills, part B requires working memory functioning, as well as skills to change tasks. The task ends when the subject completes the test. The examiner corrects errors during the task, taking the subject to the previous item. The task completion time is measured | 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 8
The papers the trial lists on ClinicalTrials.gov.
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 10
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 |
|---|---|---|
| Cancellation Test | Primary outcome | ConductCognition |
| Choice Reaction Time | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Simple Reaction Time | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Symbol Scan Task | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | 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)