Exergame Balance Training for Patients With Mild Cognitive Impairment
NCT04959383, Not applicable, Completed, Riphah International University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Exergame Balance Training for Patients With Mild Cognitive Impairment | ClinicalTrials.gov |
| NCT number | NCT04959383 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Riphah International University | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment | ClinicalTrials.gov |
| Interventions | Low complexity Exergaming group, Moderate complexity Exergaming group, High complexity Exergaming group, Control Group | ClinicalTrials.gov |
| First posted | 2021-07-13 | ClinicalTrials.gov |
| Last updated | 2023-05-30 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Stroop test | 8th weeks | Stroop test measure attention, processing speed, cognitive flexibility, and working memory. This test has good specificity (0.85-0.90). Coloured squares (red, green, blue) are presented in rows first (Stroop A), followed by those colour words typed in black ink (Stroop B), followed by incongruent colour words (Stroop C; in which participants will be asked to name the colour of the ink while ignoring the written word). A ratio will be computed to isolate the executive function component of the task. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Primary | Trails Test | 8th weeks | Trails test is used to assess selective attention, mental flexibility, visual-spatial skills and motor speed. It requires participants to connect numbered circles in ascending order. Color trails-2, requires individuals to connect numbered circles in consecutive order while also alternating the alphabets of the circle. Reliability and validity are adequate. Higher ratios represent a better executive function. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Primary | Digit Span Forward and Backward | 8th weeks | This test measures working memory's number storage capacity. It requires participants to first listen to a list of numbers and repeat them, with the string length increasing to the maximum of their ability. Digit Span Backward, requires repeating a string of numbers in reverse order. Continuing the pattern above to isolate the executive function component, the ratio of the typically smaller sum of correct interference trials on Digit Span Backward, divided by the typically greater sum of correct basic attention trials on Digit Span Forward. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Primary | Montreal Cognitive Assessment | 8th weeks | The MoCA was administered at baseline to characterize the sample as either normative aging or "screened as MCI" The MoCA consists of eight different subtests to assess overall cognitive impairment. Scores below 24 out of 30 were used to categorize MCI. This scale has a good reliability with Cronbach's alpha of 0.905. Its sensitivity is 88% and specificity is 98%. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Primary | Alzheimer's disease Assessment Scale | 8th weeks | Alzheimer's disease Assessment Scale will be used for Immediate and Delayed Recall Participants shows a list of 11 words on cards and they recall as many as they are able immediately and also after a delay interval. The number of errors/omissions comprises the score, so lower scores are better. It is a reliable tool with Cronbach's alpha of 0.83. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Primary | Time Up and Go Test | 8th weeks | The participants rise from sitting, walk 10 feet, turn around and return to the sitting position. The time it takes to complete the task is the score. Lower scores are better. It has a very good validity of 0.857. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Primary | Mini Brief Balance Evaluation Systems | 8th weeks | It is a reliable and valid tool. The mini Balance Evaluation Systems Test (BES Test) is a 14-item clinical balance assessment tool, developed to assess balance across six contexts of postural control: mechanical constraints, limits of stability, postural response to the induced loss of balance, sensory orientation, and gait. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Primary | Smartphone Gait and Balance Application | 8th weeks | The system consists of the following three components: i) a smartphone that has an embedded accelerometer, ii) a belt to house the phone on the lower back, iii) and a smartphone balance application. There are six different tasks that the subject have to perform with the system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and close and standing on a compromised surface with eyes open and close. This app. will calculate mediolateral and anterior-posterior sway during each task. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Primary | Force Plate | 8th weeks | Force Plate is a reliable and valid tool for balance assessment (ICC=0.8). In the force platform test, the mean velocity of the mediolateral (ML) and anterior-posterior (AP) movement of the COP will be calculated (mm/s) according to the displacement of the COP during each second. The mean moment of velocity (m m2/s) will be calculated as the mean of the areas covered by COP movement during each second of the Force Platform. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Primary | Gait Speed Assessment | 8th weeks | Self-selected gait speed (SSGS), fast gait speed (FGS), Cadence are considered to be decreased in patients with MCI. Gait speed will be assessed over 6 meters, and usual- and fast-pace walking mode. The test will be repeated twice with the mean of the two trials will be used for scoring purposes. Participants will be instructed to walk from a standing start at a pace that was normal and comfortable for them or to walk as fast as they could until they reached the end of the marked path. The participants will be asked to stop when their foot contacted the floor at the end of the walking course. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Primary | Electroencephalography | 8th week | An electroencephalography scalp electro-voltage activity (sampling frequency: 128Hz, bandpass hardware filter:1-32Hz) will be used. Delta, theta, beta1 and beta2 will be measured in eye open and closed state. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Primary | Blood Biomarkers | 8th weeks | The blood biomarkers will be assessed. A 5-mL blood sample will be obtained from the patient. The blood samples will be withdrawn for analysis of serum. The blood samples will be centrifuged. Samples will be and stored at - 80 °C for further serum marker assays. Assessment will be done at baseline, after the 4th and 8th week. Blood biomarkers BDNF, IGF-2, VEGF, TNFα, total-tau, amyloid beta-42, a-Synuclein, IL-10, IL1 and IL4 will be measured. | ClinicalTrials.gov |
| Secondary | Voice Recording | 8th weeks | The Voice of all the patients will be recorded. Through voice recording pause length, verbal reaction time, and amount of silence will be assessed. Each participant performed four spoken tasks. The tasks consisted of a counting backward task, a sentence repeating task, an image description task, and a verbal fluency task. Each task will be recorded entirely to extract specific vocal features, including pause length, verbal reaction time, and amount of silence. Assessment will be done at baseline, after the 4th and 8th week. | ClinicalTrials.gov |
| Other | MRI of Brain | 8th weeks | MRI Brain of patients will be carried out to evaluate the Gray matter volume in the hippocampus, prefrontal cortex, dorsolateral prefrontal cortex, the superior temporal sulcus and the anterior cingulate cortex. Assessment will be done at baseline, after the 4th and 8th week. | 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 18
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 11735772 | BACKGROUND | PubMed |
| 12174174 | BACKGROUND | PubMed |
| 12215960 | BACKGROUND | PubMed |
| 18425918 | BACKGROUND | PubMed |
| 18535925 | BACKGROUND | PubMed |
| 20879692 | BACKGROUND | PubMed |
| 21717919 | BACKGROUND | PubMed |
| 22261206 | BACKGROUND | PubMed |
| 23545598 | BACKGROUND | PubMed |
| 25206335 | BACKGROUND | PubMed |
| 25621384 | BACKGROUND | PubMed |
| 27000776 | BACKGROUND | PubMed |
| 27148041 | BACKGROUND | PubMed |
| 27556572 | BACKGROUND | PubMed |
| 27932975 | BACKGROUND | PubMed |
| 28251569 | BACKGROUND | PubMed |
| 28720898 | BACKGROUND | PubMed |
| 41251404 | 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 3
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 |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Fluency | Secondary 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)