Investigation of the Relationships Among Balance, Mobility, Pain, Fatigue, and Quality of Life in Individuals With Lyme Disease
NCT07931950, Not yet recruiting, Istanbul Gelisim University
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Investigation of the Relationships Among Balance, Mobility, Pain, Fatigue, and Quality of Life in Individuals With Lyme Disease | ClinicalTrials.gov |
| NCT number | NCT07931950 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 56 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Istanbul Gelisim University | ClinicalTrials.gov |
| Conditions | Lyme Disease | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mini-Mental State Examination (MMSE) | Baseline (Single evaluation at enrollment) | Evaluates five cognitive domains: temporal/spatial orientation, registration, attention and calculation, recall, and language/visuospatial skills. Total score ranges from 0 to 30, with higher scores indicating better cognitive function (24-30: normal, 18-23: mild impairment, 0-17: severe impairment). | ClinicalTrials.gov |
| Primary | 6-Minute Walk Test (6MWT) | Baseline (Single evaluation at enrollment) | Evaluates functional exercise capacity according to American Thoracic Society (ATS) guidelines. Participants walk the maximum distance possible in 6 minutes, with total distance recorded in meters. | ClinicalTrials.gov |
| Primary | Modified Fatigue Impact Scale (MFIS) | Baseline (Single evaluation at enrollment) | Evaluates the impact of fatigue on physical, cognitive, and psychosocial functioning over the past four weeks. Contains 21 items scored on a 5-point Likert scale ranging from 0 (never) to 4 (almost always). Total score ranges from 0 to 84, with higher scores indicating a greater impact of fatigue on daily life and functioning. | ClinicalTrials.gov |
| Primary | Fatigue Severity Scale (FSS) | Baseline (Single evaluation at enrollment) | Evaluates fatigue severity and its impact on activities of daily living over the past week. Consists of 9 items rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The overall score is calculated as the average of the 9 item scores, ranging from 1 to 7, with higher mean scores indicating greater fatigue severity. | ClinicalTrials.gov |
| Primary | Time Up And Go Test (TUG) | Baseline (Single evaluation at enrollment) | Evaluates functional mobility and dynamic balance. Starting from a seated position in a standard-height chair, the participants stands up upon the ''start'' command, walks 3 meters at a normal walking speed, turns around a designated point, walks back, and sits down again. The time required to complete the task is recorded in seconds using a stopwatch, with shorter completion times indicating better functional mobility and dynamic balance. | ClinicalTrials.gov |
| Primary | McGill Pain Questionnaire (MPQ) | Baseline (Single evaluation at enrollment) | Evaluates pain intensity, sensory and affective qualities of pain, and its overall impact on daily life. Participants select word descriptors that best characterize their pain experience, from which the Pain Rating Index (PRI) is calculated. Higher scores indicate greater pain severity and a more significant negative impact of pain on daily life. | ClinicalTrials.gov |
| Primary | Nottingham Health Profile (NHP) | Baseline (Single evaluation at enrollment) | Evaluates health-related quality of life across 38 items covering 6 domains: energy level, pain, emotional reactions, sleep, social isolation, and physical mobility. Participants answer each item with ''yes'' or ''no'' based on their current health status. Scores are calculated separately for each domain ranging from 0 to 100, with no total composite score. Higher scores indicate greater health problems and lower quality of life in that specific domain. | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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 0
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 |
|---|
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)