NCT07854093

Brief Summary

Epilepsy is a chronic neurological disorder that can significantly affect a person's physical abilities and daily life due to the condition itself and the side effects of anti-epileptic medications. Individuals with epilepsy often experience fatigue, changes in balance, decreased muscle strength, and reduced mobility, which can restrict their activities of daily living and lead to a decline in their overall quality of life.The primary purpose of this observational study is to comprehensively evaluate the functional status and quality of life in individuals diagnosed with epilepsy. To accurately measure these impacts, the study will compare the physical performance, balance, and fatigue levels of epilepsy patients to a healthy control group.The main question this study attempts to answer is: How do functional mobility, balance, fatigue, and quality of life in individuals with epilepsy differ from those of healthy individuals without the condition?By identifying these physical and functional challenges, researchers aim to better understand the relationship between physical capacity and quality of life in this population. Ultimately, the research findings will guide the future development of targeted physiotherapy and rehabilitation programs designed to improve the functional independence and quality of life for individuals living with epilepsy.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Oct 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026Jan 2027

First Submitted

Initial submission to the registry

September 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 26, 2026

Last Update Submit

October 1, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Upper Extremity Dexterity as Assessed by the 9-Hole Peg Test (9HPT).

    Baseline

  • Objective Dynamic Balance Performance as Assessed by the SportKAT 550 System.

    Baseline

  • Mobility as Assessed by the Timed Up and Go (TUG) Test.

    Baseline.

  • Dynamic Balance and Mobility as Assessed by the 3-meter Backward Walk Test (3mBWT).

    Baseline

  • Lower Extremity Strength and Endurance as Assessed by the 30-Second Chair Stand Test (30-STS).

    Baseline

Secondary Outcomes (4)

  • Quality of Life Score as Assessed by the Quality of Life in Epilepsy-10 (QOLIE-10)

    Baseline.

  • Fatigue Severity as Assessed by the Modified Fatigue Impact Scale (MFIS).

    Baseline.

  • Cognitive Processing Speed as Assessed by the Paced Auditory Serial Addition Test (PASAT-3).

    Baseline.

  • Depression Severity as Assessed by the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E).

    Baseline.

Study Arms (2)

Epilepsy Group

Other: Functional and Quality of Life Assessments

Healthy Control Group

Other: Functional and Quality of Life Assessments

Interventions

Participants will undergo a single-session assessment battery evaluating physical performance, cognition, fatigue, and quality of life. Assessments include: Quality of Life in Epilepsy (QOLIE-10); Modified Fatigue Impact Scale (MFIS); Neurological Disorders Depression Inventory for Epilepsy (NDDI-E); Timed Up and Go (TUG), 3-meter Backward Walk Test (3mBWT), and 30-Second Chair Stand Test (30-STS) for mobility and lower extremity strength; 9-Hole Peg Test (9HPT) for upper extremity dexterity; Paced Auditory Serial Addition Test (PASAT-3) for cognitive processing; and the SportKAT 550® system for objective dynamic balance evaluation. These tests are purely observational (non-therapeutic) and are administered once to both the epilepsy patient group and the healthy control group to compare functional status.

Epilepsy GroupHealthy Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will be selected from adult patients presenting to the neurology outpatient clinic diagnosed with epilepsy, alongside a cohort of healthy volunteers recruited from the local community and hospital staff to serve as the control group.

You may qualify if:

  • Diagnosed with epilepsy by a neurologist (for the patient group),
  • No history of neurological, orthopedic, or vestibular disorders other than epilepsy (for the patient group),
  • Being a healthy individual with no history of chronic medical, neurological, or musculoskeletal conditions (for the control group),
  • Ability to understand and follow verbal instructions,
  • Voluntarily agreed to participate and signed the informed consent form.

You may not qualify if:

  • Presence of any acute musculoskeletal injury, fracture, or severe lower extremity surgery within the past 6 months,
  • History of acute vestibular disorders, vertigo, or balance impairments unrelated to epilepsy,
  • Severe visual or auditory impairments that cannot be corrected and would affect testing performance,
  • Pregnancy or suspected pregnancy,
  • Presence of severe psychiatric disorders or cognitive impairment that prevents participation in functional and questionnaire-based assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Interventions

Functional Status

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Activities of Daily LivingRehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesHealth StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc, Physiotherapist

Study Record Dates

First Submitted

September 26, 2026

First Posted

October 2, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

January 28, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09