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Clinical Trials/NCT07448961
NCT07448961
Not yet recruiting
Not Applicable

EFFECTS OF SENSORİAL AND COGNİTİVE INDİVİDUALİZED DUAL-TASK TRAİNİNG ON FUNCTİONAL BALANCE, MOBİLİTY, AND DUAL-TASK PERFORMANCE İN OLDER ADULTS: A RANDOMİZED CONTROLLED TRİAL

Sezen Karaborklu Argut1 site in 1 country48 target enrollmentStarted: March 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Sezen Karaborklu Argut
Enrollment
48
Locations
1
Primary Endpoint
Dual-Task Cost (DTC) of Functional Mobility

Overview

Brief Summary

The goal of this clinical trial is to prevent functional decline and improve mobility in healthy older adults aged 65 and over. The main questions it aims to answer are:

What is the effect of individualized dual-task training on functional balance and mobility compared to standard training? Does personalized sensory and cognitive training significantly reduce the dual-task cost during walking tasks? Researchers will compare the Individualized Dual-Task Group to a Standardized Dual-Task Group and a Single-Task Control Group to see if personalized adjustments in sensory and cognitive loads lead to superior improvements in balance, gait speed, and motor-cognitive interference.

Participants will:

Complete an initial assessment of motor and cognitive capacities to determine individual baseline levels.

Participate in a supervised exercise program 3 days a week for 8 weeks, with each session lasting 40-45 minutes.

Perform motor tasks such as walking, obstacle crossing, and balance exercises while simultaneously engaging in cognitive tasks (e.g., counting, verbal fluency).

(For the individualized group) Undergo weekly adjustments in exercise difficulty, including sensory manipulations like surface changes and head movements based on their performance.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

The study is a single-blind trial. While participants and the physical therapist providing the intervention cannot be blinded to the group assignments due to the nature of the exercises, the outcome assessor who performs all baseline and post-intervention measurements will be kept blinded to the group allocations. Data analysis will also be conducted by a researcher blinded to the group codes.

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Aged 65 years and older.
  • Living independently in the community.
  • Ability to walk at least 10 meters without the use of an assistive device (e.g., cane, walker).
  • Cognitively intact, defined as a Montreal Cognitive Assessment (MoCA) score of 24 or higher.
  • Stable medical condition allowing for participation in an 8-week exercise program.
  • Willingness to participate in the study and provide written informed consent.

Exclusion Criteria

  • History of neurological disorders affecting movement or cognition (e.g., Stroke, Parkinson's Disease, Dementia).
  • Acute or chronic orthopedic conditions that severely limit gait or balance (e.g., recent lower limb fracture or major joint replacement within the last 6 months).
  • Severe visual or hearing impairment that prevents following instructions or performing tasks.
  • Uncontrolled cardiovascular or pulmonary disease.
  • Currently participating in another structured exercise or dual-task training program.
  • Inability to commit to the 8-week training schedule.

Arms & Interventions

Individualized Dual-Task Group

Experimental

Participants will receive individualized cognitive-motor dual-task training 3 days a week for 8 weeks. Exercises are adjusted weekly based on individual performance levels.

Intervention: Individualized Dual-Task Training (Behavioral)

Standardized Dual-Task Group

Active Comparator

Participants will receive a standard (fixed-progression) dual-task training program 3 days a week for 8 weeks.

Intervention: Standardized Dual-Task Training (Behavioral)

Single-Task Control Group

Other

Participants will perform single motor tasks (walking or balance exercises only) without simultaneous cognitive tasks for the same duration.

Intervention: Single-Task Motor Training (Behavioral)

Outcomes

Primary Outcomes

Dual-Task Cost (DTC) of Functional Mobility

Time Frame: Baseline and at the end of the 8-week intervention.

Dual-Task Cost (DTC) will be calculated based on the Timed Up and Go (TUG) test performance. DTC represents the percentage change in TUG time during a cognitive-motor dual-task condition (e.g., walking while counting backwards) compared to a single-task condition (walking only). The formula is: DTC = \[(Dual-Task Time - Single-Task Time) / Single-Task Time\] X 100. A higher percentage indicates greater interference and poorer dual-task performance.

Secondary Outcomes

  • Berg Balance Scale (BBS)(Baseline and at the end of the 8-week intervention.)
  • 10-Meter Walk Test (10MWT)(Baseline and at the end of the 8-week intervention.)
  • Falls Efficacy Scale-International (FES-I)(Baseline and at the end of the 8-week intervention.)
  • Montreal Cognitive Assessment (MoCA)(Baseline and at the end of the 8-week intervention.)

Investigators

Sponsor
Sezen Karaborklu Argut
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Sezen Karaborklu Argut

Assistant Professor

Istanbul University - Cerrahpasa

Study Sites (1)

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