NCT07028333

Brief Summary

The purpose of this study is to investigate the effects of motor-motor and motor-cognitive dual-task exercises applied to children with mild mental retardation on their functional mobility, balance, cognitive function, and quality of life.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

June 11, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

Dual-Task ExerciseMotor FunctionCognitive FunctionRehabilitationmental retardationBalancephysiotherapy and Rehabilitation

Outcome Measures

Primary Outcomes (4)

  • Berg Balance Scale (BBS)

    The Pediatric Balance Scale (PBS), used to assess functional balance in children during daily activities, is a highly reliable measurement tool. It is an adapted version of the Berg Balance Scale specifically designed for children. The scale consists of 14 items evaluating functional movements such as standing up, picking up an object from the floor, transferring, balancing on one foot, and sitting. Each item is scored on a scale from 0 to 4, with 4 indicating the ability to perform the task independently. The maximum score is 56. Scores between 0-20 indicate poor balance, 21-40 indicate acceptable balance, and 41-56 indicate good balance.

    6 weeks

  • Timed Up and Go Test

    Description: The Timed Up and Go Test (TUG) is used to assess functional mobility by measuring walking speed, postural control, and balance. The test involves standing up from a standard-height chair without armrests, walking a distance of 3 meters, turning around, walking back to the chair, and sitting down. Participants perform one practice trial followed by three test trials, with the average time recorded in seconds. A shorter duration indicates better functional mobility and balance.

    6 weeks

  • Tandem Walking Test

    Description: The Tandem Walking Test is used to assess dynamic balance, a function primarily controlled by the cerebellum. Participants are instructed to walk 10 steps in a straight line, placing the heel of one foot directly in front of the toes of the other foot with each step, minimizing the base of support. The time taken to complete the 10 steps is recorded, and a shorter time indicates better dynamic balance.

    6 weeks

  • Stroop Test

    Description: The Stroop Test is a neuropsychological assessment that measures cognitive processing speed, selective attention, response inhibition, and cognitive flexibility-functions associated with the frontal lobe. It includes four cards, each containing six rows with four items per row. Participants are required to name the color of the ink used rather than the word itself, evaluating their ability to inhibit habitual responses and adapt to cognitive interference.

    6 weeks

Secondary Outcomes (1)

  • Pediatric Quality of Life Inventory (PedsQL)

    6 weeks

Study Arms (3)

motor-motor dual task exercise group

EXPERIMENTAL

While this group performs walking and balance exercises accompanied by a physiotherapist, it will perform motor tasks.

Behavioral: Motor-Motor Dual Task Exercise Group

Motor-Cognitive Dual Task Exercise Group

EXPERIMENTAL

While this group performs walking and balance exercises accompanied by a physiotherapist, it will perform cognitive tasks.

Behavioral: Motor-Cognitive Dual Task Exercise Group

Control Group

PLACEBO COMPARATOR

Standard walking and balance exercises will be given to the control group at home and followed by parents.

Behavioral: Control Group

Interventions

Participants in this group will perform motor tasks (such as ball handling, throwing, holding) accompanied by physiotherapist. Exercises will last about 40 minutes, 2 days a week, 6 weeks.

motor-motor dual task exercise group

This group will also do walking and balance exercises with the physiotherapist, while simultaneously doing cognitive tasks (rhythmic counting, saying color names, finding words, etc.). The exercises will last approximately 40 minutes, 2 days a week, for 6 weeks.

Motor-Cognitive Dual Task Exercise Group
Control GroupBEHAVIORAL

Standard walking and balance exercises will be given to the control group at home and followed by parents. Exercises will last about 40 minutes, 2 days a week, 6 weeks.

Control Group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Obtaining parental consent
  • Having an Intelligence Quotient between 51-70
  • Having an educational diagnosis of mild mental retardation
  • Being between the ages of 8-12
  • Ability to understand Turkish instructions
  • Ability to follow commands during the exercise program
  • No additional disabilities that would prevent participation in the program

You may not qualify if:

  • Having a metabolic or systemic disease
  • Engaging in regular physical exercise
  • Having visual or hearing impairments
  • Presence of any condition that would interfere with compliance to assessment parameters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Intellectual Disability

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Melike N AKGÖĞ, MScStudent

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melike N AKGÖĞ, MScStudent

CONTACT

Yıldız ANALAY AKBABA, AssocProfDr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
his study is a three-arm, randomized controlled interventional trial involving children aged 8-12 with mild mental retardation. Participants will be randomly assigned to one of three groups: Motor-Motor Dual Task Exercise, Motor-Cognitive Dual Task Exercise, or Control. The Motor-Motor group will perform walking and balance exercises combined with motor tasks under physiotherapist supervision. The Motor-Cognitive group will perform the same physical exercises combined with cognitive tasks. The Control group will follow standard walking and balance exercises at home, monitored by parents. Interventions will last six weeks, conducted twice a week for about 40 minutes per session. Assessments of motor function, cognitive performance, and quality of life will be conducted before and after the intervention by blinded evaluators. Data will be analyzed to compare group outcomes and determine the effects of dual-task exercises on motor and cognitive functions in children with mild mental ret
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a three-arm, randomized controlled trial involving children aged 8-12 with mild mental retardation. Participants will be randomly assigned to one of three groups: Motor-Motor Dual Task Exercise, Motor-Cognitive Dual Task Exercise, or Control. The Motor-Motor group will perform walking and balance exercises combined with motor tasks under physiotherapist supervision. The Motor-Cognitive group will perform the same physical exercises combined with cognitive tasks. The Control group will follow standard walking and balance exercises at home, monitored by parents. Interventions will last six weeks, conducted twice a week for about 40 minutes per session. Assessments of motor function, cognitive performance, and quality of life will be conducted before and after the intervention by blinded evaluators. Data will be analyzed to compare group outcomes and determine the effects of dual-task exercises on motor and cognitive functions in children with mild mental re
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Student

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 19, 2025

Study Start

November 15, 2024

Primary Completion

July 5, 2025

Study Completion

November 10, 2025

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) will not be shared due to privacy concerns and the sensitive nature of the data involving children with mild mental retardation. Additionally, sharing may be restricted to protect participant confidentiality and comply with ethical approvals. Data may be made available upon reasonable request and after necessary approvals to qualified researchers.

Locations