Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:54 AM
Study NCT ID:
NCT07488650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Children With Specific Learning Disabilities and Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1: Individual education program + Perceptual-motor exercise training\n\nGroup 2: Individual education program + Virtual reality-based exercise training\n\nGroup 3: Individual education program (SLD support education program: speech-language therapy, academic education with special education content, etc.) (control group)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motor Skill Level', 'timeFrame': 'Baseline (pre-exercise) and 8 weeks (post-exercise)', 'description': "The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition - Brief Form (BOT-2 BF) will be used to assess children's motor proficiency skill levels. The test duration is approximately 15-20 minutes. The subtests and items of the BOT 2-BF are (1) Fine Motor Precision: Completing the inside of a star and drawing a line along a path; (2) Fine Motor Integration: Copying interlocking circles and a diamond shape; (3) Manuel Dexterity: Threading blocks onto a string; (4) Bilateral Coordination: Touching the tip of the nose with the index finger (eyes closed) and drawing a square with the thumb and index finger; (5) Balance: Walking on a line from heel to toe; (6) Speed and Agility: Hopping on one foot; (7) Upper-Limb Coordination: Catching a thrown ball (with one hand) and dribbling; and (8) Strength: Full push-ups and knee push-ups. For each task, item scores are converted into processed scores using the Likert scale for that task. The Likert score values differ for each task."}, {'measure': 'Functional Balance', 'timeFrame': 'Baseline (pre-exercise) and 8 weeks (post-exercise)', 'description': "Children's functional balance assessment will be evaluated using the Pediatric Balance Scale (PBS). The PBS was developed as a balance measurement for school-aged children with mild to moderate motor impairment by modifying the Berg Balance Scale. No special equipment is required for the test. The test takes less than 20 minutes to complete. The scale consists of 14 items, including sitting balance, standing balance, transfers (rising from sitting and standing), stepping, reaching forward and downward, turning, and stepping onto and off a raised surface. Each item is rated on a scale of 0 to 4. A score of 0 indicates inability to perform the task, while a score of 4 indicates the ability to perform the task without any difficulty. The maximum total score is 56. The Turkish validity and reliability study was conducted by Erden et al.."}, {'measure': 'Single-Leg Stance Test', 'timeFrame': 'Baseline (pre-exercise) and 8 weeks (post-exercise)', 'description': 'The Single-Leg Stance Test assesses static balance. For the Single-Leg Stance Test, children will be instructed to maintain balance on their non-dominant leg with their eyes open. During this time, the other leg will be held with the knee at 90° flexion and the hip at 0° flexion. The time elapsed before the opposite foot touches the ground or until the test position is broken will be measured in seconds using a stopwatch. This test will be performed twice, and the highest score will be recorded.'}, {'measure': 'Flamingo Balance Test', 'timeFrame': 'Baseline (pre-exercise) and 8 weeks (post-exercise)', 'description': 'This test will be used to assess static balance. A 50 cm long, 4 cm high, and 3 cm wide wooden beam and a stopwatch will be used when performing the flamingo balance test. Children will be asked to stand upright in the middle of the long line, with one foot on the ground and the other knee bent, holding the free foot with the same hand, for 1 minute after removing their shoes. A trial run will be conducted before the test so that children can understand the test. The child will be helped into position on the wooden beam, and the test will begin with the command "start" when the child is ready. If balance is lost, in other words, if the foot touches the ground, the time will be stopped, the child will return to the test position, and the stopwatch will resume from where it left off. The child will receive points for each attempt made during the 1 minute. If balance is lost more than 15 times within 30 seconds during the test, or if the child falls, the test will be stopped.'}, {'measure': 'Timed Up and Go Test', 'timeFrame': 'Baseline (pre-exercise) and 8 weeks (post-exercise)', 'description': 'The Timed Up and Go Test (TUG) evaluates functional mobility and the balance required to transition from a sitting position to a standing position, walk, turn, and return to a sitting position. First, the test will be demonstrated to the participants, and then they will be given one trial run to understand it. Three trials are recommended for each TUG assessment. For the single-task, children will be instructed to stand up from a standard armless chair, walk 3 meters in a straight line at their normal comfortable pace, turn 180°, return to the chair, and sit down. For the dual motor task, participants will perform the modified TUG test while holding an empty tray with both hands. For the dual cognitive task, children will perform the modified TUG test while verbally counting backward from a given number in increments of 1. Children will be instructed to focus on the backward counting task as quickly and accurately as possible. The result is recorded in seconds.'}, {'measure': 'Four Square Step Test', 'timeFrame': 'Baseline (pre-exercise) and 8 weeks (post-exercise)', 'description': 'This test evaluates dynamic balance. For the test, Four canes, each 90 cm in length, will be placed on the ground at a 90° angle to form a plus sign ("+") configuration. A four-square area will be created around the "+" sign, and the squares will be numbered from 1 to 4. A trial run will be conducted to ensure that the children understand the task. To administer the test, each child will stand inside square 1, facing square 2. The child will then be asked to step clockwise into the squares in the order "2, 3, 4, 1" (forward, right, back, and finally left), and then counterclockwise in the order "4, 3, 2, 1". Time measurement will start when the first foot touches the first square. The child will continue to look forward as much as possible throughout the sequence, and both feet must touch the square before moving on to the next square. The completion time of the test will be recorded in seconds. Two trials will be performed by the children, and the fastest time will be recorded.'}, {'measure': 'Proprioception', 'timeFrame': 'Baseline (pre-exercise) and 8 weeks (post-exercise)', 'description': 'The Joint Position Sense (JPS) test will be administered for proprioception assessment. A Baseline brand digital goniometer will be used for this assessment. Lower extremity proprioception will be evaluated, with separate measurements taken for the hip, knee, and ankle joints. Measurements will be taken for both the right and left sides. The child will be positioned appropriately, the joint will be passively brought to the target angle, and 10 seconds will be waited for the child to perceive the position. The child will then be returned to the starting position and asked to find the target angle with their eyes closed. The difference between the target angle and the angle created by the child during the test will be determined as the error score. Three measurements will be taken for the target angle, and the arithmetic mean of the differences will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Participation', 'timeFrame': 'Baseline (pre-exercise) and 8 weeks (post-exercise)', 'description': "Children's participation and environmental factors that may influence participation will be assessed using the Participation and Environment Measurement for Children and Youth (PEM-CY). PEM-CY is a questionnaire completed by parents to assess the participation and environmental factors of children and adolescents aged 5-17 in different settings (home, school, and community). For each setting, the participation items consist of various activities typically performed in that setting. For each type of activity in each setting, parents are asked (a) how often their children participate in the activities (never = 0-every day = 7); (b) how involved their children are during participation (very little = 1-very much = 5); and (c) whether they would like to see any changes in their children's participation (yes/no). Parents are then asked whether certain environmental characteristics facilitate or hinder their children's participation in activities or whether resources are adequate/appropriate"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Specific Learning Disability', 'virtual reality', 'perceptual-motor exercise', 'motor skills', 'proprioception', 'balance', 'participation'], 'conditions': ['Specific Learning Disability']}, 'descriptionModule': {'briefSummary': 'Specific learning disabilities (SLD) are neurodevelopmental disorders seen in children with normal or above-average intelligence (IQ\\> 85), no significant brain damage or sensory impairment, who experience difficulties in reading, writing, speaking, or performing functions. Visual-motor control, dynamic balance, and bilateral coordination are among the most prominent motor skill deficits in children with SLD. Accordingly, the aim of this study is to examine the effects of perceptual motor exercises and virtual reality-based exercises on the motor skills, balance function, proprioception, and participation of children with SLD. In the randomized controlled trial, children aged 7-10 years with SLD will be randomly allocated into three groups: a perceptual-motor exercise group, a virtual reality-based exercise group, and a control group that will continue their usual individual education program without additional exercise intervention. The exercise program will be carried out twice a week for 45 minutes over an 8-week period. Assessments will be conducted before and after the intervention. Motor skill level will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition - Brief Form, functional balance using the Pediatric Balance Scale, static balance using the Single-Leg Stance Test and the Flamingo Balance Test, dynamic balance using the Timed Up and Go Test and the Four Square Step Test, proprioception using the Joint Position Sense Test, and participation using the Participation and Environment Measurement for Children and Youth. The effect of the exercise interventions on these parameters will be compared between the intervention groups and the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 7 and 10\n* Having a diagnosis of SLD according to DSM-V diagnostic criteria\n* Regular attendance at a special education and rehabilitation center and an individual support education program\n* Children and their families who agree to participate in the study\n\nExclusion Criteria:\n\n* Having an additional diagnosis such as autism spectrum disorder, developmental coordination disorder, intellectual disability, any psychiatric disorder precluding exercise\n* Having mechanical hearing and/or visual impairment\n* Having any health problem that prevents exercise\n* Currently receiving or having received a rehabilitation program such as physical therapy or occupational therapy\n* Children and their families who do not agree to participate in the study'}, 'identificationModule': {'nctId': 'NCT07488650', 'briefTitle': 'Children With Specific Learning Disabilities and Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Effect of Perceptual-Motor Exercise and Virtual Reality-Based Exercise on Motor Skills, Balance, Proprioception and Participation in Children With Specific Learning Disabilities: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2026-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Group 1', 'description': 'Group 1 will participate in a 45-minute perceptual-motor exercise program twice a week for 8 weeks.', 'interventionNames': ['Behavioral: Perceptual-Motor Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise Group 2', 'description': 'Group 2 will participate in a 45-minute virtual reality-based exercise program twice a week for 8 weeks.', 'interventionNames': ['Behavioral: Virtual Reality-Based Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Group 3 (control group)', 'description': 'Group 3 will only participate in their usual individual education program (SLD support education program). They will not be included in any exercise program.'}], 'interventions': [{'name': 'Perceptual-Motor Exercise', 'type': 'BEHAVIORAL', 'description': 'The exercise program will consist of a 10-minute warm-up, 25 minutes of targeted perceptual-motor exercises, and a 10-minute cool-down period. The program for the perceptual-motor exercise group will be developed using previous studies in this field derived from the Jack Capon protocol. The program will include, for example, basic movement activities (walking forward-backward and zigzag, jumping forward-backward and crosswise, jumping forward-backward, etc.), ball-rope-hoop activities (throwing and catching a ball with the hand, bouncing a ball with one hand, kicking a ball selected from among balls of different colors, jumping rope, jumping over and under the rope, passing through hoops on the ground, spinning the hoop around the waist, etc.), balance beam and vaulting box activities (walking on a flat or narrow beam, standing on one foot, jumping on and off the box, moving between boxes, etc.).', 'armGroupLabels': ['Exercise Group 1']}, {'name': 'Virtual Reality-Based Exercise', 'type': 'BEHAVIORAL', 'description': 'The X box 360 Kinect (Microsoft) will be used for the virtual reality-based exercise. Children will be given a 10-minute tutorial session before the first session to explain how to play the games and the rules they must follow. Feedback will be provided to children as needed. The virtual reality-based exercise group will consist of a 5-minute warm-up and 40 minutes of virtual reality games. The cool-down period will include a game involving less intense activity. Game content: Kinect Adventures game (20,000 Leaks, Space Pop, River Rush, Reflex Ridge, etc.) Kinect Sports I (Short-distance running, Hurdle Jump, Long Jump, etc.)', 'armGroupLabels': ['Exercise Group 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Duygu Korkem', 'investigatorAffiliation': 'Hacettepe University'}}}}