- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07554144
The Effect of Body Percussion Training on Neuromotor Performance, Attention, and Functionality in Adolescents With Mild Intellectual Disability
The Effect of Body Percussion Training on Neuromotor Performance, Attention, and Functionality in Adolescents With Mild Intellectual Disability: A Randomized Controlled Study
The aim of this randomized controlled trial is to investigate the effects of group-based rhythm-based body percussion training on neuromotor performance, attention, and functionality in adolescents with mild intellectual disability.
The study will be conducted in individuals aged 14-18 years with mild intellectual disability using a two-arm, parallel-group, evaluator-blind design. Participants will be assigned to experimental and control groups using a simple randomization method.
The experimental group will receive structured body percussion training twice a week for 45 minutes over 8 weeks. This training consists of rhythmic patterns including clapping, knee tapping, chest tapping, finger snapping, and foot tapping, and will be presented as a progressively advancing program with metronome accompaniment.
The control group will receive passive music listening without intervention for the same duration and frequency.
Participants will be evaluated at two time points: before and after the intervention. Evaluation tools include: The tests cover neuromotor performance with the Minnesota Hand Skills Test and the Four Square Step Test, rhythm coordination with the Metronome Synchronization Test, attention with the Stroop Test, and functionality with the World Health Organization Disability Assessment Chart 2.0.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being an adolescent aged 14-19 attending high school (e.g., special education high school)
- Having been diagnosed with mild intellectual disability (IQ range according to relevant psychological assessment)
- Having communication skills sufficient to understand simple commands and adapt to work
- Being able to perform basic daily living activities (toilet hygiene and management, bladder/bowel management, eating, bathing, personal hygiene, dressing, functional mobility, etc.) independently or with minimal support, regardless of the level of disability
- Signing an informed consent form with family consent and/or legal guardian consent
Exclusion Criteria:
- Painful musculoskeletal/orthopedic (rheumatic, etc.) problems that may prevent physical participation in rhythm-based body percussion training, restrict movement during training, and cause pain
- Cardiovascular problems (arrhythmia, hypertension, etc.) that may prevent participants from attending training during the study period
- Diagnosis of moderate or severe intellectual disability
- Presence of additional diagnoses such as autism spectrum disorder, cerebral palsy, or developmental coordination disorder
- Participation in a systematic physical therapy program other than rhythm or motor training
- Conditions affecting motor performance due to medical or surgical treatment (within the last 6 months)
- Severe auditory and visual deficits that hinder communication and the ability to imitate movements
- Individuals who cannot attend regularly during the study period due to personal or family reasons
- The family/adolescent's desire to withdraw from the study of their own accord
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rhythm-based body percussion training group
The body percussion training to be applied to the experimental group consists of specific movement combinations and rhythmic patterns.
The basic striking areas used in the training are defined as hand, chest, knee, and foot.
Foot movements are divided into two sub-regions to obtain different sound tones: heel strike ("dum") and toe strike ("tek").
All movements are supported by visual symbols to make it easier for participants to follow the rhythmic patterns.
|
Body percussion training consists of specific movement combinations and rhythmic patterns.
The basic striking areas used in training are defined as the hand, chest, knee, and foot.
Foot movements are divided into two sub-regions to produce different sound tones: heel strike ("dum") and toe strike ("tek").
All movements are supported by visual symbols to make it easier for participants to follow the rhythmic patterns.
|
|
Active Comparator: Control group
The intervention to be applied to the control group will be applied at a similar frequency and intensity to the experimental group.
The control group will be played music used for body percussion training in the experimental group at specific intervals for 45 minutes to maintain attention (3 rounds of 15 minutes listening followed by 1-2 minutes of break).
Participants will be asked to listen to the music in a comfortable seated position without any motor participation.
They will be given simple instructions during the session not to talk, not to think about other things (just listen to the music), to sit quietly, and not to fall asleep (sit quietly, listen to the music, etc.).
Distracting stimuli in the environment will be reduced.
The music volume will be adjusted to a level that does not disturb all participants.
Participants in the control group will be asked not to participate in any structured music listening activities (choir, concert, etc.) during the session.
|
The music used for body percussion training will be played at specific intervals for 45 minutes to maintain attention (in 3 rounds: 15 minutes listening followed by a 1-2 minute break).
The music volume will be adjusted so as not to disturb any of the participants.
Metronome adjustments, which are important in progression, will be applied similarly to the experimental group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minnesota Hand Dexterity Test
Time Frame: before the intervention
|
This is a test used to assess upper extremity function and coordination.
Participants sit in a seated position with a table in front of them and are asked to move, place, or rotate small, standard-sized, disc-shaped objects across the table to varying distances within the shortest possible time.
The placement test can be performed separately for the dominant and non-dominant sides.
Participants are asked to pick up 40 cylindrical objects one by one using only one hand and place them in the appropriate hole.
The rotation test requires coordinated work of both hands.
Individuals are asked to pick up a disc-shaped object with one hand, lift it, rotate it so that the other side is facing the floor, pass it to the other hand, and then place the object in the corresponding hole with the other hand.
For individuals with mild intellectual disabilities, step-by-step guidance will be provided as needed to manage complexity during the test.
|
before the intervention
|
|
Minnesota Hand Dexterity Test
Time Frame: after 8 weeks of training
|
This is a test used to assess upper extremity function and coordination.
Participants sit in a seated position with a table in front of them and are asked to move, place, or rotate small, standard-sized, disc-shaped objects across the table to varying distances within the shortest possible time.
The placement test can be performed separately for the dominant and non-dominant sides.
Participants are asked to pick up 40 cylindrical objects one by one using only one hand and place them in the appropriate hole.
The rotation test requires coordinated work of both hands.
Individuals are asked to pick up a disc-shaped object with one hand, lift it, rotate it so that the other side is facing the floor, pass it to the other hand, and then place the object in the corresponding hole with the other hand.
For individuals with mild intellectual disabilities, step-by-step guidance will be provided as needed to manage complexity during the test.
|
after 8 weeks of training
|
|
The Four Square Step Test
Time Frame: before the intervention
|
The test assesses dynamic balance through multi-directional stepping.
The test area will be prepared by placing four 90 cm rods on the floor to create four squares.
The test requires stepping forward, backward, and sideways over the obstacles in a specific sequence.
Participants attempt to complete the test by stepping between the squares in the required sequence as quickly as possible; they must avoid touching the rods and follow the correct step sequence.
The timer starts when the first foot touches the first square and ends when the last foot touches the fourth square.
For individuals with mild intellectual disabilities, colored numbers (1 = green, 2 = blue, 3 = black, 4 = yellow) will be placed at the corners of the squares, and a red circle indicating forward-facing position will be placed on the wall.
|
before the intervention
|
|
The Four Square Step Test
Time Frame: after 8 weeks of training
|
The test assesses dynamic balance through multi-directional stepping.
The test area will be prepared by placing four 90 cm rods on the floor to create four squares.
The test requires stepping forward, backward, and sideways over the obstacles in a specific sequence.
Participants attempt to complete the test by stepping between the squares in the required sequence as quickly as possible; they must avoid touching the rods and follow the correct step sequence.
The timer starts when the first foot touches the first square and ends when the last foot touches the fourth square.
For individuals with mild intellectual disabilities, colored numbers (1 = green, 2 = blue, 3 = black, 4 = yellow) will be placed at the corners of the squares, and a red circle indicating forward-facing position will be placed on the wall.
|
after 8 weeks of training
|
|
Metronome Synchronization Test:
Time Frame: before the intervention
|
This is a test that assesses sensorimotor synchronization skills using a clapping task accompanied by a metronome.
Participants are asked to clap in sync with the metronome rhythm, and the accuracy of the synchronization (asynchrony (timing error), variability (rhythm variation), accuracy) is evaluated using an observational scoring system.
The scoring is as follows: 0-Unable to follow the rhythm, 1-Frequent rhythm errors, 2-Moderate compliance, 3-Significant compliance with the rhythm, 4-Complete synchronization.
|
before the intervention
|
|
Metronome Synchronization Test:
Time Frame: after 8 weeks of training
|
This is a test that assesses sensorimotor synchronization skills using a clapping task accompanied by a metronome.
Participants are asked to clap in sync with the metronome rhythm, and the accuracy of the synchronization (asynchrony (timing error), variability (rhythm variation), accuracy) is evaluated using an observational scoring system.
The scoring is as follows: 0-Unable to follow the rhythm, 1-Frequent rhythm errors, 2-Moderate compliance, 3-Significant compliance with the rhythm, 4-Complete synchronization.
|
after 8 weeks of training
|
|
Stroop Test
Time Frame: before the intervention
|
This is a neuropsychological test widely used for both experimental and clinical purposes.
It assesses the ability to inhibit cognitive interference when the processing of one stimulus feature affects the simultaneous processing of another feature of the same stimulus.
Participants must perform a less automatic task and inhibit interference from a more automatic task.
This difficulty in inhibiting the more automatic process is called the Stroop effect.
In addition to measuring the ability to inhibit cognitive interference, the test is also used to measure other cognitive functions such as attention, processing speed, cognitive flexibility, and working memory.
The number of errors and the time taken to complete the task will be recorded.
|
before the intervention
|
|
Stroop Test
Time Frame: after 8 weeks of training
|
This is a neuropsychological test widely used for both experimental and clinical purposes.
It assesses the ability to inhibit cognitive interference when the processing of one stimulus feature affects the simultaneous processing of another feature of the same stimulus.
Participants must perform a less automatic task and inhibit interference from a more automatic task.
This difficulty in inhibiting the more automatic process is called the Stroop effect.
In addition to measuring the ability to inhibit cognitive interference, the test is also used to measure other cognitive functions such as attention, processing speed, cognitive flexibility, and working memory.
The number of errors and the time taken to complete the task will be recorded.
|
after 8 weeks of training
|
|
The World Health Organization Disability Assessment Scale 2.0
Time Frame: before the intervention
|
This tool attempts to determine how much difficulty an individual experiences while performing certain activities and consists of 6 areas that include activities considered important in many cultures (17).
These are grouped under the headings: 1) Cognition, 2) Movement, 3) Self-care, 4) Interaction, 5) Life activities, 6) Social participation.
In each item of the scale, the individual's difficulty in certain areas of functioning in the last 30 days should be scored on a 5-point Likert scale as none, some, quite, much, or extremely.
In our study, a 12-item short form will be used, suitable for our population of mildly intellectually disabled individuals.
In addition, a 12-item proxy form will be requested from parents or special education teachers for those who are able to complete it.
|
before the intervention
|
|
The World Health Organization Disability Assessment Scale 2.0
Time Frame: after 8 weeks of training
|
This tool attempts to determine how much difficulty an individual experiences while performing certain activities and consists of 6 areas that include activities considered important in many cultures (17).
These are grouped under the headings: 1) Cognition, 2) Movement, 3) Self-care, 4) Interaction, 5) Life activities, 6) Social participation.
In each item of the scale, the individual's difficulty in certain areas of functioning in the last 30 days should be scored on a 5-point Likert scale as none, some, quite, much, or extremely.
In our study, a 12-item short form will be used, suitable for our population of mildly intellectually disabled individuals.
In addition, a 12-item proxy form will be requested from parents or special education teachers for those who are able to complete it.
|
after 8 weeks of training
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSBU-BP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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