An interventional study of Thoracic Expansion Exercises and Motor Imagery-Supported Thoracic Expansion Exercises in Spina Bifida, sponsored by Karabuk University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Karabuk University · Not applicable, Interventional, and Treatment
This study will investigate whether adding motor imagery to thoracic expansion exercises can improve respiratory function in children with spina bifida. Motor imagery involves mentally imagining a movement or bodily action without physically performing an additional movement.
Children with spina bifida will participate in two exercise sessions separated by a 14-day washout period. In one session, participants will perform thoracic expansion exercises alone. In the other session, the same thoracic expansion exercises will be combined with guided motor imagery. The order of the two sessions will be randomized.
Respiratory function will be assessed before and immediately after each session. The primary outcome will be the change in forced vital capacity (FVC). Additional outcomes will include forced expiratory volume in one second (FEV1), forced expiratory flow at 25-75% of forced vital capacity (FEF25-75), peak expiratory flow (PEF), chest expansion, and peripheral oxygen saturation (SpO2).
The study aims to determine whether combining motor imagery with thoracic expansion exercises produces greater immediate improvements in respiratory function than thoracic expansion exercises alone.
Children with spina bifida may experience impaired trunk muscle control, thoracic deformity, reduced chest wall mobility, and limitations in respiratory function. Thoracic expansion exercises are commonly used in respiratory rehabilitation to facilitate chest wall movement and ventilation. However, evidence regarding specific respiratory rehabilitation strategies for children with spina bifida remains limited.
Motor imagery is a cognitive process in which an individual mentally simulates a movement or bodily action without performing an additional physical movement. Motor imagery has been used in neurorehabilitation to facilitate motor planning, body awareness, and motor learning. Its integration with respiratory exercises may enhance attention to thoracic movement and respiratory control, but this approach has not been adequately investigated in children with spina bifida.
This study is designed as a randomized, two-sequence, two-period crossover trial investigating the acute effects of motor imagery-supported thoracic expansion exercises on respiratory function in children with spina bifida. Participants will be randomly assigned to one of two intervention sequences. Sequence AB will receive thoracic expansion exercises alone during Period 1 and motor imagery-supported thoracic expansion exercises during Period 2. Sequence BA will receive the interventions in the reverse order. The two intervention periods will be separated by a 14-day washout interval.
Each intervention session will last approximately 15 minutes. Thoracic expansion exercises will target the upper, middle, and lower thoracic regions. During the motor imagery-supported condition, participants will perform the same physical thoracic expansion exercises while receiving standardized guided imagery instructions designed to promote awareness of chest wall expansion during inspiration and relaxation during expiration.
Outcome assessments will be performed before and immediately after each intervention session. Forced vital capacity (FVC) will be designated as the primary outcome. Secondary respiratory outcomes will include forced expiratory volume in one second (FEV1), forced expiratory flow at 25-75% of forced vital capacity (FEF25-75), peak expiratory flow (PEF), chest expansion, and peripheral oxygen saturation (SpO2).
The principal comparison will evaluate whether the pre-to-post intervention change in FVC differs between motor imagery-supported thoracic expansion exercises and thoracic expansion exercises alone. Secondary analyses will examine corresponding changes in the other respiratory and chest mobility outcomes. The crossover design allows each participant to receive both interventions and serve as his or her own control.
152 studies on the registry are indexed under Spinal Dysraphism; 37 are open to participants now.
This study's planned enrollment of 30 is close to the median of 33 across 96 interventional studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →Karabuk University is the lead sponsor of 126 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
Participants assigned to Sequence AB will receive thoracic expansion exercises alone during Period 1, followed by a 14-day washout interval. During Period 2, they will receive motor imagery-supported thoracic expansion exercises.
Behavioral: Thoracic Expansion Exercises · Behavioral: Motor Imagery-Supported Thoracic Expansion Exercises
Participants assigned to Sequence BA will receive motor imagery-supported thoracic expansion exercises during Period 1, followed by a 14-day washout interval. During Period 2, they will receive thoracic expansion exercises alone.
Behavioral: Thoracic Expansion Exercises · Behavioral: Motor Imagery-Supported Thoracic Expansion Exercises
Participants will perform approximately 15 minutes of thoracic expansion exercises targeting the upper, middle, and lower thoracic regions. The physiotherapist will facilitate expansion of the targeted chest wall region during inspiration using standardized verbal and manual guidance. When appropriate, mild manual resistance may be applied during inspiration and individually adjusted according to the participant's ability.
Participants will perform the same approximately 15-minute thoracic expansion exercise protocol while receiving standardized guided motor imagery instructions. During inspiration, participants will be instructed to imagine the expansion of the chest as a rising wave, and during expiration to imagine the wave gradually receding. The imagery will be synchronized with thoracic expansion and the level of manual resistance applied by the physiotherapist.
Change in Forced Vital Capacity (FVC)
Forced vital capacity (FVC) will be measured by spirometry with the participant in a seated position using a nose clip. At least three technically acceptable maneuvers will be performed, and the best acceptable value will be recorded in liters (L). The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition. The primary analysis will compare the change in FVC between motor imagery-supported thoracic expansion exercises and thoracic expansion exercises alone.
Time frame: Before intervention and within 5 minutes after intervention in Period 1, and before intervention and within 5 minutes after intervention in Period 2; the two periods are separated by a 14-day washout interval.
Change in Forced Expiratory Volume in One Second (FEV1)
FEV1 will be measured by spirometry and recorded in liters (L). The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition.
Time frame: Before intervention and within 5 minutes after intervention in Period 1, and before intervention and within 5 minutes after intervention in Period 2; the two periods are separated by a 14-day washout interval.
Change in Forced Expiratory Flow at 25-75% of FVC (FEF25-75)
FEF25-75 will be obtained from spirometric assessment and recorded in liters per second (L/s). The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition.
Time frame: Before intervention and within 5 minutes after intervention in Period 1, and before intervention and within 5 minutes after intervention in Period 2; the two periods are separated by a 14-day washout interval.
Change in Peak Expiratory Flow (PEF)
Peak expiratory flow will be assessed using a peak flow meter. Three maximal expiratory efforts will be performed, and the highest value will be recorded. The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition.
Time frame: Before intervention and within 5 minutes after intervention in Period 1, and before intervention and within 5 minutes after intervention in Period 2; the two periods are separated by a 14-day washout interval.
Change in Chest Expansion
Chest expansion will be assessed using a measuring tape placed horizontally around the thorax. The difference between chest circumference at maximal inspiration and maximal expiration will be recorded in centimeters (cm). Three measurements will be performed and the mean value will be used. The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition.
Time frame: Before intervention and within 5 minutes after intervention in Period 1, and before intervention and within 5 minutes after intervention in Period 2; the two periods are separated by a 14-day washout interval.
Change in Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation (SpO2) will be assessed non-invasively using pulse oximetry and recorded as a percentage (%). The change from pre-intervention to immediately post-intervention will be calculated for each intervention condition.
Time frame: Before intervention and within 5 minutes after intervention in Period 1, and before intervention and within 5 minutes after intervention in Period 2; the two periods are separated by a 14-day washout interval.
Plan to share: Yes — De-identified individual participant data underlying the results reported in the published article will be available upon reasonable request. Data will be shared only for scientifically justified purposes and following approval of the request by the study investigators. Appropriate measures will be taken to protect participant confidentiality, and a data use agreement may be required.
Supporting information: Study protocol, Sap, Icf, Analytic code
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