Spina BifidaNCT07846202
Motor Imagery-Supported Thoracic Expansion in Children With Spina Bifida
A study testing Thoracic Expansion Exercises and Motor Imagery-Supported Thoracic Expansion Exercises in people with Spina Bifida, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Thoracic Expansion Exercises and Motor Imagery-Supported Thoracic Expansion Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2026to 5 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of spina bifida.
- Age between 7 and 18 years.
- Clinically stable, with no acute respiratory infection or respiratory distress.
- Ability to maintain a seated position.
- Sufficient cognitive ability to understand and follow verbal instructions.
- Written informed consent provided by the parent or legal guardian.
Who cannot join
- Acute respiratory tract infection or pneumonia.
- Chronic pulmonary disease.
- Severe scoliosis or severe thoracic deformity.
- Serious cardiac or metabolic disease.
- Inability to cooperate with the assessment or exercise procedures.
- Inability to understand or perform the motor imagery instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Karabuk University
Karabük, Karabük Province, 78050
Ece Acar, Assist Prof, 05457925035, acarkosanece@gmail.com
About this study
Official title: Acute Effects of Motor Imagery-Supported Thoracic Expansion Exercises on Respiratory Function in Children With Spina Bifida: A Randomized Crossover Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Spina Bifida
- Being tested
- Thoracic Expansion Exercises, Motor Imagery-Supported Thoracic Expansion Exercises
- Keywords
- Motor Imagery, Thoracic Expansion Exercises, Respiratory Function, Pulmonary Function, Forced Vital Capacity, Pediatric Rehabilitation
- Medical subject headings
- Spinal Dysraphism, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Expansion ExercisesBehavioural
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.
Motor Imagery-Supported Thoracic Expansion ExercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Experimental | 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. Receives: Behavioral: Thoracic Expansion Exercises; Behavioral: Motor Imagery-Supported Thoracic Expansion Exercises |
| Sequence BA | Experimental | 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. Receives: Behavioral: Thoracic Expansion Exercises; Behavioral: Motor Imagery-Supported Thoracic Expansion Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start12 Oct 2026 (estimated)
- Primary completion18 Dec 2026 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, two-sequence, two-period crossover trial. Participants will be randomly assigned in a 1:1 ratio to one of two intervention sequences. Sequence AB will receive thoracic expansion exercises alone in Period 1 and motor imagery-supported thoracic expansion exercises in Period 2. Sequence BA will receive the same interventions in the reverse order. The two intervention periods will be separated by a 14-day washout interval. Each participant will receive both interventions and will serve as his or her own control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece ACAR, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846202
- Sponsor's protocol ID
- KBU-SB-MI-TE-2026-01
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Stanojevic S, Kaminsky DA, Miller MR, Thompson B, Aliverti A, Barjaktarevic I, Cooper BG, Culver B, Derom E, Hall GL, Hallstrand TS, Leuppi JD, MacIntyre N, McCormack M, Rosenfeld M, Swenson ER. ERS/ATS technical standard on interpretive strategies for routine lung function tests. Eur Respir J. 2022 Jul 13;60(1):2101499. doi: 10.1183/13993003.01499-2021. Print 2022 Jul.
PubMed 34949706Saleem GT. Defining and measuring motor imagery in children: mini review. Front Psychol. 2023 Aug 16;14:1227215. doi: 10.3389/fpsyg.2023.1227215. eCollection 2023.
PubMed 37655192Behrendt F, Zumbrunnen V, Brem L, Suica Z, Gaumann S, Ziller C, Gerth U, Schuster-Amft C. Effect of Motor Imagery Training on Motor Learning in Children and Adolescents: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Sep 8;18(18):9467. doi: 10.3390/ijerph18189467.
PubMed 34574389Azab AR, Abdelbasset WK, Alrawaili SM, Elsayed AEA, Hajelbashir MI, Kamel FH, Basha MA. Effect of Chest Resistance and Expansion Exercises on Respiratory Muscle Strength, Lung Function, and Thoracic Excursion in Children with a Post-Operative Congenital Diaphragmatic Hernia. Int J Environ Res Public Health. 2022 May 17;19(10):6101. doi: 10.3390/ijerph19106101.
PubMed 35627640Martins EJ, Gastaldi AC, Davoli GBQ, Leonardi-Figueiredo MM, Mattiello-Sverzut AC. Decreased respiratory performance of children and adolescents with myelomeningocele who use a wheelchair - preliminary data. Braz J Med Biol Res. 2019;52(8):e8671. doi: 10.1590/1414-431X20198671. Epub 2019 Aug 5.
PubMed 31389492