NCT07846202

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

October 12, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2027

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 10, 2026

Last Update Submit

September 25, 2026

Conditions

Keywords

Motor ImageryThoracic Expansion ExercisesRespiratory FunctionPulmonary FunctionForced Vital CapacityPediatric Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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)

    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)

    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

    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)

    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.

Study Arms (2)

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.

Behavioral: Thoracic Expansion ExercisesBehavioral: 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.

Behavioral: Thoracic Expansion ExercisesBehavioral: Motor Imagery-Supported Thoracic Expansion Exercises

Interventions

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.

Sequence ABSequence BA

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.

Sequence ABSequence BA

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, Karabük Province, 78050, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 34949706BACKGROUND
  • Saleem 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.

    PMID: 37655192BACKGROUND
  • Behrendt 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.

    PMID: 34574389BACKGROUND
  • Azab 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.

    PMID: 35627640BACKGROUND
  • Martins 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.

    PMID: 31389492BACKGROUND

MeSH Terms

Conditions

Spinal DysraphismRespiratory Aspiration

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be blinded to the intervention sequence and treatment condition. Intervention sessions will be administered by a physiotherapist who is not involved in outcome assessment. Participants will be instructed not to disclose the intervention received to the blinded assessor.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 29, 2026

Study Start (Estimated)

October 12, 2026

Primary Completion (Estimated)

December 18, 2026

Study Completion (Estimated)

February 5, 2027

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Beginning 3 months after publication of the primary study results and available for 5 years.
Access Criteria
Data will be made available to qualified researchers who submit a methodologically sound proposal. Requests will be reviewed by the principal investigator and study team. Data will be provided for analyses consistent with the approved proposal and subject to appropriate confidentiality and data-use requirements.

Locations