Neuromuscular DiseaseNCT07416929
Manual Therapy and Inspiratory Muscle Training in Neuromuscular Disease
A study testing inspiratory muscle training, Manual therapy and Conventional physiotherapy programme in people with Neuromuscular Disease and Inspiratory Muscle Training, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The benefits of inspiratory muscle training (IMT) have been reported in neuromuscular diseases. However, its effects are limited. Further research is needed in new and complementary modalities demonstrating IMT efficacy in neuromuscular diseases. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Neuromuscular Disease, Inspiratory Muscle Training, Manual Therapy
- What is being tested?
- inspiratory muscle training, Manual therapy and Conventional physiotherapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2021to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Aged between 7 and 18 years
- Diagnosed with a muscle disease
- Voluntary participation
- Cooperative and coherent
- No hearing or visual impairment
- Ability to ambulate independently
Who cannot join
- Presence of a respiratory infection
- Presence of a serious cardiac condition
- History of a fracture involving the thoracic region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combined Manual Therapy and Inspiratory Muscle Training on Respiratory Function, Dyspnea and Trunk Control in Neuromuscular Disease
The benefits of inspiratory muscle training (IMT) have been reported in neuromuscular diseases. However, its effects are limited. Further research is needed in new and complementary modalities demonstrating IMT efficacy in neuromuscular diseases. This study aimed to investigate the effect of combined IMT and manual therapy in neuromuscular diseases.
Twenty-eight children with a diagnosis of muscle disease were included in the study. Only conventional physiotherapy program was applied to the control group. In the study group, in addition to the conventional physiotherapy program, manual therapy techniques were applied 3 days a week and IMT 2 times a day, 5 days a week for 6 weeks. Lung function test, respiratory muscle strength, fatigue and dyspnea assessment, corbin posture analysis, sit-reach test, functional reach test (FRT), timed up and go test (TUG), motor function measure (MFM) and trunk impairment scale (TIS) were used in the evaluations.
- Being tested
- inspiratory muscle training, Manual therapy, Conventional physiotherapy programme
- Keywords
- Pulmonary function, Fatigue, Neuromuscular disease, Inspiratory Muscle Training, Manual Therapy
- Medical subject headings
- Neuromuscular Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory muscle trainingOther
IMT was performed using the Threshold IMT (Respironics, USA) respiratory training device with threshold loading technique at 30% of maximum inspiratory pressure for 15 minutes twice a day (total of 30 minutes daily), 5 days a week for 6 weeks. The new maximum inspiratory pressure was measured every week, and the respiratory exercise device resistance was adjusted according to the new value and the workload was increased
Manual therapyOther
Suboccipital release, rib raising, diaphragm, anterior thoracic and sternal myofascial release, anterior cervical myofascial release, costal ligament release, lymph pump, scalene, pectoral, latissimus dorsi and serratus anterior energy techniques were used as the manual therapy approach. Myofascial release techniques were applied for 1-3 minutes each. Mobilisation was performed for 30 seconds and 5 repetitions in each joint. The manual therapy protocol session lasted 20-25 minutes. The manual therapy protocol was applied 3 days a week for 6 weeks, for a total of 18 sessions
Conventional physiotherapy programmeOther
Conventional physiotherapy includes therapeutic, strengthening and stretching exercises, electrotherapy approaches to pain
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | In the study group, in addition to the conventional physiotherapy program, manual therapy techniques were applied 3 days a week and IMT 2 times a day, 5 days a week for 6 weeks Receives: Other: inspiratory muscle training; Other: Manual therapy |
| control group | Other | Only conventional physiotherapy program was applied to the control group Receives: Other: Conventional physiotherapy programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Muscle Strength
Respiratory muscle strength was measured using Cosmed Pony FX® (US) mouth pressure measuring device. Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) were measured. Measurements were recorded before treatment, after the 9th treatment session, and following the 18th session
Measured: Baseline and end of Week 6
Peak flow rate (PEF)
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. Peak flow rate (PEF) (liters/second) will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). PEF will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
Measured: Baseline, end of Week 3 and end of Week 6
Forced expiratory volume in the first second (FEV1)
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. Forced expiratory volume in the first second (FEV1)(liters) will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). FEV1 will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
Measured: Baseline, end of Week 3 and end of Week 6
Forced vital capacity (FVC)
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. Forced vital capacity (FVC) (liters) will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). FVC will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
Measured: Baseline, end of Week 3 and end of Week 6
FEV1/FVC
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. FEV1/FVC ratio will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). FEV1/FVC will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
Measured: Baseline, end of Week 3 and end of Week 6
Fatigue and Dyspnea
Fatigue and dyspnea were subjectively assessed using a visual analogue scale (VAS). Individuals were asked to rate the feeling of fatigue and dyspnea on the scale as 0: none, 10: severe.
Measured: Baseline and end of Week 6
Posture assessment
Corbin posture scale was used. Lateral and posterior postural scores were summed and recorded as (0-2: excellent, 3-4: very good, 5-7: good, 8-11: fair, 12≥ poor).
Measured: Baseline and end of Week 6
Motor Function Measure (MFM):
The MFM is designed to evaluate motor performance and track changes over time in individuals with neuromuscular disorders. It includes 32 items divided into three domains: standing and transfers (D1, 13 items), axial and proximal function (D2, 12 items), and distal function (D3, 7 items). Each item is rated from 0 (unable to perform) to 3 (complete performance), resulting in a maximum total score of 96. Higher scores reflect better motor abilities and lower levels of functional impairment.
Measured: Baseline and end of Week 6
Secondary outcomes (4)
Trunk Impairment Scale (TIS)
The TIS is a tool used to assess the functional strength of the trunk, postural stability, and quality of trunk movements. It includes three subscales: static balance, dynamic balance, and coordination. The total score ranges from 0 to 23, where higher scores reflect better trunk control and function, while lower scores indicate greater impairment.
Measured: Baseline and end of Week 6
Timed Up and Go Test (TUG)
The TUG test is a practical tool for evaluating functional mobility in children. The child rises from a chair, walks 3 meters, turns, returns, and sits down. Timing begins upon standing and ends when seated. In children aged 3-18 years, a normal completion time is generally 5-6 seconds. Longer durations may indicate mobility or balance difficulties, while shorter times reflect typical or above-average motor performance.
Measured: Baseline and end of Week 6
Sit and Reach Test:
It was used to measure lower back and hamstring flexibility. Individuals were asked to sit on the floor and lean the trunk forward with the sole of the foot resting on the test stand and reach forward as far as possible with the hands. At the last point, 2 seconds were waited, and the value was recorded.
Measured: Baseline and end of Week 6
Functional Reach Test (FRT)
It is performed for standing dynamic balance assessment. The person is asked to raise the arm with the shoulder in 90° flexion and reach forwards. The distance reached without disturbing the balance was recorded. In healthy people, this distance is 45-50 cm on average.
Measured: Baseline and end of Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start15 Aug 2021
- Primary completion15 Jan 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseaseStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Çağlıyan Erdoğan, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416929
- Sponsor's protocol ID
- Protocol no:21-41
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan Description: Individual participant data will not be shared. Access Criteria: Data sharing is not planned due to ethical and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Manual Therapy and Inspiratory Muscle Training on Respiratory Function, Dyspnea and Trunk Control in Neuromuscular Disease
- ClinicalTrials.gov ID
- NCT07416929
- Acronym / sponsor ID
- Protocol no:21-41
- Keywords
- Pulmonary function, Fatigue, Neuromuscular disease, Inspiratory Muscle Training, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The benefits of inspiratory muscle training (IMT) have been reported in neuromuscular diseases. However, its effects are limited. Further research is needed in new and complementary modalities demonstrating IMT efficacy in neuromuscular diseases. This study aimed to investigate the effect of combined IMT and manual therapy in neuromuscular diseases.
Twenty-eight children with a diagnosis of muscle disease were included in the study. Only conventional physiotherapy program was applied to the control group. In the study group, in addition to the conventional physiotherapy program, manual therapy techniques were applied 3 days a week and IMT 2 times a day, 5 days a week for 6 weeks. Lung function test, respiratory muscle strength, fatigue and dyspnea assessment, corbin posture analysis, sit-reach test, functional reach test (FRT), timed up and go test (TUG), motor function measure (MFM) and trunk impairment scale (TIS) were used in the evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: inspiratory muscle training, Other: Manual therapyIn the study group, in addition to the conventional physiotherapy program, manual therapy techniques were applied 3 days a week and IMT 2 times a day, 5 days a week for 6 weeks |
| control group | Other | Other: Conventional physiotherapy programmeOnly conventional physiotherapy program was applied to the control group |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Aged between 7 and 18 years
- Diagnosed with a muscle disease
- Voluntary participation
- Cooperative and coherent
- No hearing or visual impairment
Key exclusion criteria (3 listed)
- Presence of a respiratory infection
- Presence of a serious cardiac condition
- History of a fracture involving the thoracic region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory muscle trainingIMT was performed using the Threshold IMT (Respironics, USA) respiratory training device with threshold loading technique at 30% of maximum inspiratory pressure for 15 minutes twice a day (total of 30 minutes daily), 5 days a week for 6 weeks. The new maximum inspiratory pressure was measured every week, and the respiratory exercise device resistance was adjusted according to the new value and the workload was increased | Other | study group |
| Manual therapySuboccipital release, rib raising, diaphragm, anterior thoracic and sternal myofascial release, anterior cervical myofascial release, costal ligament release, lymph pump, scalene, pectoral, latissimus dorsi and serratus anterior energy techniques were used as the manual therapy approach. Myofascial release techniques were applied for 1-3 minutes each. Mobilisation was performed for 30 seconds and 5 repetitions in each joint. The manual therapy protocol session lasted 20-25 minutes. The manual therapy protocol was applied 3 days a week for 6 weeks, for a total of 18 sessions | Other | study group |
| Conventional physiotherapy programmeConventional physiotherapy includes therapeutic, strengthening and stretching exercises, electrotherapy approaches to pain | Other | control group |
Primary outcome
Respiratory Muscle Strength
Time frame: Baseline and end of Week 6
Respiratory muscle strength was measured using Cosmed Pony FX® (US) mouth pressure measuring device. Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) were measured. Measurements were recorded before treatment, after the 9th treatment session, and following the 18th session
Peak flow rate (PEF)
Time frame: Baseline, end of Week 3 and end of Week 6
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. Peak flow rate (PEF) (liters/second) will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). PEF will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
Forced expiratory volume in the first second (FEV1)
Time frame: Baseline, end of Week 3 and end of Week 6
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. Forced expiratory volume in the first second (FEV1)(liters) will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). FEV1 will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
Forced vital capacity (FVC)
Time frame: Baseline, end of Week 3 and end of Week 6
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. Forced vital capacity (FVC) (liters) will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). FVC will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
FEV1/FVC
Time frame: Baseline, end of Week 3 and end of Week 6
Measurement will be made with a spirometer. The test will start with inspiration-expiration at tidal volume. Then a deep inspiratory manoeuvre will be followed by a rapid expiration. FEV1/FVC ratio will be recorded. The measured values will be expressed as a percentage of the expected values according to height, age, gender and body weight (Miller et al., 2005). FEV1/FVC will be performed with a spirometer (Cosmed Pony FX, Italy) according to ATS/ ERS criteria. Appropriate sterilisation method recommended by the guideline, disposable, personalised mouthpieces and filters will be used against the risk of infection.
Fatigue and Dyspnea
Time frame: Baseline and end of Week 6
Fatigue and dyspnea were subjectively assessed using a visual analogue scale (VAS). Individuals were asked to rate the feeling of fatigue and dyspnea on the scale as 0: none, 10: severe.
Posture assessment
Time frame: Baseline and end of Week 6
Corbin posture scale was used. Lateral and posterior postural scores were summed and recorded as (0-2: excellent, 3-4: very good, 5-7: good, 8-11: fair, 12≥ poor).
Motor Function Measure (MFM):
Time frame: Baseline and end of Week 6
The MFM is designed to evaluate motor performance and track changes over time in individuals with neuromuscular disorders. It includes 32 items divided into three domains: standing and transfers (D1, 13 items), axial and proximal function (D2, 12 items), and distal function (D3, 7 items). Each item is rated from 0 (unable to perform) to 3 (complete performance), resulting in a maximum total score of 96. Higher scores reflect better motor abilities and lower levels of functional impairment.
4 secondary outcomes
Trunk Impairment Scale (TIS)
Time frame: Baseline and end of Week 6
Timed Up and Go Test (TUG)
Time frame: Baseline and end of Week 6
Sit and Reach Test:
Time frame: Baseline and end of Week 6
Functional Reach Test (FRT)
Time frame: Baseline and end of Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. Plan Description: Individual participant data will not be shared. Access Criteria: Data sharing is not planned due to ethical and confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory muscle training, Manual therapy and Conventional physiotherapy programme in people with Neuromuscular Disease and Inspiratory Muscle Training, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength (time frame: Baseline and end of Week 6). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.