Neuromuscular Disease, Inspiratory Muscle Training, Manual Therapy
Conditions
Keywords
Pulmonary function, Fatigue, Neuromuscular disease, Inspiratory Muscle Training, Manual Therapy
Brief 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. 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.
Interventions
OTHERinspiratory muscle training
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
OTHERManual therapy
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 includes therapeutic, strengthening and stretching exercises, electrotherapy approaches to pain
Sponsors
Istinye University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Presence of a respiratory infection * Presence of a serious cardiac condition * History of a fracture involving the thoracic region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posture assessment | 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). |
| Respiratory Muscle Strength | 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) | 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) | 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) | 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 | 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 | 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. |
| Motor Function Measure (MFM): | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trunk Impairment Scale (TIS) | Baseline and end of Week 6 | 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. |
| Timed Up and Go Test (TUG) | Baseline and end of Week 6 | 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. |
| Sit and Reach Test: | Baseline and end of Week 6 | 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. |
| Functional Reach Test (FRT) | Baseline and end of Week 6 | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed