Manual Therapy and Inspiratory Muscle Training in Neuromuscular Disease

NCT07416929 | Completed

• 1 other identifier: Protocol no:21-41
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Disease; Inspiratory Muscle Training; Manual Therapy

Keywords

Pulmonary function; Fatigue; Neuromuscular disease; Inspiratory Muscle Training; Manual Therapy

Outcome Measures

Primary Outcomes (8)

• 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

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  Baseline and end of Week 6

Secondary Outcomes (4)

• Trunk Impairment Scale (TIS)

  Baseline and end of Week 6

• Timed Up and Go Test (TUG)

  Baseline and end of Week 6

• Sit and Reach Test:

  Baseline and end of Week 6

• Functional Reach Test (FRT)

  Baseline and end of Week 6

Study Arms (2)

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

Other: inspiratory muscle training; Other: Manual therapy

control group

OTHER

Only conventional physiotherapy program was applied to the control group

Other: Conventional physiotherapy programme

Interventions

inspiratory muscle training OTHER

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

study group

Manual therapy OTHER

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

study group

Conventional physiotherapy programme OTHER

Conventional physiotherapy includes therapeutic, strengthening and stretching exercises, electrotherapy approaches to pain

control group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Presence of a respiratory infection
• Presence of a serious cardiac condition
• History of a fracture involving the thoracic region

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

İstinye Üniversitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neuromuscular Diseases; Fatigue

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phd

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 18, 2026
• Study Start: August 15, 2021
• Primary Completion: January 15, 2022
• Study Completion: August 15, 2022
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)