Manual Therapy and Inspiratory Muscle Training in Neuromuscular Disease

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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Disease; Inspiratory Muscle Training; Manual Therapy
• Intervention / Treatment: Other: inspiratory muscle training; Other: Manual therapy; Other: Conventional physiotherapy programme

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • İstinye Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study 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	Other: inspiratory 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; Other: Manual 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
Other: control group; Only conventional physiotherapy program was applied to the control group	Other: Conventional physiotherapy programme; Conventional physiotherapy includes therapeutic, strengthening and stretching exercises, electrotherapy approaches to pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline and end of Week 6

Collaborators and Investigators

• Sponsor: Istinye University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): January 15, 2022
• Study Completion (Actual): August 15, 2022

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Fatigue; Inspiratory Muscle Training; Pulmonary function; Manual Therapy; Neuromuscular disease
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fatigue; Neuromuscular Diseases; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Musculoskeletal Manipulations
• Other Study ID Numbers: Protocol no:21-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Plan Description: Individual participant data will not be shared.

Access Criteria: Data sharing is not planned due to ethical and confidentiality considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No