The Effects of Manual Therapy on the Spatiotemporal Gait Characteristics in Patients With Chronic Obstructive Pulmonary Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorHacettepe University

About this trial

The primary aim of this study is to investigate the effects of manual therapy on spatiotemporal characteristics of gait and gait variability, functional exercise capacity, and pulmonary function in patients with chronic obstructive pulmonary disease (COPD).

The secondary aims of the study are to determine the effects of manual therapy on balance, respiratory muscle strength, quality of life, physical activity, symptom severity, accessory respiratory muscle activation, peripheral muscle strength, chest wall mobility, dysfunctional breathing, pain, and posture.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 40 years or older

Clinically stable for at least the past 4 weeks

Classified as GOLD stage 1, 2, or 3 according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) airflow limitation classification

Classified as group A, B, or E according to the GOLD ABE assessment tool

Disqualifiers

Use of walking assistive devices

Receiving long-term oxygen therapy

Presence of additional orthopedic, neuromuscular, neurological, or cardiac conditions that may affect gait and balance

History of lung cancer, sarcoidosis, tuberculosis, and/or lung surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manual therapy Group

    Other intervention

    For muscle energy techniques, the post-isometric relaxation (PIR) technique will be applied. Participants will be instructed to perform an isometric contraction against mild resistance (20-30% of maximal effort), which will be maintained for 7-10 seconds, followed by a 3-second relaxation period. PIR applications will be performed bilaterally for each muscle group, in 2 sets with a total of 10 repetitions. The muscle groups to which MET will be applied include the pectoralis major and minor, upper trapezius, scalene muscles, sternocleidomastoid, and latissimus dorsi. For the diaphragmatic relaxation technique, the therapist will follow the elevation of the ribs and gently draw the contact points cranially and slightly laterally. During expiration, the therapist will maintain resistance by deepening the contact toward the internal costal margin. The maneuver will be applied in two sets of 10 deep breaths, with a 1-minute rest interval between sets.

  • Control group

    Other intervention

    Self-stretching and breathing exercise

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Manual therapy GroupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Spatiotemporal Gait Characteristics (Gait Analysis)

The spatiotemporal characteristics of gait and gait variability will be assessed using an electronic walkway system (GAITRite, CIR Systems Inc., Franklin, New Jersey, USA). GAITRite is a system with established reliability and validity for gait assessment in individuals with COPD. Data will be collected at the beginning and at the end of a six-minute walking period. Participants will walk at their self-selected pace. Gait data obtained at the beginning and at the end of the six-minute walk will be averaged for data analysis. Data normalization will be performed using participants' leg length (cm), height (cm), or body weight (kg) values.

Time frame
At the baseline and after the eight-week intervention
2

Spatial Gait Distance Parameters

Mean step length, stride length, and step width measured using the GAITRite electronic walkway system. Unit of Measure: meters (m)

Time frame
At the baseline and after the eight-week intervention
3

Temporal Gait Parameters

Mean stance phase duration, swing phase duration, stride time, and step time assessed using GAITRite. Unit of Measure: seconds (s)

Time frame
At the baseline and after the eight-week intervention
4

Gait Speed

Mean walking speed measured using the GAITRite system during self-selected pace walking. Unit of Measure: meters per second (m/s)

Time frame
At the baseline and after the eight-week intervention

Secondary outcomes

1

Respiratory muscle strength

Respiratory muscle strength will be determined by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) generated at the mouth using a mouth pressure device (Micro MPM; Micro Medical Ltd., Rochester, UK) with individual antibacterial and antiviral disposable filters. For MIP measurement, participants will be instructed to perform a maximal expiration; after the application of a nose clip, they will then perform a maximal inspiration for 1-3 seconds. For MEP measurement, participants will be instructed to perform a maximal inspiration; after the application of a nose clip, they will then perform a maximal expiration for 1-3 seconds. The tests will be repeated until no further improvement is observed and the difference between the two best values is less than 5%. The highest value will be recorded. Predicted normal values for respiratory muscle strength will be calculated using age- and sex-specific regression equations.

Time frame
At the baseline and after the eight-week intervention
2

Peripheral muscle strength

Peripheral muscle strength will be assessed using handgrip strength and the one-minute sit-to-stand test. Handgrip strength will be measured using a digital hand dynamometer (Baseline BIMS, Fabrication Enterprises Inc., USA).Participants will be instructed to grip the stabilized dynamometer with maximal force. Measurements will be repeated three times, and the highest value will be recorded. Participants will be seated freely on a chair with a height of 46 cm, with the hips and knees flexed at 90°, arms crossed over the chest, and feet positioned at hip width. They will then be instructed to stand up and sit down as many times as possible within one minute at their self-selected pace, without altering body posture. The total number of repetitions will be recorded. This repetition count will be expressed as a percentage of predicted reference values adjusted for sex, height, body weight, and age.

Time frame
At the baseline and after the eight-week intervention
3

Balance assessment

Balance and postural sway will be assessed using a three-component force platform (Bertec Model BP 5050; Bertec Corporation, Columbus, Ohio, USA). Participants will be asked to stand barefoot on the force platform for 10 seconds while maintaining a quiet standing position with a stance width equal to their support base. Postural sway will be evaluated under four different conditions: eyes open and eyes closed on both firm and compliant surfaces. Based on the data, a stability score calculated by the device software will also be expressed as a percentage. Stability limits in the anterior, posterior, right, and left directions will be recorded in centimeters and expressed as percentages.

Time frame
At the baseline and after the eight-week intervention
4

Accessory Muscle activation

Surface electromyography will be used to assess accessory respiratory muscle activation using the Trigno™ system (Delsys Inc., Natick, MA, USA). Four channels will be utilized for data acquisition. To minimize signal crosstalk, electrode placement will be determined in accordance with the recommendations of the Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM) guidelines. Activation of the most commonly investigated accessory respiratory muscles will be assessed bilaterally at rest. The muscles evaluated will include the sternocleidomastoid, pectoralis major, upper trapezius, and latissimus dorsi. A standardized maximal voluntary contraction (MVC) protocol will be applied for each muscle. EMG values will be normalized to the MVC obtained for the corresponding muscle and expressed as a percentage of MVC (%MVC).

Time frame
At the baseline and after the eight-week intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: