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Clinical Trials/NCT04903392
NCT04903392
Unknown
Not Applicable

Investigation of the Effects of Gait Training on Balance, Plantar Pressure Distribution and Respiratory Parameters in Chronic Stroke Patients

Bandırma Onyedi Eylül University1 site in 1 country28 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Stroke Patients
Sponsor
Bandırma Onyedi Eylül University
Enrollment
28
Locations
1
Primary Endpoint
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Last Updated
4 years ago

Overview

Brief Summary

Loss of motor control after stroke, muscle weakness, abnormal movement patterns, spasticity, range of motion limitations and sensory dysfunction, resulting in a decrease in the load transferred to the affected limb, changes in gait pattern and balance skills. Post-stroke muscle weakness has been shown to occur not only in the lower and upper extremity muscles but also in the respiratory muscles. It was found that the plantar pressure distribution in the affected side feet was decreased in individuals with stroke and this situation negatively affected the walking function. A systematic review of treadmill training revealed that treadmill training significantly increased walking speed and walking distance. Learning to walk backwards is also recommended to improve the movement components required for walking forward. As a result of the investigations, although there are studies about the effects of back-walking training on walking and balance function in chronic stroke patients, there is no study investigating the effects on plantar pressure distribution and respiratory parameters. Therefore, this study, which planned to investigate the effects of treadmill retching training on balance, plantar pressure distribution and respiratory parameters in chronic stroke patients, will contribute to the literature.

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
December 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bandırma Onyedi Eylül University
Responsible Party
Principal Investigator
Principal Investigator

Burçin Akçay

Assistant Professor

Bandırma Onyedi Eylül University

Eligibility Criteria

Inclusion Criteria

  • Volunteering to participate in the study
  • More than 6 months have passed since the onset of stroke
  • First time stroke diagnosis
  • Being between the ages of 40-65
  • Spasticity severity in lower extremity less than 3 according to Modified Ashworth Scale,
  • Being medically stable
  • Ability to walk 10 meters and above without assistance

Exclusion Criteria

  • Presence of other neurological or orthopedic diseases that affect standing and walking involving the lower limbs
  • Uncontrollable Hypertension
  • Having been diagnosed with any pulmonary disease
  • Severe cardiac conditions
  • Uncontrollable DM
  • Lack of cooperation

Outcomes

Primary Outcomes

Pulmonary function (Forced expiratory volume in the first second (FEV1))

Time Frame: 6 weeks

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.

Plantar pressure assessment

Time Frame: 6 weeks

Plantar pressure distribution will be evaluated.

Pulmonary function (Forced vital capacity (FVC))

Time Frame: 6 weeks

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.

Pulmonary function (FEV1 / FVC)

Time Frame: 6 weeks

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.

Pulmonary function (Peak flow rate (PEF))

Time Frame: 6 weeks

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.

Respiratory Muscle Strength

Time Frame: 6 weeks

Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device

Balance assessment

Time Frame: 6 weeks

Static and dynamic balance will be evaluated with The Korebalance Premiere device.

Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

Time Frame: 6 weeks

Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.

Study Sites (1)

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