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Clinical Trials/NCT05299853
NCT05299853
Unknown
Not Applicable

Effects of Robot-assisted Arm Training on Respiratory Muscle Strength, Activities of Daily Living and Quality of Life in Stroke Patients: A Single-blinded Randomized Controlled Trial

Istanbul University - Cerrahpasa (IUC)1 site in 1 country70 target enrollmentJanuary 20, 2022
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
70
Locations
1
Primary Endpoint
Change of baseline maximum inspiratory pressure
Last Updated
3 years ago

Overview

Brief Summary

Stroke is the leading neurological disease in the world that causes long-term disability. The most common cause of disability after stroke is motor impairment resulting from brain damage which ultimately cause respiratory and functional limitation. Respiratory muscle weakness including the diaphragm leads to biomechanical change in respiration which can reduce vital capacity and total lung capacity of stroke patients. The weakness of diaphragm and abdominal muscle also leads to decrease in maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) in stroke patients.

Respiratory muscle training such as inspiratory or expiratory muscle training is commonly used to improve the respiratory muscle strength and function in stroke. However, it was reported that respiration is closely related to upper limb function because the muscle of upper extremities surrounds the dorsal muscle of trunk and in order to breath, the movement of trunk is necessary, which in turn is related to the movement of the upper limbs.

Registry
clinicaltrials.gov
Start Date
January 20, 2022
End Date
July 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Ishtiaq Ahmed

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • 18 year and above
  • Acute and sub-acute stroke patients
  • had MIP values lower than 70% of those predicted when adjusted for age and sex,
  • had no facial palsy, aphasia, or dysarthria, which would prevent respiratory muscle strength testing
  • Ischemic or Hemorrhagic stroke
  • No medical history of respiratory or lung disease

Exclusion Criteria

  • patients with increased intracranial pressure, uncontrolled hypertension, decompensated heart failure, unstable angina, recent myocardial infarction, complicated arrhythmias, pneumothorax, bullae/blebs in the preceding 3 months
  • Any pulmonary or lungs disease
  • Any neurological conditions other than stroke
  • Using medications that could interfere with neuromuscular control or cause drowsiness.
  • Severe cognitive function (Mini-Mental Test result \<24)
  • Chronic stroke
  • Recurrent stroke, brain stem stroke, and aphasia were excluded.

Outcomes

Primary Outcomes

Change of baseline maximum inspiratory pressure

Time Frame: Baseline, Post-intervention ( 6 weeks)

Maximum inspiratory pressure (MIP) will be measure using a hand-held mouth pressure device. Three maximal manoeuvres will perform and the highest value record. Indirect measure of respiratory (inspiratory) muscle strength, expressed in cmH20.

Change of baseline maximum expiratory pressure

Time Frame: Baseline, Post-intervention ( 6 weeks)

Maximum expiratory pressure (MEP) will be measure using a hand-held mouth pressure device. Three maximal manoeuvres will perform and the highest value record. Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20.

Change from baseline ABILHAND

Time Frame: Baseline, Post-intervention ( 6 weeks)

A questionnaire to assess active function of the upper limbs with 23 activities, rated as impossible, difficult or easy. The scale is scored through Rasch analysis, providing a total score ranging from -6 to +6, with higher scores indicating a lower degree of upper extremity impairment.

Secondary Outcomes

  • Change from baseline Stroke Impact Scale(Baseline, Post-intervention ( 6 weeks))

Study Sites (1)

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