Clinical trial NCT05299853: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
First posted: 2022-03-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 18 year and above
2. Acute and sub-acute stroke patients
3. had MIP values lower than 70% of those predicted when adjusted for age and sex,
4. had no facial palsy, aphasia, or dysarthria, which would prevent respiratory muscle strength testing
5. Ischemic or Hemorrhagic stroke
6. No medical history of respiratory or lung disease

Exclusion Criteria:

1. 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
2. Any pulmonary or lungs disease
3. Any neurological conditions other than stroke
4. Using medications that could interfere with neuromuscular control or cause drowsiness.
5. Severe cognitive function (Mini-Mental Test result \<24)
6. Chronic stroke
7. Recurrent stroke, brain stem stroke, and aphasia were excluded.

Primary outcomes:
measure: Change of baseline maximum inspiratory pressure
timeFrame: Baseline, Post-intervention ( 6 weeks)
measure: Change of baseline maximum expiratory pressure
timeFrame: Baseline, Post-intervention ( 6 weeks)
measure: Change from baseline ABILHAND
timeFrame: Baseline, Post-intervention ( 6 weeks)
Secondary outcomes:
measure: Change from baseline Stroke Impact Scale
timeFrame: Baseline, Post-intervention ( 6 weeks)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Study officials:
References: