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)

Status: Invitation-only

Conditions: Stroke

Treatments: Other: Conventional rehabilitation; Other: Robot assisted arm training

Study type: Interventional

Funder types: Other

Identifiers

NCT05299853

2017/34

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Robotic Rehabilitation

Experimental group

Treatment:

Other: Robot assisted arm training

Conventional Rehabilitation

Active Comparator group

Treatment:

Other: Conventional rehabilitation