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

Not Applicable

• Conditions: Stroke
• Interventions: Other: Robot assisted arm training; Other: Conventional rehabilitation

• Registration Number: NCT05299853
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-20
• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-03-20
• Study First Posted: 2022-03-29
• Primary Completion: 2022-06-25
• Status Verified: 2022-07
• Study Completion: 2022-07-01
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic Rehabilitation	Robot assisted arm training	-
Conventional Rehabilitation	Conventional rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Change of baseline maximum inspiratory pressure	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	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	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 Outcome Measures

Name	Time	Method
Change from baseline Stroke Impact Scale	Baseline, Post-intervention ( 6 weeks)	A stroke-specific health status measure featuring 16 items capturing daily activities. This scale has 8 sub-scales, evaluating: strength, hand function, mobility, activities of daily living, emotion, memory, communication and social participation. Each is rated on a 0 to 100 range (100 corresponding to least impact of stroke). An overall score is also calculated (average of sub-scales).

Trial Locations

Locations (1)

Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi; 🇹🇷 Istanbul, Turkey