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

Stroke Clinical 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05299853
• Other study ID #: 2017/34
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: July 1, 2022
• Est. primary completion date: June 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Robot assisted arm training
Patients will receive 30 minutes of robot-assisted arm training and 30 minutes of conventional arm rehabilitation training. Patients will undergo 30 sessions of combined therapy (robotic+conventional) for a total of 6 weeks (5 sessions/week).
• Conventional rehabilitation
Patients will receive 30 sessions of conventional arm training (60 minutes/day) for a total of 6 weeks (5 sessions/week).

Locations

Country	Name	City	State
Turkey	Bakirköy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa	Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of baseline maximum inspiratory pressure	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.	Baseline, Post-intervention ( 6 weeks)
Primary	Change of baseline maximum expiratory pressure	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.	Baseline, Post-intervention ( 6 weeks)
Primary	Change from baseline ABILHAND	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.	Baseline, Post-intervention ( 6 weeks)
Secondary	Change from baseline Stroke Impact Scale	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).	Baseline, Post-intervention ( 6 weeks)