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

NCT05299853 | Unknown

• 1 other identifier: 2017/34
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (1)

• Change from baseline Stroke Impact Scale

  Baseline, Post-intervention ( 6 weeks)

Study Arms (2)

Robotic Rehabilitation

EXPERIMENTAL

Other: Robot assisted arm training

Conventional Rehabilitation

ACTIVE COMPARATOR

Other: Conventional rehabilitation

Interventions

Robot assisted arm training OTHER

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).

Robotic Rehabilitation

Conventional rehabilitation OTHER

Patients will receive 30 sessions of conventional arm training (60 minutes/day) for a total of 6 weeks (5 sessions/week).

Conventional Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: collaborator

Study Sites (1)

Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, 34160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: March 29, 2022
• Study Start: January 20, 2022
• Primary Completion: June 25, 2022
• Study Completion: July 1, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)