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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

Primary Purpose

Stroke

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Robot assisted arm training
Conventional rehabilitation
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic Rehabilitation

Conventional Rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
March 20, 2022
Last Updated
July 1, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05299853
Brief 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
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
June 25, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic Rehabilitation
Arm Type
Experimental
Arm Title
Conventional Rehabilitation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Robot assisted arm training
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Conventional rehabilitation
Intervention Description
Patients will receive 30 sessions of conventional arm training (60 minutes/day) for a total of 6 weeks (5 sessions/week).
Primary Outcome Measure Information:
Title
Change of baseline maximum inspiratory pressure
Description
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.
Time Frame
Baseline, Post-intervention ( 6 weeks)
Title
Change of baseline maximum expiratory pressure
Description
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.
Time Frame
Baseline, Post-intervention ( 6 weeks)
Title
Change from baseline ABILHAND
Description
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.
Time Frame
Baseline, Post-intervention ( 6 weeks)
Secondary Outcome Measure Information:
Title
Change from baseline Stroke Impact Scale
Description
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).
Time Frame
Baseline, Post-intervention ( 6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
City
Istanbul
ZIP/Postal Code
34160
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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