Stroke Clinical Trial
Official title:
The Investigation of the Effects of Robot-Assisted Rehabilitation on Respiratory Parameters, Dyspnea and Functional Capacity in Individuals With Stroke
Verified date | January 2024 |
Source | Biruni University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Stroke has a high rate of morbidity and mortality worldwide. This disease is the third leading cause of death after ischemic heart disease and cancer. Stroke is also the leading cause of disability in adults. It is known that stroke individuals have not only limb restriction, but also respiratory capacity and exercise capacity. It has been shown in the literature that upper extremity functions are directly related to respiratory capacity. Although it is known that upper extremity training has positive effects on respiratory capacity in stroke individuals, more studies are needed to examine the effects of upper extremity robot-assisted rehabilitation on respiratory capacity. The aim of this study is to examine the effects of upper extremity robot-assisted rehabilitation applied in addition to conventional treatment on respiratory parameters, dyspnea, and functional capacity.
Status | Completed |
Enrollment | 34 |
Est. completion date | October 15, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria : - Between the ages of 18-65, - Diagnosed with hemorrhagic or ischemic stroke, - Having a stroke history of at least 3 months, - Being 16 and above according to the Mini-Mental State Test, - Three and above according to the Brunnstrom stage, - Individuals not included in another rehabilitation program will be included. Exclusion Criteria: - Chronic cardiac or pulmonary diseases such as COPD, asthma, interstitial lung disease, and heart failure, - Using tobacco and tobacco products, - Severe spasticity to prevent robotic rehabilitation (on Modified Ashworth Scale, - With skin ulcers, - Non-union or unstable fracture status, - Individuals with pressure sores will not be included. |
Country | Name | City | State |
---|---|---|---|
Turkey | Biruni University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Biruni University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio | Spirometric evaluation will be performed to determine the FEV1/FVC value of the participants. | Change from Baseline Forced expiratory volume 1. second (FEV1)/ Forced vital capacity (FVC) ratio at 6 weeks | |
Primary | Maximal inspiratory pressure | Mouth pressure will be assessed to document inspiratory muscle strength | Change from Baseline Maximal inspiratory pressure at 6 weeks | |
Primary | Maximal expiratory pressure | Mouth pressure will be assessed to document expiratory muscle strength | Change from Baseline Maximal expiratory pressure at 6 weeks | |
Primary | Peak Expiratory Flow Rate | Spirometric assessment will be performed to determine participants' peak expiratory flow rate. | Change from Baseline Peak Expiratory Flow Rate at 6 weeks | |
Secondary | Peak cough flow | Peak cough flow will be measured in triplicate during the "maximal coughing manoeuvre" with a digital PEFmeter. | Change from Baseline Peak cough flow at 6 weeks | |
Secondary | 6 Minutes Walking Test | The 6 minutes walk test is a sub-maximal exercises test use to assess aerobic capacity and endurance. | Change from Baseline 6 Minutes Walking Test at 6 weeks | |
Secondary | Time Up and Go Test | The test evaluates the dynamic balance and mobility. | Change from Baseline Time Up and Go Test at 6 weeks | |
Secondary | Dyspnea-12 Scale | The dyspnea perception will be measured with this scale. There are 12 descriptor items on this scale ranging none (0), mild (1), moderate (2) or severe (3). It provides an overall score for breahtlessness severity that incorporates seven physical items and five affective items. | Change from Baseline Dyspnea-12 Scale at 6 weeks | |
Secondary | Satisfaction survey | This text is used to assess patients' satisfaction. Evaluation will be scored between c0-5 as a verbal response. 0 = not at all satisfied, 5 = very satisfied. | At 6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Suspended |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Enrolling by invitation |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Active, not recruiting |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|