Stroke Clinical Trial
Official title:
Does Moderate Intensity Aerobic Training Influence Serum Levels of BDNF in Sub-acute and Chronic Stroke Patients and Consequently Increase the Efficacy of Upper-limb Rehabilitation? A Study Protocol for a Randomized Control Trial With an Embedded Health Economic Evaluation.
Verified date | December 2022 |
Source | Technical University of Bern |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the influence on three different training modalities on the blood concentration levels of a growth factor called Brain Derived Neurotrophic Factor (BDNF) and on the recovery of arm function following in sub-acute and chronic stroke survivors. The training modalities are 1. moderate intensity aerobic training on a bike ergonometer followed by robotic or sensor-based upper-limb training, 2. non-aerobic circuit training followed by robotic or sensor-based upper-limb training 3. circuit training alone.
Status | Completed |
Enrollment | 17 |
Est. completion date | September 1, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Hemiplegic stroke ischemic or intracerebral hemorrhagic > 3 months post- stroke - Active shoulder abduction, wrist and finger extension 10 degrees from a flexed position Exclusion Criteria: - Contraindications to maximal exercise testing according to the American College of Sports Medicine guidelines - Severe perceptual problems - Concurrent neurological diagnoses e.g. Parkinsons disease - Comorbidities which may interfere with exercise participation - Significant cognitive impairment < 24 on the Montreal Cognitive Assessment Scale |
Country | Name | City | State |
---|---|---|---|
Switzerland | RehaB clinic for Neurorehabilitation and Paraplegiology | Basel |
Lead Sponsor | Collaborator |
---|---|
Clare Maguire | Bildungszetrum Gesundheit Basel-Stadt, Rehab Basel |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BDNF | Acute (immediate post exercise) and chronic (post-intervention) serum BDNF levels | 12 weeks | |
Primary | Action Research Arm Test (ARAT) | A 19-Item standardised assessment of UL function measuring ADLs, coordination & dexterity. | 12 weeks | |
Secondary | The Fugl-Meyer Assessment - Upper Extremity Scale (FMA). | Instrument for measuring upper limb impairment after stroke. The Fugl-Meyer Assessment - Upper Extremity Scale (FMA). This is reliable, responsive and valid instrument for measuring upper limb impairment after stroke. Items are scored on a three-point ordinal scale: 0=cannot perform, 1=performs partially, 2=performs fully. Maximal Score 66. | 12 weeks | |
Secondary | 10 meter walking test | A measurement of gait speed | 12 weeks | |
Secondary | Trunk Sway in standing with eyes closed | Standing balance | 12 weeks | |
Secondary | The Montreal Cognitive Assessment (MoCA©). | This is a rapid screen of cognitive performance to detect mild cognitive dysfunction. The test consists of 16 items and 11 categories to assess multiple cognitive domains. The maximal score is 30. | 12 weeks | |
Secondary | Corsi Block Test | Evaluates visuospatial short-term working memory | 12 weeks | |
Secondary | The Fatigue Severity Scale (FSS) | Measures post-stroke-fatigue. This is a 9-item, 7 point linkert scale scale which measures the effect of fatigue on activities and lifestyle. The higher the score the worse the fatigue. | 12 weeks | |
Secondary | Stroke Impact Scale | A disease specific Quality of Life measure.This is a 59 item measure in which 8 domains are assessed. Each item is a 5-point Linkert scale related to difficulty completing the scale . Summative scores are generated for each domain. A higher score indicates a better Performance. | 12 weeks |
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