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An exploratory study on the cardiopulmonary fitness assessment of bedridden stroke patients using a rehabilitation robot in bed

An exploratory study on the cardiopulmonary fitness assessment of bedridden stroke patients using a rehabilitation robot in bed

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047814
Enrollment
Unknown
Registered
2021-06-27
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

Gold Standard:Cardiopulmonary exercise test on backrest power bicycle.
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Sponsors

The First Affiliated Hospital of Shenzhen University, Shenzhen Second People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of cerebral hemorrhage or cerebral infarction; 2. Aged 18 to 65 years; 3. The vital signs are stable, and the onset time is within 12 months; 4.mRS grade 3-5; 5. Can complete the active treadmill action; 6. Cooperation degree S5Q>=3 points, able to understand and actively participate in assessment and training programs; 7. Patients or their families signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Progressive stroke; acute phase of stroke; transient ischemic attack; patients with a history of brain trauma, encephalitis, tuberculous meningitis and other brain parenchyma and central nervous system involvement; 2. Acute coronary syndrome, decompensated heart failure, uncontrolled severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, etc.) or high-grade atrioventricular block, severe heart valve disease, hypertrophic Obstructive cardiomyopathy, active myocarditis, pericarditis and other serious heart diseases; 3. Patients with severe hepatic and renal insufficiency, including glomerular filtration rate GFR=200U/L, or aspartate aminotransferase AST>=200U/L; 4. Patients with other serious diseases, such as malignant tumors, end-stage chronic kidney disease, mental disorders, severe malnutrition, etc.; 5. Those with unhealed lower extremity fractures and severe osteoporosis; those with high muscle tension and Ashworth grade 2-4; 6. Untreated deep vein thrombosis of lower extremities; 7. Pregnant or lactating women; 8. Participated in other clinical trials of drugs or medical devices during the same period; 9. The MMSE scale of patients with cognitive impairment is less than or equal to 17 points.

Design outcomes

Primary

MeasureTime frame
peak oxygen uptake;Anaerobic threshold (AT);

Secondary

MeasureTime frame
Respiratory exchange ratio (RER);Heart rate reserve (HRR);Stroke volume (SV);Cardiac output (CO);ST-T section;rating of perceived exertion (RPE);

Countries

China

Contacts

Public ContactWang Yulong

The First Affiliated Hospital of Shenzhen University

ylwang668@163.com+86 13923448395

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026