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Study on Upper Limb Functional Outcomes and Mechanisms Under Different Hyperbaric Oxygen Therapy Strategies After Stroke: An Open-Label Superiority Randomized Controlled Trial

Study on Upper Limb Functional Outcomes and Mechanisms Under Different Hyperbaric Oxygen Therapy Strategies After Stroke: An Open-Label Superiority Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115548
Enrollment
Unknown
Registered
2025-12-29
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

stroke

Interventions

Low-Pressure Treatment Group:Conduct routine upper limb rehabilitation training + medical air pressure oxygen chamber (treatment pressure set at 1.6ATA, compression for 10 minutes, stable pressure oxy
High-Pressure Treatment Group:Undertake routine upper limb rehabilitation exercises + medical air pressure hyperbaric oxygen chamber (treatment pressure set at 2.2 ATA, pressurization for 15 minutes,
Control Group:Perform routine upper limb rehabilitation training + out-of-chamber oxygen therapy (using a mask for oxygen inhalation, with a medical oxygen concentration of over 99.5%, for 60 minutes

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University(Shenzhen)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for stroke (including cerebral hemorrhage and cerebral infarction) established by the Fourth National Cerebrovascular Disease Academic Conference; 2. First-time occurrence, and confirmed by head CT or MRI to be cerebral hemorrhage or cerebral infarction, with a disease course of 2 weeks to 6 months; 3. Age between 18 and 80 years old, including both 18 and 80 years old, with no gender restrictions; 4. A score of 18 or higher on the Montreal Cognitive Assessment (MoCA), capable of cooperating and completing the experiment; 5. Stable vital signs.

Exclusion criteria

Exclusion criteria: 1. There are contraindications to hyperbaric oxygen therapy: untreated pneumothorax, pulmonary bullae, open chest trauma, taking disulfiram or anticancer drugs, severe respiratory tract infections, severe bleeding tendencies, uncontrolled epilepsy, or high fever. 2. There are serious primary diseases such as malignant tumors, severe heart, liver, lung, kidney dysfunction, and endocrine, hematopoietic, and immune system disorders; 3. Severe mental illnesses that prevent understanding instructions and cooperation.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment of Upper Extremity, FMA-UE;

Secondary

MeasureTime frame
NlH Stroke Scale;Modified Barthel Index, MBI;Stroke-Specific Quality of Life Scale, SS-QOL;Recurrence rate of cerebrovascular events.;functional near - infrared spectroscopy;

Countries

China

Contacts

Public ContactQiang Lin

The Seventh Affiliated Hospital of Sun Yat-sen University(Shenzhen)

linqiang@sysush.com+86 189 2249 7674

Outcome results

None listed

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