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2026-05-07 00:00 China Clinical Launch & Registration Translated from EN

Xuzhou Rehabilitation Hospital Completes Stroke BCI Trial With Modified Constraint Therapy

Summary A trial at Xuzhou Rehabilitation Hospital Affiliated to Xuzhou Medical University paired a motor imagery brain-computer interface with modified constraint-induced movement therapy to restore upper-limb function after stroke. The hospital is a rehabilitation specialty facility affiliated with Xuzhou Medical University, and the combined approach is meant to test whether a BCI adds benefit on top of established rehabilitation training. It planned 40 participants, 20 in the combined group and 20 in the control group, with the first patient enrolled on December 24, 2025; the registry now lists the study as completed. The primary endpoint is the Fugl-Meyer Assessment for Upper Extremity, with the Wolf Motor Function Test and modified Barthel Index as secondary measures. Funding comes from the New Round of Xuzhou "Pengcheng Talent Program" — High-level Healthcare Talent Recruitment and Development Project, project number 2025TD14. No results are posted, so whether the combined approach beats constraint therapy alone remains unknown.
Why it matters The trial layers a motor imagery BCI on top of modified constraint-induced movement therapy, an established stroke rehabilitation method, to test whether the combination adds functional gain over constraint therapy alone. The first patient was enrolled in December 2025 and the registry now shows the study completed, meaning data collection has finished but results are not posted. For patients and rehabilitation clinicians, the number that matters is the Fugl-Meyer gap between the combined and control groups, not the hardware.

BCIwiki (bciwiki.com) — Xuzhou Rehabilitation Hospital Affiliated to Xuzhou Medical University has completed a trial of a motor imagery brain-computer interface combined with modified constraint-induced movement therapy for upper-limb function in stroke patients, according to a registration at the Chinese Clinical Trial Registry. The trial, registration number ChiCTR2600124103, was registered on May 7, 2026, and its recruitment status is listed as completed. It is an interventional, parallel-design study that planned to enroll 40 participants, 20 in the combined group and 20 in the control group. The first patient was enrolled on December 24, 2025, and the registry record was last updated on May 11, 2026.

Eligible patients were 18 to 75 years old, had a first-ever stroke, a unilateral lesion with disease duration under 6 months, and stable vital signs. They also had to meet the training criteria for modified constraint-induced movement therapy, including active wrist extension of the affected arm above 20 degrees, active extension of the thumb and at least 2 additional fingers above 10 degrees at the metacarpophalangeal and interphalangeal joints, performed at least 3 times per minute. Exclusions included traumatic brain injury, progressive stroke or subarachnoid hemorrhage with unstable clinical status, severe cardiac, hepatic, pulmonary or renal insufficiency, implanted electronic devices or metallic implants, a personal or family history of epilepsy, and severe pain or sensory impairment affecting the hemiplegic limb.

The combined group received the brain-computer interface plus modified constraint-induced movement therapy, while the control group received modified constraint-induced movement therapy alone. The primary outcome is the Fugl-Meyer Assessment for Upper Extremity; secondary outcomes are the Wolf Motor Function Test and the modified Barthel Index. Funding comes from the New Round of Xuzhou "Pengcheng Talent Program" — High-level Healthcare Talent Recruitment and Development Project, project number 2025TD14. The registry page contains only bibliographic and design fields, with no results data, device model or actual enrollment number.

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