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The clinical effect of combined Pre-operative Intensive sensorimotor Rehabilitation Therapy for chronic stroke patients before the C7-C7 nerve cross transfer: a randomized controlled trial

The clinical effect of combined Pre-operative Intensive sensorimotor Rehabilitation Therapy for chronic stroke patients before the C7-C7 nerve cross transfer: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027688
Enrollment
Unknown
Registered
2019-11-23
Start date
2019-11-22
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

Stroke

Interventions

1:Pre-operative Intensive sensorimotor Rehabilitation Therapy
2:Conventional Rehabilitation Therapy

Sponsors

Hand Surgery Department,Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) spastic hemiplegia caused by stroke (including hemorrhagic and ischemic), including but not limited to those with difficulty in opening hands; (2) the total score of Fugl Meyer's upper extremity movement scale 15 to 35; (3) aged 40 to 70 years; (4) after stroke onset, it is more than or equal to 1 year. After stroke onset, the patients have received regular rehabilitation treatment in hospital for at least 6 months, and the recovery of upper limb function has entered the platform stage. In recent 3 months, no intensive rehabilitation treatment for upper limb has been carried out in the hospital, that is, if the upper limb rehabilitation treatment has been carried out in the hospital in recent 3 months, the average treatment time should be less than 1 hour per week; (5) MRI confirmed that the damage of central nervous system only involved one side of cerebral hemisphere; (6) patient and his/her family members have the intention to improve the function of the affected upper limb, and have the intention to do the left and right seven neck cross displacement, and there is no surgical contraindication; (7) consciousness, intelligence and language, be able to fully understand and follow the doctor's treatment instructions, and sign the informed consent. All the above conditions shall be met, and the first, second and fifth points shall be diagnosed by two specialists or above.

Exclusion criteria

Exclusion criteria: (1) any subject with recurrent acute cerebral infarction or cerebral hemorrhage; (2) subjects with metal retention in the head after cranioplasty; (3) subjects with stiff joints; (4) serious fixation contracture or joint deformity; (5) mental and language disorders, MMSE score less than 27; (6) the life expectancy of subjects is less than 15 months; (7) those who have participated in clinical trials of other drugs or medical devices before being selected but failed to reach the time limit of main research end point; (8) the researcher judged that the subjects' compliance was poor and could not complete the clinical trial as required; (9) patient and his/her family members refused to participate in the clinical trial; (10) Pregnancy.

Design outcomes

Primary

MeasureTime frame
Changes in total score of fugl-meyer scale;

Countries

China

Contacts

Public ContactWendong Xu

Huashan Hospital, Fudan University

wendongxu@fudan.edu.cn+86 13501961024

Outcome results

None listed

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