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Clinical Trials/NCT05807230
NCT05807230
Completed
N/A

Stroke Rehabilitation System of Oriental and Western Medicine Based on Three-level Network Rehabilitation Model Under the Background of Medical Alliance in Huzhou

The First People's Hospital of Huzhou1 site in 1 country90 target enrollmentJanuary 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
The First People's Hospital of Huzhou
Enrollment
90
Locations
1
Primary Endpoint
Fugl-Meyer motor score
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The objective of this clinical trial was to compare the effects of different interventions on the recovery of stroke patients. The main question it aims to answer are: whether the intervention mode of integrated Chinese and western medicine is more valuable to implement.

Researchers randomly assigned 90 patients to either group A or Group B, 45 in each group. Group A adopted the conventional three-level rehabilitation model; Group B adopted the three-level network rehabilitation model under the medical alliance for rehabilitation treatment with combination of Chinese and Western medicine. Fugl-Meyer motor score was used to assess the patient's motor ability, Berg balance scale was used to assess the patient's balance ability, National Institute of Health stroke scale was used to assess the patient's neurological function, and modified Barthel index was used to assess the patient's ability of daily living.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The First People's Hospital of Huzhou
Responsible Party
Principal Investigator
Principal Investigator

Wenming Feng

President

The First People's Hospital of Huzhou

Eligibility Criteria

Inclusion Criteria

  • Patients whose primary disease is stroke, whose diagnosis conforms to the "Chinese and Western Medicine Emergency Diagnosis and Treatment Expert Consensus for Acute Ischemic Stroke";
  • confirmed by imaging MRI or CT;
  • hemiplegia symptoms; clear-headed, able to actively cooperate with the doctor's treatment, the basic vital signs are stable, and the neurological signs basically do not develop.

Exclusion Criteria

  • Patients with lower extremity joint disease, osteoarthritis or ankle joint injury in the past;
  • patients with lumbar spine or sacral spinal stenosis in the past;
  • patients with previous epilepsy;
  • patients with previous history of stroke;
  • patients with heart and renal failure;
  • Patients who cannot cooperate with treatment.

Outcomes

Primary Outcomes

Fugl-Meyer motor score

Time Frame: Assessment was made after 3 months of intervention

This scale evaluates the patient's motor ability, including 7 major items and 17 sub-items such as reflex activity, cooperative movement, coordination ability, speed, etc. each item is 0-2 points, a total of 34 points, the higher the score, the better the exercise ability.

The Berg balance scale

Time Frame: Assessment was made after 3 months of intervention

This scale evaluate the balance ability of the patients, and the balance ability of the two groups of patients before and after 6 months of treatment was scored, including standing, sitting, standing-to-sit transfer, bed-chair transfer, and turning around, totaling 14 items, totaling 56 score (the higher the score, the better the balance ability)

National Institute of Health stroke scale

Time Frame: Assessment was made after 3 months of intervention

This scale evaluate the neurological function of the two groups before treatment and 4 weeks after treatment, including consciousness, eye movement, visual field, facial paralysis, limb movement, limb coordination, sensation, vision, hearing and touch, totaling 11 items, totaling 42 points (the higher the score, the more serious the neurological deficit of the patient).

Barthel index

Time Frame: Assessment was made after 3 months of intervention

This scale evaluate the daily living ability of the two groups of patients before treatment and 4 weeks after treatment, including eating, bathing, grooming, dressing, control of urination, toileting, and seat transfer.10 items such as walking and going up and down stairs, each item is scored from 0 to 10,with a total of 100 points (the higher the score, the stronger the patient's daily living ability).

Study Sites (1)

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