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Completed

NCT Number: NCT05807230

Three-level Network Rehabilitation Model

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Primary Medical Care Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First People's Hospital of Huzhou City

Huzhou, Zhejiang, 313000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Three-level network rehabilitation services within the medical alliance

Behavioral

Data of all levels of medical and health institutions in Huzhou region are shared, and advanced rehabilitation technologies are passed down from senior hospitals to grassroots medical institutions. Grassroots medical institutions to patients home for 3 months of rehabilitation training.

Primary outcomes

  1. 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.

  2. 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)

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Huzhou

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2023
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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