Three-level Network Rehabilitation Model

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05807230
• Other study ID #: Wenming Feng
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: The First People's Hospital of Huzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary Medical Care
• Stroke

Intervention

Behavioral:
• Three-level network rehabilitation services within the medical alliance
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.

Locations

Country	Name	City	State
China	The First People's Hospital of Huzhou City	Huzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Huzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer motor score	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.	Assessment was made after 3 months of intervention
Primary	The Berg balance scale	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)	Assessment was made after 3 months of intervention
Primary	National Institute of Health stroke scale	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).	Assessment was made after 3 months of intervention
Primary	Barthel index	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).	Assessment was made after 3 months of intervention