Three-level Network Rehabilitation Model

Not Applicable

Completed

• Conditions: Stroke; Primary Medical Care
• Interventions: Behavioral: Three-level network rehabilitation services within the medical alliance

• Registration Number: NCT05807230
• Lead Sponsor: The First People's Hospital of Huzhou

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional therapy and three-level network rehabilitation services	Three-level network rehabilitation services within the medical alliance	Three months after received conventional three-level rehabilitation treatment, conventional Chinese medicine and acupuncture treatment, patients continued to receive three-level network rehabilitation services within the medical alliance.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer motor score	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	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	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	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).

Trial Locations

Locations (1)

The First People's Hospital of Huzhou City; 🇨🇳 Huzhou, Zhejiang, China