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Three-level Network Rehabilitation Model

Primary Purpose

Stroke, Primary Medical Care

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Three-level network rehabilitation services within the medical alliance
Sponsored by
The First People's Hospital of Huzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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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.

Sites / Locations

  • The First People's Hospital of Huzhou City

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional therapy: three-level rehabilitation treatment, Chinese medicine and acupuncture

Conventional therapy and three-level network rehabilitation services

Arm Description

Patients received conventional three-level rehabilitation treatment, conventional Chinese medicine and acupuncture treatment.

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.

Outcomes

Primary Outcome Measures

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.
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)
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).
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).

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
March 28, 2023
Sponsor
The First People's Hospital of Huzhou
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1. Study Identification

Unique Protocol Identification Number
NCT05807230
Brief Title
Three-level Network Rehabilitation Model
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First People's Hospital of Huzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Primary Medical Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional therapy: three-level rehabilitation treatment, Chinese medicine and acupuncture
Arm Type
No Intervention
Arm Description
Patients received conventional three-level rehabilitation treatment, conventional Chinese medicine and acupuncture treatment.
Arm Title
Conventional therapy and three-level network rehabilitation services
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Three-level network rehabilitation services within the medical alliance
Intervention Description
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 Outcome Measure Information:
Title
Fugl-Meyer motor score
Description
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.
Time Frame
Assessment was made after 3 months of intervention
Title
The Berg balance scale
Description
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)
Time Frame
Assessment was made after 3 months of intervention
Title
National Institute of Health stroke scale
Description
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).
Time Frame
Assessment was made after 3 months of intervention
Title
Barthel index
Description
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).
Time Frame
Assessment was made after 3 months of intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The First People's Hospital of Huzhou City
City
Huzhou
State/Province
Zhejiang
ZIP/Postal Code
313000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Three-level Network Rehabilitation Model

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