Three-level Network Rehabilitation Model

NCT05807230 | Completed

• 1 other identifier: Wenming Feng
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Primary Medical Care

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

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

NO INTERVENTION

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

Conventional therapy and three-level network rehabilitation services

EXPERIMENTAL

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.

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

Interventions

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.

Conventional therapy and three-level network rehabilitation services

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Huzhou: lead

Study Sites (1)

The First People's Hospital of Huzhou City

Huzhou, Zhejiang, 313000, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 11, 2023
• Study Start: January 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)