Clinical Application of Portable Intelligent Multi Joint Isokinetic Training and Evaluation System Technology

NCT ID: NCT06153992

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-20

Brief Summary

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The goal of this clinical trial is to compare in describeparticipant population. The main question it aims to answer is:By using intelligent portable isokinetic tester and traditional isokinetic tester, isokinetic knee flexor and extensor muscles of stroke patients with hemiplegia were trained respectively, so as to observe and compare the effects of the two treatment methods. In addition, the therapeutic effect of the above two treatments was compared with that of exercise therapy alone. Participants will be divided into three groups: control group, intelligent isokinetic treatment group, and traditional isokinetic treatment group. Participants of both the control group and the two treatment groups received exercise therapy. On the basis of exercise therapy, participants of the intelligent isokinetic treatment group used the intelligent portable isokinetic tester to train the affected knee flexion and extensor muscle, while the participants of traditional isokinetic treatment group used the intelligent portable isokinetic tester to train the affected knee flexion and extensor muscle.

Detailed Description

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Conditions

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Stroke Hemiplegia Rehabilitation; Tobacco Use Physical Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control group

The control group received exercise therapy (once a day, 40min/ times, 5 times/week), occupational therapy (once a day, 30min/ times, 5 times/week), low-frequency electricity (once a day, 20min/ times, 5 times/week), acupuncture therapy (once a day, 20min/ times, 5 times/week) .

Group Type ACTIVE_COMPARATOR

without test training

Intervention Type OTHER

Treatment was performed without using any isokinetic muscle strength test training system

Traditional isokinetic treatment group

The treatment machine adopts the traditional isokinetic training machine, the treatment items and the treatment parameters are the same as the intelligent isokinetic treatment group.

Group Type ACTIVE_COMPARATOR

isokinetic muscle strength test training

Intervention Type DEVICE

The isokinetic training of knee flexors and extensors was carried out by using isokinetic muscle strength test training system

without test training

Intervention Type OTHER

Treatment was performed without using any isokinetic muscle strength test training system

Intelligent isokinetic treatment group

In the intelligent isokinetic treatment group, isokinetic muscle strength training of hemiplegic lower limb flexion muscle group and knee extension muscle group was added to the treatment of the control group.

Intelligent isokinetic treatment to increase the above treatment hemiplegic lower limb flexion, knee extension muscle isokinetic strength training. The patient's seat back was adjusted to 85° and fixed with a belt and shoulder cross-strap. The thigh of the subject was fixed with a nylon buckle, the lateral condyle of the femur was the axis, the lever arm length was scale 12, and the distal leg was fixed above the ankle. Passive joint activities were performed on the knee and ankle before training. Avoid joint damage and perform three low-resistance warm-up exercises. Choose 60°/s, 90°/s, 120°/s angular speed isokinetic training according to the patient's specific conditions. Each angular speed training is 10 times, the interval rest is 15s.ect.

Group Type EXPERIMENTAL

Intelligent portable isokinetic muscle strength test training

Intervention Type DEVICE

The isokinetic training of knee flexors and extensors was carried out by using intelligent portable isokinetic muscle strength test training system

without test training

Intervention Type OTHER

Treatment was performed without using any isokinetic muscle strength test training system

Interventions

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Intelligent portable isokinetic muscle strength test training

The isokinetic training of knee flexors and extensors was carried out by using intelligent portable isokinetic muscle strength test training system

Intervention Type DEVICE

isokinetic muscle strength test training

The isokinetic training of knee flexors and extensors was carried out by using isokinetic muscle strength test training system

Intervention Type DEVICE

without test training

Treatment was performed without using any isokinetic muscle strength test training system

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Cerebral apoplexy's Disease
* Confirmed by CT or MR Examination of the head
* First onset, duration ≤1 month
* The lower extremity of the hemiplegic limb was above Brunnstrom stage III
* Must be able to sign the informed consent form

Exclusion Criteria

* Vital signs are unstable
* Severe cognitive, visual and hearing impairment
* Orthopaedic disease
* Muscle pain lower extremity
* Congenital disease
* History of other encephalopathy
* History of mental illness
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ran Shi

OTHER

Sponsor Role lead

Responsible Party

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Ran Shi

doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sanyuan Hu, doctor

Role: STUDY_CHAIR

Qianfoshan Hospital

Locations

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Intelligent Multi Joint Isokinetic

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ran Shi, doctor

Role: CONTACT

Phone: 17686689905

Email: [email protected]

May Zheng, doctor

Role: CONTACT

Phone: 13658602285

Email: [email protected]

Facility Contacts

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docter

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2021004

Identifier Type: -

Identifier Source: org_study_id