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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Hemiplegia; Physical Disability; Rehabilitation; Tobacco Use
• Intervention / Treatment: Other: without test training; Device: isokinetic muscle strength test training; Device: Intelligent portable isokinetic muscle strength test training

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ran Shi, doctor; Phone Number: 17686689905; Email: zm17686689905@126.com
• Study Contact Backup: Name: May Zheng, doctor; Phone Number: 13658602285; Email: zm17686689905@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • Intelligent Multi Joint Isokinetic
      • Contact: docter; Phone Number: 15866616997; Email: 17686689905@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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) .	Other: without test training; Treatment was performed without using any isokinetic muscle strength test training system
Active Comparator: 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.	Other: without test training; Treatment was performed without using any isokinetic muscle strength test training system; 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
Experimental: 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.	Other: without test training; Treatment was performed without using any isokinetic muscle strength test training system; Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body function	Evaluate lower limb motor function using the Fugl Meyer method (total lower limb motor score 0-34 points, total balance score 0-14 points).	up to 1 month
Measured peak moment	Peak moment of knee joint at 60 °/s angular velocity in Nm	up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction questionnaire survey	Survey of patients' comfort and satisfaction with the treatment process and effectiveness(score 0-100 points).	up to 1 month

Collaborators and Investigators

• Sponsor: Ran Shi
• Investigators: Study Chair: Sanyuan Hu, doctor, Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Estimated): December 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: 2021004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No