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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153992
• Other study ID #: 2021004
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 20, 2024

Study information

• Verified date: November 2023
• Source: Qianfoshan Hospital
• Contact: Ran Shi, doctor
• Phone: 17686689905
• Email: zm17686689905[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 20, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Physical Disability
• Rehabilitation; Tobacco Use
• Stroke

Intervention

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

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

Locations

Country	Name	City	State
China	Intelligent Multi Joint Isokinetic	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Ran Shi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Measured peak moment	Peak moment of knee joint at 60 °/s angular velocity in Nm	up to 1 month
Secondary	Satisfaction questionnaire survey	Survey of patients' comfort and satisfaction with the treatment process and effectiveness(score 0-100 points).	up to 1 month