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

Not Applicable

Recruiting

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

• Registration Number: NCT06153992
• Lead Sponsor: Ran Shi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-04
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-12-01
• Last Update Posted: 2023-12-01
• Study Start: 2024-01-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Intelligent Multi Joint Isokinetic; 🇨🇳 Jinan, Shandong, China