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

Sponsor
Ran Shi (Other)
Overall Status
Recruiting
CT.gov ID
NCT06153992
Collaborator
(none)
90
1
3
11.6
7.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intelligent portable isokinetic muscle strength test training
  • Device: isokinetic muscle strength test training
  • Other: without test training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Clinical Application of Portable Intelligent Multi Joint Isokinetic Training and Evaluation System Technology
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 20, 2024

Arms and Interventions

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.

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

Other: without test training
Treatment was performed without using any 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.

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

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

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. Measured peak moment [up to 1 month]

    Peak moment of knee joint at 60 °/s angular velocity in Nm

Secondary Outcome Measures

  1. Satisfaction questionnaire survey [up to 1 month]

    Survey of patients' comfort and satisfaction with the treatment process and effectiveness(score 0-100 points).

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Intelligent Multi Joint Isokinetic Jinan Shandong China 250014

Sponsors and Collaborators

  • Ran Shi

Investigators

  • Study Chair: Sanyuan Hu, doctor, Qianfoshan Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Ran Shi, doctor, Qianfoshan Hospital
ClinicalTrials.gov Identifier:
NCT06153992
Other Study ID Numbers:
  • 2021004
First Posted:
Dec 1, 2023
Last Update Posted:
Dec 1, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2023