StrokeNCT06153992
Clinical Application of Portable Intelligent Multi Joint Isokinetic Training and Evaluation System Technology
A study testing Intelligent portable isokinetic muscle strength test training, isokinetic muscle strength test training and without test training in people with Stroke and Hemiplegia, run by Ran Shi at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Hemiplegia, Rehabilitation; Tobacco Use
- What is being tested?
- Intelligent portable isokinetic muscle strength test training, isokinetic muscle strength test training and without test training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Intelligent Multi Joint Isokinetic
Jinan, Shandong, 250014
docter, 15866616997, 17686689905@126.com
About this study
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.
- Conditions
- Stroke, Hemiplegia, Rehabilitation; Tobacco Use, Physical Disability
- Being tested
- Intelligent portable isokinetic muscle strength test training, isokinetic muscle strength test training, without test training
- Medical subject headings
- Stroke, Hemiplegia, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent portable isokinetic muscle strength test trainingDevice
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 trainingDevice
The isokinetic training of knee flexors and extensors was carried out by using isokinetic muscle strength test training system
without test trainingOther
Treatment was performed without using any isokinetic muscle strength test training system
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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) . Receives: Other: without test training |
| Traditional isokinetic treatment group | Active comparator | 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. Receives: Device: isokinetic muscle strength test training; Other: without test training |
| Intelligent isokinetic treatment group | Experimental | 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. Receives: Device: Intelligent portable isokinetic muscle strength test training; Other: without test training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 1 month
Measured peak moment
Peak moment of knee joint at 60 °/s angular velocity in Nm
Measured: up to 1 month
Secondary outcomes (1)
Satisfaction questionnaire survey
Survey of patients' comfort and satisfaction with the treatment process and effectiveness(score 0-100 points).
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ran Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ran Shi, Qianfoshan Hospital
- Investigators
- Sanyuan Hu, doctor, Study chair, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153992
- Sponsor's protocol ID
- 2021004
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Portable Intelligent Multi Joint Isokinetic Training and Evaluation System Technology
- ClinicalTrials.gov ID
- NCT06153992
- Acronym / sponsor ID
- 2021004
- Conditions
- Stroke, Hemiplegia, Rehabilitation; Tobacco Use, Physical Disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ran ShiUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: without test trainingThe 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) . |
| Traditional isokinetic treatment group | Active comparator | Device: isokinetic muscle strength test training, Other: without test trainingThe treatment machine adopts the traditional isokinetic training machine, the treatment items and the treatment parameters are the same as the intelligent isokinetic treatment group. |
| Intelligent isokinetic treatment group | Experimental | Device: Intelligent portable isokinetic muscle strength test training, Other: without test trainingIn 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Vital signs are unstable
- Severe cognitive, visual and hearing impairment
- Orthopaedic disease
- Muscle pain lower extremity
- Congenital disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent portable isokinetic muscle strength test trainingThe isokinetic training of knee flexors and extensors was carried out by using intelligent portable isokinetic muscle strength test training system | Device | Intelligent isokinetic treatment group |
| isokinetic muscle strength test trainingThe isokinetic training of knee flexors and extensors was carried out by using isokinetic muscle strength test training system | Device | Traditional isokinetic treatment group |
| without test trainingTreatment was performed without using any isokinetic muscle strength test training system | Other | Control group, Intelligent isokinetic treatment group, Traditional isokinetic treatment group |
Primary outcome
Body function
Time frame: 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
Time frame: up to 1 month
Peak moment of knee joint at 60 °/s angular velocity in Nm
1 secondary outcome
Satisfaction questionnaire survey
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanyuan Hu, doctor study chair
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent portable isokinetic muscle strength test training, isokinetic muscle strength test training and without test training in people with Stroke and Hemiplegia, run by Ran Shi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran Shi, doctor (17686689905, zm17686689905@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body function (time frame: up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.