Tumor of Spinal CordNCT04968730
Establishment and Application of Early Postoperative Activity Plan for Patients After Hemi-laminectomy for Lumbar Spinal Tumor Resection
A study testing Postoperative rehabilitation nursing in people with Tumor of Spinal Cord, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Objective to construct the related early activity program for patients with lumbar intraspinal tumor after hemilaminectomy, and evaluate the postoperative limb function exercise according to the content of the program. Read more about this study
- Who is it for?
- Ages 14 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor of Spinal Cord
- What is being tested?
- Postoperative rehabilitation nursing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2021to 31 Dec 2022
- 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 14 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with primary benign intraspinal tumors at the level of L1-L5 who underwent semi laminectomy;
- The age of the patients ranged from 14 to 80 years old;
- The GCS score was 15 points, and the lower limb muscle strength was more than or equal to grade 3 before operation; The patients agreed to the operation and were willing to accept and cooperate with the concept of early rehabilitation nursing and related measures;
Who cannot join
- patients with rapid development of disease, difficult to exclude malignant tumors, and non neoplastic lesions in spine or spinal canal;
- Have a history of severe hypertension, heart disease or other mental illness;
- Patients with major organ damage or coagulation dysfunction;
- The patients and their family members had poor communication and compliance;
- There are factors that may progress or worsen the patient's condition (such as uncontrolled infection, severe respiratory disease, pulmonary infection, etc.);
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wangping Neurosurgical
Hangzhou, 310000
ping wang, Bachelor, 13588203480, tai3480@dingtalk.com
About this study
Objective to construct the related early activity program for patients with lumbar intraspinal tumor after hemilaminectomy, and evaluate the postoperative limb function exercise according to the content of the program. In order to improve the self-care ability and quality of life of patients, reduce postoperative complications, shorten the average length of stay, reduce hospitalization expenses and improve patient satisfaction.
Objective to evaluate the efficacy and safety of establishing early activity program after hemilaminectomy for patients with lumbar intraspinal tumors
- Conditions
- Tumor of Spinal Cord
- Being tested
- Postoperative rehabilitation nursing
- Keywords
- early rehabilitation training
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative rehabilitation nursingOther
Make postoperative rehabilitation plan according to nursing experience for group A Develop rehabilitation process according to the activity plan for group B
| Study group | Role | What they receive |
|---|---|---|
| control group A | Placebo comparator | routine nursing after operation Receives: Other: Postoperative rehabilitation nursing |
| intervention group B | Experimental | Nursing care after operation with stage intervention Receives: Other: Postoperative rehabilitation nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient rehabilitation and leave hospital
The whole clinical courses were strictly controlled in quality so as to compare the average length of stay (days) in the two groups.
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start11 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor of Spinal CordStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The routine group was given routine nursing, and the control group was given early rehabilitation nursing
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968730
- Sponsor's protocol ID
- 2021-0116
- Status last verified
- May 2021
- First submitted
- 1 Jun 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Application of Early Postoperative Activity Plan for Patients After Hemi-laminectomy for Lumbar Spinal Tumor Resection
- ClinicalTrials.gov ID
- NCT04968730
- Acronym / sponsor ID
- 2021-0116
- Conditions
- Tumor of Spinal Cord
- Keywords
- early rehabilitation training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Jul 2021 (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.
Objective to construct the related early activity program for patients with lumbar intraspinal tumor after hemilaminectomy, and evaluate the postoperative limb function exercise according to the content of the program. In order to improve the self-care ability and quality of life of patients, reduce postoperative complications, shorten the average length of stay, reduce hospitalization expenses and improve patient satisfaction.
Objective to evaluate the efficacy and safety of establishing early activity program after hemilaminectomy for patients with lumbar intraspinal tumors
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The routine group was given routine nursing, and the control group was given early rehabilitation nursing
| Arm | Type | Receives |
|---|---|---|
| control group A | Placebo comparator | Other: Postoperative rehabilitation nursingroutine nursing after operation |
| intervention group B | Experimental | Other: Postoperative rehabilitation nursingNursing care after operation with stage intervention |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with primary benign intraspinal tumors at the level of L1-L5 who underwent semi laminectomy;
- The age of the patients ranged from 14 to 80 years old;
- The GCS score was 15 points, and the lower limb muscle strength was more than or equal to grade 3 before operation; The patients agreed to the operation and were willing to accept and cooperate with the concept of early rehabilitation nursing and related measures;
Key exclusion criteria (5 listed)
- patients with rapid development of disease, difficult to exclude malignant tumors, and non neoplastic lesions in spine or spinal canal;
- Have a history of severe hypertension, heart disease or other mental illness;
- Patients with major organ damage or coagulation dysfunction;
- The patients and their family members had poor communication and compliance;
- There are factors that may progress or worsen the patient's condition (such as uncontrolled infection, severe respiratory disease, pulmonary infection, etc.);
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 |
|---|---|---|
| Postoperative rehabilitation nursingMake postoperative rehabilitation plan according to nursing experience for group A Develop rehabilitation process according to the activity plan for group B | Other | control group A, intervention group B |
Primary outcome
Patient rehabilitation and leave hospital
Time frame: up to two years
The whole clinical courses were strictly controlled in quality so as to compare the average length of stay (days) in the two groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative rehabilitation nursing in people with Tumor of Spinal Cord, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 5 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 20 Jul 2021. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rehabilitation and leave hospital (time frame: up to two years). 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 20 Jul 2021.