- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07504809
Research on the Effectiveness of Remote Rehabilitation l for Shoulder and Neck Recovery in Oral Cancer Patients After Selective Neck Dissection
March 26, 2026 updated by: Pai Pang
Consecutive patients undergoing oral cancer treatment at the hospital were enrolled and randomly assigned to either a control group or an experimental group using a random number table.
The control group received standard postoperative rehabilitation, including instructional manuals and exercise videos, to ensure proper rehabilitation training and precautions after discharge.
Rehabilitation physicians assessed outcomes and provided guidance during follow-up visits.
The experimental group adopted the "Internet +" remote rehabilitation model.
Patients were instructed to download a rehabilitation follow-up app, which provided daily exercise reminders.
Patients logged their completed exercises and periodically recorded rehabilitation videos.
Rehabilitation physicians remotely evaluated and guided patients based on the submitted videos.
Shoulder and neck function were assessed using the Constant-Murley Shoulder Score and Neck Dissection Impairment Index (NDII) at preoperative, 10-day, 1-month, and 3-month postoperative intervals.
Study Overview
Status
Active, not recruiting
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110001
- .Department of Oromaxillofacial-Head and Neck Surgery, Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, China Medical University, Liaoning Provincial Key Laboratory of Oral Diseases, Shenyang, PR China.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Primary oral cancer patients with surgical indications who provided informed consent and underwent surgical treatment including neck dissection with spinal accessory nerve preservation.
- Able to understand and provide informed consent for rehabilitation training, cooperative with training and required follow-ups.
- No history of conditions affecting shoulder mobility, including scapulohumeral periarthritis, cervical spondylosis, myofascial pain syndrome, or rheumatic diseases.
Exclusion Criteria:
- Previous surgery or trauma in the neck and shoulder region, or prior neck lymph node dissection.
- Pre-existing shoulder and neck pain, abnormal bilateral shoulder and neck range of motion, or abnormal muscle strength.
- Severe systemic underlying diseases that prevent cooperation with examinations.
- Underwent radical neck dissection or received postoperative radiotherapy or chemotherapy that may affect shoulder and neck mobility.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group:Telerehabilitation
Patients received routine postoperative rehabilitation plus Internet-based telerehabilitation intervention, including regular exercise reminders, online training video submission, real-time feedback, and personalized remote guidance from medical staff.
|
Patients were instructed to download a rehabilitation follow-up app, which provided daily exercise reminders.
Patients logged their completed exercises and periodically recorded rehabilitation videos.
Rehabilitation physicians remotely evaluated and guided patients based on the submitted videos.
Postoperative shoulder and neck rehabilitation instructional manuals and exercise videos for home-based training.
|
|
Active Comparator: Control group: Standard postoperative rehabilitation
Patients received standard postoperative shoulder and neck rehabilitation guidance, including instructional manuals and exercise videos, with face-to-face evaluation and advice during follow-up visits.
|
Postoperative shoulder and neck rehabilitation instructional manuals and exercise videos for home-based training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Constant-Murley shoulder score at baseline, 10 days, 1 month, and 3 months
Time Frame: Baseline, 10 days, 1 month, 3 months
|
Shoulder function (pain, daily activity, range of motion, muscle strength) measured by the Constant-Murley score at baseline, 10 days, 1 month, and 3 months postoperatively
|
Baseline, 10 days, 1 month, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Dissection Impairment Index (NDII) score at baseline, 10 days, 1 month, and 3 months
Time Frame: Baseline, 10 days, 1 month, 3 months
|
Neck pain, stiffness, and quality of life assessed by the Neck Dissection Impairment Index (NDII) at baseline, 10 days, 1 month, and 3 months postoperatively
|
Baseline, 10 days, 1 month, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 28, 2025
Primary Completion (Estimated)
October 20, 2026
Study Completion (Estimated)
December 20, 2026
Study Registration Dates
First Submitted
March 16, 2026
First Submitted That Met QC Criteria
March 26, 2026
First Posted (Actual)
April 1, 2026
Study Record Updates
Last Update Posted (Actual)
April 1, 2026
Last Update Submitted That Met QC Criteria
March 26, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- K2024043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oral Cancer Patients After Selective Neck Dissection
-
Yonsei UniversityCompletedPatients Who Needs Sedation After Head & Neck SurgeryKorea, Republic of
-
Cairo UniversityRecruitingMaternal Complications After Oral Anticoagulation When Initiated Early and Late After Caesarean Section Done for Patients With Mechanical Heart Valve ProsthesisEgypt
-
University of ChileUniversidad de La FronteraCompletedOlder Adults | Oral Cancer | Oral Health Knowledge, Attitude and Practice Among PatientsChile
-
Matthew SpectorAxogen CorporationActive, not recruitingHead and Neck Cancer | Neck DissectionUnited States
-
McMaster UniversityNot yet recruitingHead and Neck Cancer | Nerve Injury | Neck DissectionCanada
-
Seoul National University HospitalCompletedPancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment
-
Anil ChaturvediNational Taiwan University HospitalRecruitingOral Cancer | Oral Cancer Screening | Oral PrecancerTaiwan
-
October 6 UniversityCompletedHead and Neck Cancer Patients Treated With RadiotherapyEgypt
-
University Medical Center GoettingenRecruitingHead & Neck Cancer | Dentist-Patient Relations | Oral Health Behavior Change | Oral Health Care | Dentist's RoleGermany
-
Shanghai Ninth People's Hospital Affiliated to...Not yet recruitingOral Squamous Cell Carcinoma | Neck Dissection
Clinical Trials on "Internet +" remote rehabilitation model
-
The First Affiliated Hospital of Guangzhou Medical...RecruitingRehabilitation | Postoperative Care | Randomized Controlled Trial (RCT) | Artificial Intelligence (Al)China
-
American Academy of PediatricsNational Institute on Drug Abuse (NIDA)Completed
-
China Cardiovascular AssociationPfizerUnknown
-
University of South FloridaPatient-Centered Outcomes Research InstituteCompleted
-
Endocrine Research SocietyCompletedType 2 Diabetes MellitusCanada
-
Endocrine Research SocietySuspendedType 2 Diabetes MellitusCanada
-
Endocrine Research SocietySuspendedType 2 Diabetes MellitusCanada
-
Yale UniversityPatient-Centered Outcomes Research InstituteRecruitingPostpartum HypertensionUnited States
-
Xingchen PengActive, not recruitingHead and Neck Cancer | Rehabilitation | PsychotherapyChina
-
Pontificia Universidad Catolica de ChileNational Fund for Research and Development in Health, Chile; Corporación Municipal...CompletedPrediabetic State | Glucose IntoleranceChile