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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: "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.
Behavioral: Instructional manuals and exercise 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.
Behavioral: Instructional manuals and exercise videos
Postoperative shoulder and neck rehabilitation instructional manuals and exercise videos for home-based training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pai Pang

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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