Early and Systematic Shoulder Rehabilitation Following Cervical Lymph Node Dissection
RESYSTE
1 other identifier
interventional
120
1 country
1
Brief Summary
A prospective, monocentric, controlled, randomized study of systematic early shoulder rehabilitation following cervical lymph node dissection for the prevention and treatment of shoulder dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedStudy Start
First participant enrolled
July 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2023
CompletedJanuary 24, 2024
January 1, 2024
4.4 years
March 8, 2019
January 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)
The total score is reported. The score is between 0 and 100. The higher the score, the higher the disability.
6 months postoperatively (M6)
Secondary Outcomes (8)
Disabilities of Shoulder, Arm and Hand Questionnaire (DASH)
3 and 12 months postoperatively (M3 and M12)
visual analog score for pain (M3, M6 and M12)
3, 6 and 12 months postoperatively (M3, M6 and M12)
goniometric measurement of flexion and abduction of the shoulder
3, 6 and 12 months postoperatively (M3, M6 and M12)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
3, 6 and 12 months postoperatively (M3, M6 and M12)
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
3, 6 and 12 months postoperatively (M3, M6 and M12)
- +3 more secondary outcomes
Study Arms (2)
systematic early rehabilitation
EXPERIMENTALsystematic early rehabilitation
without systematic rehabilitation
NO INTERVENTIONwithout systematic rehabilitation
Interventions
3 sessions of shoulder rehabilitation per week for 3 months (36 sessions)
Eligibility Criteria
You may qualify if:
- Proficiency in the oral and written French language
- unilateral or bilateral cervical lymph node dissection preserving the accessory spinal nerve
- Karnofsky index ≥ 80%
- Age ≥ 18 years
You may not qualify if:
- cognitive disorders
- predictable difficulties in compliance with treatment and/or follow-up
- pre-existing pathology involving shoulder and its mobility, independent of head and neck cancer
- comorbidity preventing rehabilitation of the shoulder
- time to start rehabilitation after 6 weeks postoperatively
- pregnant women
- minors
- majors under guardianship
- refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nantes University Hospital
Nantes, 44093, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2019
First Posted
May 23, 2019
Study Start
July 2, 2019
Primary Completion
November 16, 2023
Study Completion
November 16, 2023
Last Updated
January 24, 2024
Record last verified: 2024-01