Clinical trial · Interventional
Normative Ranges of Lingual Strength and Endurance and the Impact of the IOPI Lingual Strength Trainer on Quantitative Functional Outcomes and Patient-Reported Outcomes After Partial Glossectomy or Hemiglossectomy for Oral Tongue Cancer, An Unblinded: Randomized Pilot Study
NCT07124520CI-TRIAL-00116311recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to learn more about tongue strength and endurance by using the Iowa Oral Performance Instrument (IOPI). The IOPI is a device that measures tongue pressure.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tongue Cancer | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iowa Oral Performance Instrument (IOPI) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Standard of care plus intervention with the Iowa Oral Performance Instrument /IOPI. Randomization will be stratified by partial glossectomy versus hemiglossectomy.
- interventionNames
- Device: Iowa Oral Performance Instrument (IOPI)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Participants will receive standard of care. Randomization will be stratified by partial glossectomy versus hemiglossectomy.
Primary outcomes (2)
- measure
- Tongue strength as measured by Iowa Oral Performance Instrument/IOPI
- timeFrame
- Up to 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years old * Scheduled to undergo primary surgery for oral tongue cancer (glossectomy types 1 to 3) using any type of closure or reconstruction Exclusion Criteria: * Previous radiation therapy to the oral cavity or head and neck * Previous surgery for oral cavity cancer * Recurrent oral cavity cancer * Surgical requirement of extension to involve bone (mandible resection) * Subtotal or total glossectomy * Feeding tube dependance prior to surgery
References
Publications (0)
Data not yet available
No reference posted for this study.