ClinicalTrials.gg
TerminatedNCT06095011Updated Sep 23, 2026

Posture Correction in Cubital Tunnel Syndrome

An interventional study of UpRight Go in Cubital Tunnel Syndrome, sponsored by Yale University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Yale University · Not applicable, Interventional, and Supportive care

Why this study was terminated
lack of funding

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Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 12 studies in Cubital Tunnel Syndrome with a site in United States — 1 open to participants now, 2 under way, none of them phase 3. Cubital Tunnel Syndrome · United States.

Enrollment
6th of 10
6 · median 13
Started
2023
with 1 other
No phase
9 of 12
1 open now
Registered
10th of 12
by date

Among the 12 studies in Cubital Tunnel Syndrome with a site in United States, this one is the 6th largest by enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2023, is one of 9 with no phase, and was the 10th registered.

Cubital Tunnel Syndrome

35 studies on the registry are indexed under Cubital Tunnel Syndrome; 6 are open to participants now.

Browse Cubital Tunnel Syndrome studies →

Open to participants now

1 of the 12 studies in Cubital Tunnel Syndrome with a site in United States is open now. Recruiting first, the newest first:

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 3 Cubital Tunnel Syndrome studies recruiting now, 1 sets no upper age limit and 1 stops at 75 or younger; none take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The primary objective of this study is to determine whether the UpRight Go posture trainer reduces the symptoms of cubital tunnel syndrome in patients who have not had corrective surgery, as determined by improvements in VAS scores for pain, numbness, and weakness.

Read the detailed description

This is a randomized controlled, non-blinded trial. All patients who are eligible to participate and who consent to participate will be randomized to either receive standard of care treatment alone, or standard of care treatment with the additional intervention of posture training. The nature of the intervention prevents blinding. All patients will be followed for 6 weeks and evaluated for symptom improvement or resolution.

All patients aged 18 and older who present to clinic with cubital tunnel syndrome of any severity and who have not previously undergone surgical intervention for this condition will be eligible to participate in this study. All participants must be amenable to conservative management of CuTS, wearing a posture training device daily, completing the accompanying questionnaires throughout the study, and returning for follow-up.

03

Conditions studied

  • Cubital Tunnel Syndrome
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provision of signed and dated form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Adult patients, between 18 and 99 years old
  • Exhibiting signs and symptoms consistent with cubital tunnel syndrome including but not limited to pain, numbness, or paresthesia in an ulnar distribution, loss of grip strength, or loss of fine motor control of the fingers.
  • Nerve conduction study, electromyography, MRI or ultrasound results consistent with the diagnosis of cubital tunnel syndrome
  • Ability to wear a posture trainer daily and manage the associated smartphone application and questionnaire

Exclusion criteria

Exclusion Criteria:

  • History of spinal surgery, hand surgery or hand/wrist fracture
  • History of cubital tunnel release surgery or carpal tunnel syndrome
  • Pregnancy or lactation
  • Known allergic reactions to silicon
  • Long-standing history of T2DM, documented neuropathic pain
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    normal conservative management + posture training

    Participants will receive normal conservative management as well as posture training via the UpRight Go posture trainer. The device will be provided to participants with all supplies and instructions that come from the original manufacturer and will be walked through how to install and use the necessary smartphone application as well as wear the posture trainer. Participants will be asked to wear the device daily for six weeks with goals for the amount of time spent wearing the sensor each day provided by the smartphone app. Participants will return to clinic in six weeks to return the device and submit usage data, or will mail back the device. Devices will be cleaned with disinfectant wipes before use by future participants.

    Device: UpRight Go

  • No intervention
    normal conservative management only (standard of care)

    Participants will receive conservative management.only: standard of care for initial treatment of cubital tunnel syndrome

Interventions

  • DeviceUpRight Go

    The UpRight Go posture trainer is a commercially available biofeedback sensor that externally attaches to the wearer via a necklace or silicon adhesive. It vibrates when it senses that the wearer is slouching and connects to a smartphone application which sets daily goals, tracks usage, and provides assistance and support. It complies with International Electrotechnical Commission (IEC) standards.

06

What researchers measure

Primary outcomes

  1. Change in pain score for pain using a Visual Analogue Scale (VAS)

    Pain score assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.

    Time frame: Baseline and 6 weeks

  2. Change in pain score for numbness using a Visual Analogue Scale (VAS)

    Pain score for numbness assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.

    Time frame: Baseline and 6 weeks

  3. Change in pain score for weakness using a Visual Analogue Scale (VAS)

    Pain score for weakness assessed using a linear VAS: a straight horizontal line of fixed length (100mm) on which participants will mark the point on the line that they feel represents their perception of their current state. The VAS score is determined by measuring, in millimeters, from the left hand end of the line to the point that the patient marks. The scale ranges from "no pain" to "severe pain". The longer the distance on the line, the more pain.

    Time frame: Baseline and 6 weeks

Secondary outcomes

  1. Change in The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

    The DASH questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. Each item is scored on a 5 point Likert scale. Total score ranges from 0 (no disability) to 100 (most severe disability). Higher scores indicate a greater level of disability and severity.

    Time frame: Baseline and 6 weeks

  2. Change in strength testing via pinch/grip test

    Pinch testing involves the patient pinching a pinchmeter, which measures the strength of the patient's pinch. Grip testing involves the patient gripping a dynamometer. The force that the patient is able to exert on the pinchmeter/dynamometer is measured in lbs/kgs, Newtons, or Pascals, and a higher reading indicates a greater strength. This provides valuable information about how a patient's strength is affected by cubital tunnel syndrome.

    Time frame: Baseline and 6 weeks

  3. Change in Medical Research Council (MRC) Scale for Muscle Strength

    The MRC Scale is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). This score was defined as the sum of MRC scores from six muscles in the upper and lower limbs on both sides so that the score ranged from 60 (normal) to 0 (quadriplegic). The Criteria requires that each of the six muscle groups listed in the table are examined bilaterally.

    Time frame: Baseline and 6 weeks

  4. Change in range of motion testing

    Patients will be asked to actively move their upper body through a series of movements and postures, testing for flexibility in the neck, shoulders, elbows, and wrists. Limitations in movement are recorded qualitatively, which indicates the potential presence of concomitant pathology in the upper extremities, which could affect a patient's response to treatment.

    Time frame: Baseline and 6 weeks

  5. Change in two-point discrimination testing

    A caliper or two point discriminator is used to apply pressure to a patient's finger tips. The patient is then asked to determine if one or two points of pressure are present, with the distance between the two points changing. The lowest distance between two points that the patient can distinguish is recorded in millimeters. A smaller distance indicates better fine-touch sensation at the finger tips and can indicate the quality of sensory nerves at the distal upper extremity.

    Time frame: Baseline and 6 weeks

  6. Change in Semmes-Weinstein monofilament testing.

    The Semmes-Weinstein monofilament (SWM) testing is one of the clinical tests that measures the response to a touching sensation of the monofilaments using a numerical quantity. The monofilament is a small strand of nylon attached to a plastic base at fixed spacing's from 2mm to 15mm. The provider uses this monofilament to check for loss of feeling on your foot.

    Time frame: Baseline and 6 weeks

  7. Change in Boston Carpal Tunnel Syndrome (BCTS) questionnaire

    The BCTS is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. The Symptom Severity Scale (SSS) with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale (FSS) with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as difficult. A final score is calculated for each scale (the sum of the individual scores divided by the number of items) and ranges from 1 to 5, with a higher score indicating a more severe handicap.

    Time frame: Baseline and 6 weeks

  8. Hours per day device was worn

    The mean hours per day device was worn

    Time frame: up to 6 weeks

  9. Time spent with good posture

    The mean time spent with good posture while wearing the device

    Time frame: up to 6 weeks

07

Study locations

1 site
  • Yale New Haven Hospital
    New Haven, Connecticut 06520, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2023 to primary completion in Jul 2024, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2023
First posted
Oct 23, 2023
StartActual
Dec 15, 2023
Primary completionActual
Jul 24, 2024
CompletionActual
Jul 24, 2024
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06095011
Lead sponsor
Yale University
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Dec 15, 2023
Primary completion
Jul 24, 2024
Completion
Jul 24, 2024
Last update
Sep 23, 2026

Study contacts

Elspeth Hill, MBChB, PhD, MRes, MRCS
principal investigator · Yale University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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