Combined Tibial Nerve Stimulation and Standing for People With SCI

April 2, 2026 updated by: Tania Lam, University of British Columbia

Changes in Pelvic Floor Function With Tibial Neuromodulation Combined With Standing Therapy

The goal of this clinical trial is to understand how sensory inputs from the lower leg can influence pelvic floor muscle function and urogential function in adults with chronic spinal cord injury (SCI). The main questions it aims to answer are:

  1. What is the modulatory role of load and posture on reflex activation of the pelvic floor muscles in participants with SCI?
  2. What is the feasibility of combining tibial neuromodulation with standing therapy in participants with SCI?
  3. What are the potential effects of combined tibial neuromodulation and standing therapy on reflex excitability and urogential symptoms and quality of life in people with SCI?

Participants will be asked complete a series of assessments (questionnaires, electrophysiological testing) before and after a 12-week intervention of combined standing and tibial nerve stimulation therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

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 Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M0
        • Recruiting
        • ICORD
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 19 years of age
  • Have a SCI between C7 - T10 that occurred at least 12 months previously
  • Have a motor-complete or incomplete SCI (AIS A, B, C, or D)
  • Have symptoms of neurogenic LUT dysfunction
  • Meet the manufacture requirements for standing frame use (will be evaluated by the research team)
  • Are able to speak and understand English.

Exclusion Criteria:

  • Have changed their bladder management program in the past month
  • Have received an injection of Botulinum toxin-A in any LUT structure in the past 2 weeks, or intend to receive an injection while participating in the trial
  • Have a non-stable SCI (e.g. spinal tumor)
  • Have signs of a lower motoneuron injury (e.g. cauda equina syndrome)
  • Have other neurological injury besides SCI
  • Have an implanted metallic or electronic device (e.g. pace maker, nerve stimulator)
  • Have a condition for which exercise or transcutaneous stimulation is contraindicated
  • Have a severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, pressure sores, musculoskeletal injury, or unmanage blood pressure.
  • Are currently pregnant or have given birth within the past 12 months
  • Use walking as your primary means of movement around your home and the community.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standing + Tibial Nerve Stimulation
Behavioral: Standing + Tibial Nerve Stimulation
Standing (with the support of a standing frame) combined with transcutaneous tibial nerve stimulation 3x/week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Floor Muscle Reflex Excitability
Time Frame: At baseline to within 2 weeks of completing the study intervention
We will electrically stimulate the tibial nerve and record reflexes responses from the pelvic floor muscles using perianal surface electromyography. We will examine the amplitude of the reflex response.
At baseline to within 2 weeks of completing the study intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - Recruitment Rate
Time Frame: Through study completion, an average of 8 months
Recruitment rate will be evaluated by number of participants approached, screened for eligibility, as well as reasons for exclusions.
Through study completion, an average of 8 months
Feasibility - Adherence
Time Frame: Through study completion, an average of 8 months
Adherence will be tracked by the compliance of participants to the intervention, with reasons for missed sessions or drop-outs noted.
Through study completion, an average of 8 months
Feasibility - Adverse Events
Time Frame: Through study completion, an average of 8 months
Any adverse events to study protocols will be recorded.
Through study completion, an average of 8 months
Acceptability
Time Frame: Through study completion, an average of 3 months
The acceptability of the intervention will be evaluated using a 7-point Likert scale to rate participants' opinions about the intervention (enjoyment and perceived benefits) and the outcome measures (tolerability and appropriateness of the measurement procedures). A higher score indicates a more acceptable intervention.
Through study completion, an average of 3 months
Neurogenic Bladder Symptoms Score (NBSS)
Time Frame: Through study completion, an average of 8 months
Participants will be asked to respond to 24 questions regarding the severity of their bladder symptoms secondary to neurological injury. Questions cover three subdomains: incontinence, storage and voiding, and consequences. The total score on this questionnaire ranges from 0-74, where a lower score represents less severe symptoms.
Through study completion, an average of 8 months
Incontinence Quality of Life Questionnaire (I-QoL)
Time Frame: Through study completion, an average of 8 months
Participants will be asked to respond to 22 questions about how urinary incontinence impacts their quality of life using a 5-point scale with values ranging from 1 (extremely) to 5 (not at all). The questionnaire probes three subdomains of how incontinence may affect quality of life: avoidance and limiting behavior, psychosocial impact, and social embarrassment. Total score on this questionnaire ranges from 0-100, where a higher score represents higher quality of life.
Through study completion, an average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

The Craig H. Neilsen Foundation

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 (Estimated)

April 2, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H25-01193

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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