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NCT05432999 · ClinicalTrials.gov registry record · NA
Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury
A NA study of Spinal Cord Injuries and Tetraplegia, sponsored by Kessler Foundation.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05432999 is a NA study of Spinal Cord Injuries and Tetraplegia that is actively recruiting participants, run by Kessler Foundation. The registered enrollment target is 30 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05432999, a NA study of Spinal Cord Injuries and Tetraplegia, is actively recruiting participants, sponsored by Kessler Foundation.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
People with spinal cord injury (SCI) experience a host of secondary complications that can impact their quality of life and functional independence. One of the more prevalent complications is spasticity, which occurs in response to spinal cord damage and the resulting disruption of motor pathways. Common symptoms include spasms and stiffness, and can occur more than once per hour in many people with SCI. Spasticity can have a negative impact over many quality of life domains, including loss of functional independence, activity limitations, and even employment. Its impact on health domains is also pronounced, with many people who have spasticity reporting mood disorders, depression, pain, sleep disturbances, and contractures. Spasticity can interfere with post-injury rehabilitation and lead to hospitalization. There are many treatments for spasticity in this population. However, many do not have long-term efficacy, and, if they do, they are often pharmacological in nature and carry side effects that could limit function or affect health. The goal of this pilot, randomized-controlled study is to investigate the potential efficacy and safety of a non-invasive treatment with a low side effect profile, extracorporeal shockwave therapy (ESWT). ESWT has shown some benefits in people with post-stroke spasticity with no long term side effects. Thirty individuals with chronic, traumatic SCI will be recruited. Fifteen will be provided with ESWT while the other fifteen will be given a sham treatment. Clinical and self-report measures of spasticity and its impact on quality of life will be collected, as well as quantitative ultrasound measures of muscle architecture and stiffness. The ultimate goal of this pilot project is to collect the data necessary to apply for a larger randomized-controlled trial. Conducting a larger trial will allow for a more powerful estimation of safety and efficacy of ESWT as a treatment for spasticity in people with SCI.
Conditions Studied
Interventions
- DEVICE Extracorporeal Shockwave Therapy
Study Locations (1)
New Jersey
- Kessler Foundation - West Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2026-02-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05432999
The ClinicalTrials.gov registry entry for NCT05432999 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (51% lower). The listed sponsor is Kessler Foundation, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Spinal Cord Injuries appearing as the primary indexed condition, and to 1 intervention - of which Extracorporeal Shockwave Therapy is the first listed.
NCT05432999 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT05432999 about?
NCT05432999 is a clinical study titled "Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury". People with spinal cord injury (SCI) experience a host of secondary complications that can impact their quality of life and functional independence. One of the more prevalent complications is spasticity, which occurs in response to spinal cord damage and the resulting disruption of motor pathways. C...
What is the current status of trial NCT05432999?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2022-09-01. Estimated completion is 2026-02-01.
What conditions does trial NCT05432999 study?
This clinical trial studies the following conditions: Spinal Cord Injuries, Tetraplegia, Spasticity, Muscle, Paraplegia, Spastic Paraplegia.
What interventions are being tested in trial NCT05432999?
The interventions under investigation include: Extracorporeal Shockwave Therapy (DEVICE).
Who is sponsoring clinical trial NCT05432999?
This trial is sponsored by Kessler Foundation, which has 104 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05432999 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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