Trial · NCT07894991
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
NCT07894991, Phase 2, Recruiting, Kessler Foundation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury. Trials, record NCT07894991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07894991
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
- NCT number
- NCT07894991
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Kessler Foundation
- Conditions
- Spinal Cord Injury, Spasticity
- Interventions
- Focused extracorporeal shockwave therapy, Botulinum toxin, Sham
- First posted
- 2026-10-26
- Last updated
- 2026-11-04
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Modified Ashworth Scale score | 8 weeks | The Modified Ashworth Scale (MAS) is a physical exam maneuver used frequently both clinically and for research purposes to assess the increase in velocity-dependent muscle tone after neurologic disorders. We will be focusing on the MAS score of the ankle plantar flexors. This measure is included in the NINDS list of CDE recommendations for SCI. Specifically, it evaluates the resistance to passive stretch of the ankle joint through full range of motion. Scores range from 0 (no spasticity) to 4 (severe spasticity). |
| Secondary | Change in Modified Ashworth Scale score | 4 weeks | The Modified Ashworth Scale (MAS) is a physical exam maneuver used frequently both clinically and for research purposes to assess the increase in velocity-dependent muscle tone after neurologic disorders. We will be focusing on the MAS score of the ankle plantar flexors. This measure is included in the NINDS list of CDE recommendations for SCI. Specifically, it evaluates the resistance to passive stretch of the ankle joint through full range of motion. Scores range from 0 (no spasticity) to 4 (severe spasticity). |
| Secondary | Change in Modified Penn Spasticity Frequency Scale | 4 weeks | The Modified Penn Spasticity Frequency Scale (mPSFS) is a self-report scale with two components, which is meant to provide a more complete understanding of an individual's spasticity status. The first component is comprised of a five-point scale, which assesses spasm frequency between 0 ("no spasms") and 4 ("spontaneous spasms occurring more than 10 times per hour"). The second component includes a three-point scale, which assesses spasm severity between 1 ("mild") and 3 ("severe"); this component is not answered if the individual reports no spasms in part one. |
| Secondary | Change in Modified Penn Spasticity Frequency Scale | 8 weeks | The Modified Penn Spasticity Frequency Scale (mPSFS) is a self-report scale with two components, which is meant to provide a more complete understanding of an individual's spasticity status. The first component is comprised of a five-point scale, which assesses spasm frequency between 0 ("no spasms") and 4 ("spontaneous spasms occurring more than 10 times per hour"). The second component includes a three-point scale, which assesses spasm severity between 1 ("mild") and 3 ("severe"); this component is not answered if the individual reports no spasms in part one. |
| Secondary | Change in Modified Patient-Reported Impact of Spasticity Measure | 4 weeks | The Modified Patient-Reported Impact of Spasticity Measure (mPRISM) is a self-reported instrument with 37 items to quantify the impact of spasticity on physical, psychological, and social health-related QOL domains. Each item is rated using a scale of 0 ("never") to 3 ("often/very often"). The scale's psychometric properties have been well-established, including floor and ceiling effects for the various subscales, and it has been shown to be both valid and reliable. |
| Secondary | Change in Modified Patient-Reported Impact of Spasticity Measure | 8 weeks | The Modified Patient-Reported Impact of Spasticity Measure (mPRISM) is a self-reported instrument with 37 items to quantify the impact of spasticity on physical, psychological, and social health-related QOL domains. Each item is rated using a scale of 0 ("never") to 3 ("often/very often"). The scale's psychometric properties have been well-established, including floor and ceiling effects for the various subscales, and it has been shown to be both valid and reliable. |
| Secondary | Participant Global Impression of Change | 4 weeks | The Participant Global Impression of Change (PGIC) measures global treatment effect by asking the participant to rate with a 7-point scale (anchored by 1 \["very much worse"\] and 7 \["very much improved"\]) their overall impression following treatment as compared to prior. This scale provides an indication of clinically important improvement and has been used to assess efficacy of spasticity treatments in SCI. 11-week scores will be considered a primary outcome. |
| Secondary | Participant Global Impression of Change | 8 weeks | The Participant Global Impression of Change (PGIC) measures global treatment effect by asking the participant to rate with a 7-point scale (anchored by 1 \["very much worse"\] and 7 \["very much improved"\]) their overall impression following treatment as compared to prior. This scale provides an indication of clinically important improvement and has been used to assess efficacy of spasticity treatments in SCI. 11-week scores will be considered a primary outcome. |
| Secondary | Change in ankle range of motion | 4 weeks | Passive plantar flexion and dorsiflexion ROM will be measured using a goniometer during the MAS assessment by the same blinded clinician. The participant will assume a supine position. Use of a universal goniometer is generally considered a reliable method of measuring passive ankle ROM in a clinical setting among patients with neurological conditions. |
| Secondary | Change in ankle range of motion | 8 weeks | Passive plantar flexion and dorsiflexion ROM will be measured using a goniometer during the MAS assessment by the same blinded clinician. The participant will assume a supine position. Use of a universal goniometer is generally considered a reliable method of measuring passive ankle ROM in a clinical setting among patients with neurological conditions. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21HD123083 | Randomized, sham-controlled trial to investigate extracorporeal shockwave therapy as an adjunctive treatment for spasticity secondary to spinal cord injury | Hogaboom, Nathan | KESSLER FOUNDATION, INC. | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT | 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07894991
GET https://conductscience.org/api/trials/v1/NCT07894991/registered