Trial · NCT07894991
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| 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. |
| Other | Change in medial gastrocnemius muscle echogenicity | 4 weeks | Echogenicity is a measure of a tissue's "brightness." In muscle, this reflects the concentration of connective tissue and thus is a marker of muscle health. We will apply quantitative ultrasound image collection and analysis techniques to quantify the average echogenicity of the treated medial gastrocnemius muscle in longitudinal view. |
| Other | Change in medial gastrocnemius muscle echogenicity | 8 weeks | Echogenicity is a measure of a tissue's "brightness." In muscle, this reflects the concentration of connective tissue and thus is a marker of muscle health. We will apply quantitative ultrasound image collection and analysis techniques to quantify the average echogenicity of the treated medial gastrocnemius muscle in longitudinal view. |
| Other | Change in medial gastrocnemius fat fraction | 4 weeks | Using quantitative MRI techniques, the percentage of fat within the medial gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its fat percentage in each slice. Fat percentages will be averaged across each slice. |
| Other | Change in medial gastrocnemius fat fraction | 8 weeks | Using quantitative MRI techniques, the percentage of fat within the medial gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its fat percentage in each slice. Fat percentages will be averaged across each slice. |
| Other | Change in lateral gastrocnemius fat fraction | 4 weeks | Using quantitative MRI techniques, the percentage of fat within the lateral gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its fat percentage in each slice. Fat percentages will be averaged across each slice. |
| Other | Change in lateral gastrocnemius fat fraction | 8 weeks | Using quantitative MRI techniques, the percentage of fat within the lateral gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its fat percentage in each slice. Fat percentages will be averaged across each slice. |
| Other | Change in medial gastrocnemius muscle volume | 4 weeks | Using quantitative MRI techniques, the percentage of fat within the medial gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its cross sectional area. Cross sectional areas of each slice will be summed for total volume. |
| Other | Change in medial gastrocnemius muscle volume | 8 weeks | Using quantitative MRI techniques, the percentage of fat within the medial gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its cross sectional area. Cross sectional areas of each slice will be summed for total volume. |
| Other | Change in lateral gastrocnemius muscle volume | 4 weeks | Using quantitative MRI techniques, the percentage of fat within the lateral gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its cross sectional area. Cross sectional areas of each slice will be summed for total volume. |
| Other | Change in lateral gastrocnemius muscle volume | 8 weeks | Using quantitative MRI techniques, the percentage of fat within the lateral gastrocnemius will be calculated. MRI images of the calf will be collected. A custom image analysis program will allow for manual segmentation of the muscle and calculation of its cross sectional area. Cross sectional areas of each slice will be summed for total volume. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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