Trial · NCT01621113
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in 6-Minute Walk Test (6MWT) Distance at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) Visits | The 6MWT measures the distance (in meters) walked within 6 minutes. The test is a measure of endurance; however, can also be used to measure walking speed. |
| Secondary | Change in 10-Meter Walk Test (10MWT) Speed at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The 10MWT measures the time in seconds that it takes a person to walk 10m. The test is a measure of functional capacity and assesses short-duration walking speed. |
| Secondary | Change in Timed 25-foot walk (T25FW) Speed at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The T25FW is a quantitative measure of lower extremity function in persons with multiple sclerosis. The T25FW was the primary outcome measure of efficacy used in MS studies of dalfampridine and is being performed in our study as a means of comparing results across studies and populations. The T25FW can be measured during the 10MWT. |
| Secondary | Change in Walking Index for Spinal Cord Injury II (WISCI II) Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The WISCI II is a walking scale specifically developed for use in clinical trials in persons with incomplete SCI. Walking ability is scored on a 21-point ordinal scale (0-20, where 0 indicates a person is unable to stand and/or participate in assisted walking and 20 indicates a person can walk more than 10m without walking aids or physical assistance), where a lower number indicates higher impairment. |
| Secondary | Change in Spinal Cord Injury Functional Ambulation Index (SCI-FAI) Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The SCI-FAI is an observational gait assessment instrument that addresses three key domains of walking function in individuals with SCI. The three SCI-FAI subscales are Gait, Assistive Device, and Walking Mobility. Parameters of the SCI-FAI are measured during the first 2 minutes of the 6MWT (see above). |
| Secondary | Changes on International Standards for Neurological Classification of Spinal Cord Injury at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | Neurological examination will be performed using the International Standards for Neurological Classification. Sensory scores and lower extremity motor scores are derived at the time of this exam. |
| Secondary | Change in Lower-Extremity Motor Scores (LEMS) at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The LEMS measures strength in five muscle groups bilaterally (hip flexors, knee flexors and extensors, and ankle dorsiflexors) with the modified British Medical Research Council scale and is performed during the International Standards examination. |
| Secondary | Change in Berg Balance Scale (BBS) Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The BBS is a 14-item instrument originally designed to assess the risk for falls in community. |
| Secondary | Change in Modified Ashworth Scale (MAS) Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | Spasticity assessments will be performed at each study visit using the modified Ashworth scale (MAS). Ashworth scores will be averaged across three muscle groups bilaterally: hip adductors, knee extensors, and knee flexors. The Ashworth Scale data will be collected on a 1-5 scale rather than the published 0-4 scale. |
| Secondary | Change in Bowel Management Questionnaire Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The bowel management questionnaire uses a 6-point scale and requires the subject to rate the frequency (0, "Not at all"; 5, "Almost always") of ten items regarding bowel management over the past month. |
| Secondary | Change in Bladder Management Questionnaire Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The bladder management questionnaire uses a 6-point scale and requires the subject to rate the frequency (0, "Not at all"; 5, "Always or almost always") of eight items regarding bladder management over the past month. |
| Secondary | Change in Female Sexual Function Index (FSFI) Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The FSFI is a multidimensional, self-report instrument used to assess female sexual function. Six domains are identified that include desire, subjective arousal, lubrication, orgasm, sexual satisfaction, and pain. |
| Secondary | Change in International Index of Erectile Function (IIEF) Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The IIEF is a 15-item questionnaire to assess male sexual function. Quality of male sexual function is assessed in 5 domains, with 6 items that assess erectile function, 2 items that address orgasmic function, 2 questions that assess sexual desire, 3 items that assess intercourse satisfaction, and 2 items that assess overall sexual satisfaction. |
| Secondary | Changes in Pulmonary Function Tests at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | Pulmonary function testing will be performed (V max Spectra 29N, Carefusion, Yorba Linda, CA) to measure spirometric parameters, static lung volumes, cough strength, and maximal mouth expiratory and inspiratory pressures. |
| Secondary | Changes in Autonomic Function at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | To assess changes in autonomic cardiovascular function, heart rate (3 lead ECG Ivy Biomedical Systems, Inc. Branford, CT) and blood pressure (Finometer Midi, Finapres Medical Systems, Amsterdam, Netherlands) will be continuously monitored at 5 minute intervals at rest and during locomotor training. |
| Secondary | Changes on the International Spinal Cord Injury Pain Basic Data Set (ISCIPDS:B) at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The ISCIPDS:B contains core questions about clinically relevant information concerning SCI-related pain that can be collected by health-care professionals with expertise in SCI in various clinical settings. Each person is asked to describe the three worst pain problems he/she is currently experiencing. |
| Secondary | Change in Spinal Cord Independence Measure III (SCIM III) Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The SCIM is a measure of functional ability developed specifically for individuals with SCI to evaluate their performance of activities of daily living (ADL). The SCIM III is composed of 19 items in 3 sub-scales: (a) self-care (6 items, sub-score 0-20); (b) respiration and sphincter management (4 items, sub-score 0-40); and (c) mobility (9 items, sub-score 0-40). The total score ranges from 0 to 100. |
| Secondary | Change in Spinal Cord Injury-Functional Index (SCI-FI) Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The Spinal Cord Injury Functional Index (SCI-FI) is a comprehensive, SCI-specific measure to assess functional activities related to quality of life for individuals with SCI. The SCI-FI covers five distinct functional domains: Ambulation, Basic Mobility, Fine Motor Function, Self-Care (including bowel and bladder), and Wheeled Mobility. |
| Secondary | Change in 12-Item Short Form Health Survey (SF-12) Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The SF-12 is a generic health-status measure developed by RAND to assess outcomes of medical care and has been used previously by the SCI Model Systems. |
| Secondary | Change in Satisfaction with Life Scale (SWLS) Scores at 10 Weeks | Baseline, Mid-Point (Week 5), Final (Week 10), and Follow-up (Week 22) | The SWLS is a 5-item measure of the single concept of global life satisfaction. The SWLS is currently used in the SCI Model Systems dataset and normative data for individuals with SCI is available. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01621113/registered