Trial · NCT01621113
Combination Therapy With Dalfampridine and Locomotor Training for Chronic, Motor Incomplete Spinal Cord Injury
NCT01621113, Phase 2, Completed, Kessler Foundation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Therapy With Dalfampridine and Locomotor Training for Chronic, Motor Incomplete Spinal Cord Injury. Trials, record NCT01621113. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01621113
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Therapy With Dalfampridine and Locomotor Training for Chronic, Motor Incomplete Spinal Cord Injury
- NCT number
- NCT01621113
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Kessler Foundation
- Conditions
- Spinal Cord Injury
- Interventions
- Dalfampridine, Placebo
- First posted
- 2012-06-18
- Last updated
- 2017-12-02
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 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.
Grants0
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.
None in this release.
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/NCT01621113
GET https://conductscience.org/api/trials/v1/NCT01621113/registered?page=2