N/A
Completed N=38
Rehabilitating Corticospinal Control of Walking
Source: ClinicalTrials.gov NCT02132650 ↗Enrolled (actual)
38
Serious AEs
5.3%
Results posted
Jun 2020
Primary outcomePrimary: Change in Walk Speed From Pre-Intervention (0 Months) to Post-Intervention (3 Months) — 0.13; 0.14 meters per second
Summary
The VHA estimates that over 15,000 Veterans incur a stroke each year. As the population of older Veterans grows, stroke will become an increasingly important problem to the VHA. Recovery of walking function is the most common goal of stroke survivors. The proposed study will test whether training with accurate walking tasks to engage the damaged supraspinal motor pathways is more effective than training with steady state walking. The investigators expect that training accurate tasks will be more effective, thereby improving walking function of Veteran stroke survivors and reducing the burden of care placed on families and on the VHA. Furthermore, this rehabilitation approach can be accomplished at comparable cost to existing rehabilitation approaches, which is important given that the VHA invests $88 million per year toward outpatient care, including physical rehabilitation, in the first six months after stroke. This research also has implications for rehabilitation of other neurologically injured populations, including traumatic brain injury and incomplete spinal cord injury.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Walk Speed From Pre-Intervention (0 Months) to Post-Intervention (3 Months) |
0.13; 0.14 | — |
| PRIMARY Change in Walk Speed From Pre-Intervention (0 Months) to Follow-Up (6 Months) |
0.10; 0.07 | — |
Eligibility Criteria
Inclusion Criteria
- occurrence of a single unilateral stroke within the previous 6-18 months (verified by MRI or CT from medical record)
- living in the community and able to travel to training and assessment sites
- approval of participation by primary care physician
- age 18 - 80 years
- lower extremity paresis indicated by Fugl-Meyer Assessment Score 10)
- severe obesity (body mass index > 35)
- uncontrolled hypertension (systolic > 200 mmHg and/or diastolic > 110 mmHg)
- uncontrolled diabetes with recent diabetic coma or frequent hypoglycemia
- bone fracture or joint replacement in the previous six months
- diagnosis of a terminal illness
- current participation in physical therapy or cardiopulmonary rehabilitation
- significant visual impairment affecting capability to gauge movement accuracy
- previous enrollment in a clinical trial for recovery of walking function
- current enrollment in any clinical trial
- planning to relocate out of the greater Gainesville FL area during the study period
- unable to communicate sufficiently with study personnel
- clinical judgment regarding safety or noncompliance
Data sourced from ClinicalTrials.gov (NCT02132650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.