N/A
N=6
Feasibility and Practice Characteristics of FNS and Gait Robot
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00508755 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. — 0; 6; 6; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gait Robot (Device); Functional Neuromuscular stimulation with intramuscular electrodes (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. |
0; 6; 6; 6; 6; 6 | — |
Summary
Conventional therapies do not restore normal gait for many stroke survivors. The long-term goal of this work is to restore volitional lower limb motor control and gait following stroke. In our prior work, we demonstrated that it was feasible to provide a clinically operated, combined treatment of body weight supported treadmill training alone (BWSTT) + functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM).
Specific Aims and Hypothesis The purpose or Specific Aim of the study is to test the feasibility and gait training potential of combining the Lokomat and FNS-IM for stroke survivors. Given the feasibility of our clinically operated combination of BWSTT + FNS-IM, we propose to test the feasibility of the combination of Lokomat + FNS-IM.
Hypothesis I. It is feasible to utilize a clinically operated combination of Lokomat + functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM).
Treatment Procedures. The subjects will be treated for three months, four sessions/week (for a total of 48 treatment visits). A given session will be 1 hrs, with the time divided into thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) hr Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the subject is capable of volitionally executing a given movement or gait component. Population. The subjects will be chronic stroke survivors (>6 months after the stroke).
Eligibility Criteria
Inclusion Criteria
- Greater than or equal to 6 months after stroke
- 21 years or older
- Ability to follow 2 step commands
- Inability to move leg normally
Exclusion Criteria
- Pacemaker
- Progressive medical condition (i.e. Parkinsons Disease)
Data sourced from ClinicalTrials.gov (NCT00508755). 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.