Feasibility and Practice Characteristics of FNS and Gait Robot

Not Applicable

Completed

Conditions: Stroke

Interventions: Device: Gait Robot
Device: Functional Neuromuscular stimulation with intramuscular electrodes

Registration Number: NCT00508755

Lead Sponsor: US Department of Veterans Affairs

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 6

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Gait Robot	stroke
Arm 1	Functional Neuromuscular stimulation with intramuscular electrodes	stroke

Primary Outcome Measures

Name	Time	Method
Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES.	visit 48, following treatment	Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES.

Secondary Outcome Measures