Feasibility and Practice Characteristics of FNS and Gait Robot

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Stroke

Treatments: Device: Gait Robot; Device: Functional Neuromuscular stimulation with intramuscular electrodes

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00508755

B4036-I

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Arm 1

Experimental group

Description:

stroke

Treatment:

Device: Functional Neuromuscular stimulation with intramuscular electrodes

Device: Gait Robot