Feasibility and Practice Characteristics of FNS and Gait Robot

Stroke Clinical Trial

Official title:

Feasibility and Practice Characteristics of FNS and Gait Robot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508755
• Other study ID #: B4036-I
• Status: Completed
• Phase: N/A
• First received: July 27, 2007
• Last updated: April 8, 2014
• Start date: August 2005
• Est. completion date: August 2009

Study information

• Verified date: April 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Gait Robot
gait training with the use of a gait robot
• Functional Neuromuscular stimulation with intramuscular electrodes
gait training with use of functional electrical stimulation

Locations

Country	Name	City	State
United States	VA Medical Center, Cleveland	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Dohring ME, Daly JJ. Automatic synchronization of functional electrical stimulation and robotic assisted treadmill training. IEEE Trans Neural Syst Rehabil Eng. 2008 Jun;16(3):310-3. doi: 10.1109/TNSRE.2008.920081. — View Citation

McCabe JP, Dohring ME, Marsolais EB, Rogers J, Burdsall R, Roenigk K, Pundik S, Daly JJ. Feasibility of combining gait robot and multichannel functional electrical stimulation with intramuscular electrodes. J Rehabil Res Dev. 2008;45(7):997-1006. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES.	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.	visit 48, following treatment	No