Feasibility and Practice Characteristics of FNS and Gait Robot

NCT ID: NCT00508755

Last Updated: 2014-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2009-08-31

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).

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

stroke

Group Type: EXPERIMENTAL

Gait Robot

Intervention Type: DEVICE

gait training with the use of a gait robot

Functional Neuromuscular stimulation with intramuscular electrodes

Intervention Type: DEVICE

gait training with use of functional electrical stimulation

Interventions

Gait Robot

gait training with the use of a gait robot

Intervention Type: DEVICE

Functional Neuromuscular stimulation with intramuscular electrodes

gait training with use of functional electrical stimulation

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janis Daly, PhD MS

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center-Cleveland

Locations

VA Medical Center, Cleveland

Cleveland, Ohio, United States

Countries

United States

References

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. doi: 10.1682/jrrd.2007.08.0124.

Reference Type: RESULT

PMID: 19165689 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18586610 (View on PubMed)

Other Identifiers

B4036-I

Identifier Type: -

Identifier Source: org_study_id