Feasibility and Practice Characteristics of FNS and Gait Robot

NCT00508755 | Completed Results

• 1 other identifier: B4036-I
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

cerebrovascular accident; electrical stimulation; gait training; motor learning

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Arm 1

EXPERIMENTAL

stroke

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

Interventions

Gait Robot DEVICE

gait training with the use of a gait robot

Arm 1

Functional Neuromuscular stimulation with intramuscular electrodes DEVICE

gait training with use of functional electrical stimulation

Arm 1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than or equal to 6 months after stroke
• years or older
• Ability to follow 2 step commands
• Inability to move leg normally

You may not qualify if:

• Pacemaker
• Progressive medical condition (i.e. Parkinsons Disease)

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• 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.

  PMID: 19165689 RESULT

• 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.

  PMID: 18586610 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

This was a feasibility study to determine the possibility of combining two technologies. Further study of the combined treatment is needed to determine whether the feasible combined treatment is more effective than other methods.

Results Point of Contact

• Title: Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center of Excellence
• Organization: Malcom Randall VA Medical Center, Gainesville Florida

janis.daly@neurology.ufl.edu

(352) 376-1611

Study Officials

• Janis Daly, PhD MS

  VA Medical Center-Cleveland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2007
• First Posted: July 30, 2007
• Study Start: August 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 25, 2014
• Results First Posted: April 2, 2014

Record last verified: 2014-04

Locations

US (1)