Innovative Modalities for Restoring Upper Limb Function Post Stroke

Cerebrovascular Accident Clinical Trial

Official title:

Innovative Modalities for Restoring Upper Limb Function Post Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725659
• Other study ID #: B2801R
• Status: Completed
• Phase: N/A
• First received: November 9, 2012
• Last updated: November 9, 2012
• Start date: September 2001
• Est. completion date: December 2009

Study information

• Verified date: November 2012
• Source: Malcom Randall VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

PURPOSE. After stroke many patients are unable to engage in normal upper limb functional activities, which may restrict them from participation in meaningful life roles. For many, conventional rehabilitation does not restore upper limb function to a useful level. The purpose of this research is to investigate the benefits of three promising motor learning interventions: focused intensive, motor learning (FIML); 2) robotics and motor learning (ROB-ML); and 3) functional neuromuscular stimulation and motor learning (FNS-ML).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >1 year post stroke no acute, uncontrolled medical condition single stroke

Exclusion Criteria:

• pacemaker other neurological condition more than one stroke

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Other:
• Motor Learning
training of the hemiplegic upper limb with motor learning
• Robotics
subjects perform training of hemiplegic arm using an upper extremity robot
• surface FES
subjects are provided with surface FES to the hemiplegic upper limb

Locations

Country	Name	City	State
United States	Louis Stokes Cleveland Department of Veterans Affairs Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Malcom Randall VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer	impairment measure of coordination of the upper limb	after 12 weeks of intervention	No