Treadmill Training With Functional Electric Stimulation After Stroke

Stroke Clinical Trial

Official title:

Treadmill Training With Functional Electric Stimulation in Patients With Chronic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812472
• Other study ID #: 960053
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: June 21, 2016
• Start date: August 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2016
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to investigate the effects of the treadmill training with functional electric stimulation on sensorimotor cortical reorganization and functional improvement in subjects with chronic stroke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 82 Years

Eligibility

Inclusion Criteria:

• diagnosis of unilateral hemiparesis secondary to cerebrovascular accident with post-onset duration of more than 6 months

• ability to walk independently for at least 6 meters with or without use of walking aids

• ability to follow simple verbal commands or instructions

Exclusion Criteria:

• unstable medical conditions

• history of other diseases known to interfere with participation in the study

• past history of a seizure

• history of skin allergy to electrode

• use of a cardiac pacemaker

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Treadmill training with functional electrical stimulation

• Treadmill training without functional electrical stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N1 latency of somatosensory evoked potential		Change from baseline at 4 weeks
Primary	N1P1 amplitude of somatosensory evoked potential		Change from baseline at 4 weeks
Primary	motor threshold of motor evoked potential		Change from baseline at 4 weeks
Primary	map size of motor evoked potential		Change from baseline at 4 weeks
Secondary	Fugl-Meyer Assessment		Change from baseline at 4 weeks
Secondary	Motricity Index		Change from baseline at 4 weeks
Secondary	Berg Balance Scale		Change from baseline at 4 weeks
Secondary	walking speed		Change from baseline at 4 weeks
Secondary	Modified-Emory Functional Ambulation Profile	Measures a patient's ability to walk through 5 commonly experienced types of terrain.	Change from baseline at 4 weeks