Mechanisms of Walking Recovery After Stroke

Stroke Clinical Trial

Official title:

Mechanisms of Walking Recovery After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02858349
• Other study ID #: 2016-1916
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention.

Description:

Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention using high-intensity interval training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• age 30-90 years

• unilateral stroke experienced >6 months prior to enrollment in middle cerebral artery (MCA) territory without complete disruption of the putamen on the lesion side

• walking speed <= 1.0 m/s on the 10 meter walk test

• able to walk 10m over ground with assistive devices as needed and no physical assistance

Exclusion Criteria:

• MRI incompatibility (e.g. metallic or electronic implants, severe claustrophobia)

• inability to perform mental imagery (time dependent motor imagery screening test [TDMI])

• evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test, or significant baseline ECG abnormalities that would make an exercise ECG uninterpretable

• recent (<3 months) cardiopulmonary hospitalization

• unable to communicate with investigators or correctly answer consent comprehension questions

• significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)

• severe lower extremity (LE) spasticity (Ashworth >2)

• recent (<3 months) illicit drug or alcohol abuse or significant mental illness

• major post-stroke depression (PHQ-9 =10) in the absence of medical management

• participating in physical therapy or another interventional research study;

• recent (<3 months) paretic LE botulinum toxin injection

• concurrent progressive neurologic disorder or other major medical, orthopedic or peripheral vascular conditions that would limit improvement

• pregnancy

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• No intervention
No intervention
• High-intensity interval training
High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking Speed	10-meter walk test	Change from 4-weeks to 8-weeks
Secondary	Gait Symmetry	Paretic step ratio	baseline, 4 weeks, 8 weeks
Secondary	Metabolic Cost of Gait	oxygen consumption rate during comfortable speed gait	baseline, 4 weeks, 8 weeks
Secondary	Aerobic Capacity	oxygen consumption rate during exercise testing	baseline, 4 weeks, 8 weeks
Secondary	NIH Toolbox - Cognition Domain		baseline, 4 weeks, 8 weeks
Secondary	NIH Toolbox Standing Balance Test		baseline, 4 weeks, 8 weeks
Secondary	Stroke and Aphasia Quality of Life Scale		baseline, 4 weeks, 8 weeks
Secondary	Brain Locomotor Network Activation		baseline, 4 weeks, 8 weeks
Secondary	Brain Locomotor Network Connectivity		baseline, 4 weeks, 8 weeks
Secondary	Walking Capacity	6-minute walk test	baseline, 4 weeks, 8 weeks
Secondary	Daily Walking Activity	activity monitor	baseline, 4 weeks, 8 weeks
Secondary	Walking Speed	10-meter walk test	baseline, 4 weeks, 8 weeks