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Mechanisms of Walking Recovery After Stroke

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University of Cincinnati

Status

Completed

Conditions

Stroke

Treatments

Behavioral: No intervention
Behavioral: High-intensity interval training

Study type

Interventional

Funder types

Other

Identifiers

NCT02858349
2016-1916

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

30 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

10 participants in 1 patient group

Arm 1
Experimental group
Description:
4-week control period with no intervention and 4-weeks of high-intensity interval training
Treatment:
Behavioral: High-intensity interval training
Behavioral: No intervention

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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