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N/A N=20 Randomized Single-blind Treatment

Heart-Brain Retraining for Stroke Rehabilitation

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT02076776 ↗
Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Aug 2018
Primary outcome: Primary: Wolf Motor Function Test (WMFT) — 45.17; 49.75; 59.83; 49.80 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Repetitive Task Practice (RTP) (Behavioral); Voluntary cycling + RTP (Behavioral); Assisted cycling + RTP (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The Cleveland Clinic
Primary completion
Nov 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Wolf Motor Function Test (WMFT)		 45.17; 49.75; 59.83; 49.80; 48.83; 68.67 —
SECONDARY
The Fugl-Meyer Assessment (FMA)		 26.83; 34.75; 36.17; 29.80; 35.33; 48.50 —

Summary

The purpose of this study is to gain a better understanding of how different types of exercise can help people after a stroke. The investigators want to study if different types of exercise will improve the use of arm and hand function after a stroke.

Eligibility Criteria

Inclusion Criteria

  • Able to provide informed consent
  • Within 6-12 months of diagnosis of single ischemic or hemorrhagic stroke, confirmed with neuroimaging
  • Fugl-Meyer Motor Score 19-55 in involved upper extremity
  • Approval from patient's primary care physician
  • Age between 18 and 85 years

Exclusion Criteria

  • Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment
  • Serious cardiac arrhythmia
  • Hypertrophic cardiomyopathy
  • Severe aortic stenosis
  • Cardiac pacemaker
  • Pulmonary embolus
  • Other medical or musculoskeletal contraindication to exercise
  • Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation
  • Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment
  • Pregnancy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02076776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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