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Forced Rate Exercise + Rehab for Stroke

N/A

Recruiting

Led By Susan Linder, PT, DPT, PhD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fugl-Meyer score <34 in the involved LE demonstrating residual hemiparesis

Fugl-Meyer motor score 19-55 in the involved UE

Must not have

Hypertrophic cardiomyopathy

Dyspnea at rest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, end of treatment at 12 weeks, end of treatment + 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effects of forced aerobic exercise on motor recovery in stroke survivors. Traditional rehabilitation methods are costly and often leave stroke survivors with disabilities. The trial will investigate how forced aerobic exercise can

Who is the study for?

This trial is for stroke survivors with residual disability who can participate in outpatient rehab. It's not suitable for those unable to perform forced aerobic exercise or have conditions that exclude them from traditional rehabilitation.

What is being tested?

The study compares the effectiveness of adding forced rate cycling (mechanically assisted exercise) to regular rehab versus standard rehab alone, focusing on motor recovery and cost-effectiveness.

What are the potential side effects?

Potential side effects may include muscle soreness, fatigue, and increased heart rate due to the physical nature of forced aerobic exercise. Specific risks will depend on individual health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have weakness on one side of my body.

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My arm movement is moderately impaired.

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I can walk 20 meters or more with little to no help.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with hypertrophic cardiomyopathy.

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I feel short of breath even when I'm resting.

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I have a serious nerve condition, but it's not a stroke.

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I have not been hospitalized for heart issues like a heart attack or surgery in the last 3 months.

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I have an irregular heartbeat.

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I have been diagnosed with severe narrowing of the aortic valve in my heart.

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My blood pressure is not controlled by medication.

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I have severe tightening of my muscles or joints.

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I have an untreated blood clot in my leg or lung.

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I have unstable chest pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of treatment at 12 weeks and end of treatment + 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to end of treatment at 12 weeks and end of treatment + 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of treatment at 12 weeks and end of treatment + 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gait Velocity

Incremental cost-effectiveness ratio

Plasma IGF-1

+4 more

Secondary study objectives

Action Research Arm Test

Bimanual Dexterity Task

Biomechanical Dexterity Task

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Forced Rate Exercise + RehabilitationActive Control1 Intervention

The forced rate exercise+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to \>75 revolutions per minute (RPM). Target heart rate zone will be set to 60-80% of heart rate (HR) reserve. The session will consist of a 5-min warm-up, 35-min main exercise set, and 5-min cool down. Following FE, abbreviated sessions of motor learning-based training will be administered by a neurologic OT and PT experienced in stroke rehabilitation, with 30 min focused on restoration of UE function (OT) and 15 min focused on LE motor function/ gait training (PT).

Group II: RehabilitationActive Control1 Intervention

The rehab group will receive consecutive, full-length sessions of motor learning-based training, administered by a neurologic OT and PT experienced in stroke rehabilitation, with 45 min focused on restoration of UE function (OT) and 45 min focused on LE motor function/ gait training (PT).

0 / 14Eligibility criteria met