Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation
Cost-effectiveness and Efficacy of a Combined Intervention to Facilitate Motor Recovery Following Stroke
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to investigate whether aerobic exercise improves the participant's ability to recover function in the arm and leg affected by the participant's stroke. The investigators are also calculating the cost effectiveness of the rehabilitation interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Apr 2019
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2019
CompletedFirst Posted
Study publicly available on registry
January 29, 2019
CompletedStudy Start
First participant enrolled
April 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedResults Posted
Study results publicly available
July 29, 2025
CompletedJuly 29, 2025
July 1, 2025
4.8 years
January 17, 2019
May 2, 2025
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Baseline
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
midpoint (4 weeks from Baseline)
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
end of treatment (8 weeks from Baseline)
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
end of treatment +4 weeks (12 weeks from Baseline)
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
end of treatment +6 months (8 months from Baseline)
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
end of treatment +1 year (14 months from Baseline)
Action Research Arm Test (ARAT)
The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
Baseline
Action Research Arm Test (ARAT)
The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
end of treatment (8 weeks from Baseline)
Action Research Arm Test (ARAT)
The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
end of treatment +4 weeks (12 weeks from Baseline)
Action Research Arm Test (ARAT)
The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
end of treatment +6 months (8 months from Baseline)
Action Research Arm Test (ARAT)
The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
end of treatment +1 year (14 months from Baseline)
Secondary Outcomes (53)
Wolf Motor Function Test (WMFT)
Baseline
Stroke Impact Scale (SIS)
Baseline
Stroke Impact Scale (SIS)
end of treatment (8 weeks from Baseline)
Stroke Impact Scale (SIS)
end of treatment +6 months (8 months from Baseline)
Stroke Impact Scale (SIS)
end of treatment +1 year (14 months from Baseline)
- +48 more secondary outcomes
Study Arms (2)
Aerobic Exercise & Repetitive Task Practice
ACTIVE COMPARATORParticipants will perform the following: 1. 45 minutes of cycling 2. 45 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice Only
ACTIVE COMPARATORParticipants will perform the following: 1\. 90 minutes of upper extremity repetitive arm exercises
Interventions
Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
Repetitive arm exercises
Eligibility Criteria
You may qualify if:
- ≥ 6 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging,
- Fugl-Meyer motor score 19-55 in the involved upper extremity,
- Ambulatory ≥ 20 meters with no more than contact guard assistance, and
- years of age.
You may not qualify if:
- hospitalization for myocardial infarction, heart failure or heart surgery within 3 months,
- cardiac arrhythmia,
- hypertrophic cardiomyopathy,
- severe aortic stenosis,
- pulmonary embolus,
- significant contractures,
- anti-spasticity injection within 3 months of enrollment and
- other contraindication to exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
Related Publications (3)
Linder SM, Rilinger R, Learman K, Miller Koop M, Streicher M, Davidson S, Miller C, Harris D, Corrigan P, Bethoux F, Alberts JL. Forced-Rate Aerobic Cycling Improves Locomotor Function and Gait Biomechanics in Individuals With Chronic Stroke: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Dec 1;104(12):1147-1154. doi: 10.1097/PHM.0000000000002785. Epub 2025 Jul 4.
PMID: 40720308DERIVEDLinder SM, Bischof-Bockbrader A, Davidson S, Li Y, Lapin B, Singh T, Lee J, Bethoux F, Alberts JL. The Utilization of Forced-Rate Cycling to Facilitate Motor Recovery Following Stroke: A Randomized Clinical Trial. Neurorehabil Neural Repair. 2024 Apr;38(4):291-302. doi: 10.1177/15459683241233577. Epub 2024 Feb 29.
PMID: 38420848DERIVEDLinder SM, Lee J, Bethoux F, Persson D, Bischof-Bockbrader A, Davidson S, Li Y, Lapin B, Roberts J, Troha A, Maag L, Singh T, Alberts JL. An 8-week Forced-rate Aerobic Cycling Program Improves Cardiorespiratory Fitness in Persons With Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 May;105(5):835-842. doi: 10.1016/j.apmr.2024.01.018. Epub 2024 Feb 11.
PMID: 38350494DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Susan Linder, PT, DPT, PhD
- Organization
- The Cleveland Clinic Foundation
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Linder, DPT
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Project Scientist, Principle Investigator
Study Record Dates
First Submitted
January 17, 2019
First Posted
January 29, 2019
Study Start
April 11, 2019
Primary Completion
January 31, 2024
Study Completion
January 31, 2024
Last Updated
July 29, 2025
Results First Posted
July 29, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share