Stroke Rehabilitation Through Intensive Exercise

NCT07650500 | Not Yet Recruiting

• 1 other identifier: S-THRIVE
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn whether combining moderate to high intensity aerobic exercise with constraint-induced movement therapy (CI therapy) can improve walking ability in adults who have had a stroke. The study will also learn if telerehabilitation at home can support long-term recovery after intensive rehabilitation. The main questions this study aims to answer are:

• Does moderate to high intensity aerobic exercise before CI therapy improve walking ability, balance and lower extremity function in people with long-lasting gait difficulties after stroke?
• Does CI therapy alone lead to similar or different improvements in walking ability, balance or lower extremity function?
• Does telerehabilitation help participants maintain or further improve their function after the intensive rehabilitation period? Researchers will compare two groups. One group will receive 4 weeks of CI therapy, 5 days per week, plus 20 minutes of moderate-to-high-intensity aerobic exercise before the rehabilitation session on 3 of these days, and the other group will receive 4 weeks of CI therapy, 5 days per week, without preparatory aerobic exercise. After the completion of CI therapy, all participants will be offered an individualized 8-week telerehabilitation program to follow at home. They will use a mobile application to report physical activity and follow instructions for telerehabilitation. All participants will complete two assessment visits (about 3 hours each), 1-2 weeks before and 1-2 weeks after CI therapy. They will also complete questionnaires electronically after the telerehabilitation program. Daily activity will be measured twice during the study: once during a week after the intensive rehabilitation and once during a week after the telerehabilitation program. A small movement sensor worn on the thigh will be used. The sensor is attached with a soft strap or an adhesive patch and is comfortable to wear all day. The sensor shows how much a person walks, stands, or sits in everyday life. It is light, does not disturb normal activities, and only collects movement information for the study. An instruction sheet will be included to make it easy to use.

Conditions

Stroke; Rehabilitation; Rehabilitation Outcome; Aerobic Exercise; Telerehabilitation; Gait Impairment in Stroke Patients

Keywords

Aerobic exercise, stroke rehabilitation, constraint-induced movement therapy; telerehabilitation; gait impairment

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer Assessment for the lower extremity (LE-FMA)

  Fugl-Meyer Assessment (FMA) motor recovery.

  From enrollment to the end of the 4 week rehabilitation program

• Stroke Impact Scale (SIS)

  SIS reflects the patient's perceived functional improvement and quality of life.

  From start ( after the 4-week rehabilitation program) to the end of the 8 week telerehabilitation program.

• Daily physical activity levels

  Daily physical activity levels measured using a thigh worn accelerometry monitor. The physical activity monitors provide quantitative data on daily activity levels in natural environments.

  From start ( after the 4-week rehabilitation program) to the end of the 8 week telerehabilitation program.

Secondary Outcomes (4)

• Stroke Impact Scale (SIS)

  From enrollment to the end of the 4 week rehabilitation program

• Mini BESTest

  From enrollment to the end of the 4 week rehabilitation program

• Six minutes walk test

  From enrollment to the end of the 4 week rehabilitation program

• 10-Meter Walk Test (10 mWT)

  From enrollment to the end of the 4 week rehabilitation program

Other Outcomes (6)

• Montreal Cognitive Assessment

  From enrollment to the end of the 4 week rehabilitation program

• Hospital Anxiety and Depression scale

  At enrollment, at the end of 4 week rehabilitation program, and after the 8 week telerehabilitation period.

• Exercise Self Efficacy Scale

  At enrollment, at the end of rehabilitation program at 4 weeks, and after the 8week telerehabilitation period.

Study Arms (2)

LE-mCIMT- EXE

EXPERIMENTAL

Behavioral: LE-mCIMT-EXE

LE-mCIMT- TAU

ACTIVE COMPARATOR

Behavioral: LE- mCIMT-TAU

Interventions

LE-mCIMT-EXE BEHAVIORAL

LE-mCIMT-EXE (Lower Extremity Modified Constraint-Induced Movement Therapy + Moderate-to-High Intensity Aerobic Exercise) This intervention consists of a structured 4-week program of lower-extremity modified constraint-induced movement therapy (LE-mCIMT), delivered 5 days per week in an intensive rehabilitation setting. The program focuses on task-specific, repetitive, and progressively challenging lower-limb activities designed to improve gait function, balance, and mobility. What distinguishes this intervention from standard LE-mCIMT is the addition of a 20-minute bout of moderate-to-high intensity aerobic exercise performed immediately before therapy on three days each week. Aerobic exercise will be conducted on a recumbent stepper or ergometer cycle, with continuous heart-rate monitoring and ratings of perceived exertion. Following the 4-week intervention, all participants will receive 8 weeks of individualized telerehabilitation.

LE-mCIMT- EXE

LE- mCIMT-TAU BEHAVIORAL

LE-mCIMT-TAU (Lower Extremity Modified Constraint-Induced Movement Therapy) This intervention consists of a 4-week program of lower-extremity modified constraint-induced movement therapy (LE-mCIMT), delivered 5 days per week under the same therapeutic schedule and conditions as the experimental arm. Participants engage in intensive, task-specific training targeting lower-limb motor control, balance, and gait function. The therapeutic content, duration, therapist supervision, and overall structure mirror the experimental group to ensure comparability. The key distinction is that this arm does not include the 20-minute session of moderate-to-high intensity aerobic exercise prior to therapy. By withholding the exercise-priming component, this arm serves as an active comparator, allowing the study to isolate the addition effects of aerobic exercise on rehabilitation outcomes. Participants will receive 8 weeks of individualized telerehabilitation following completion of the 4-week LE-mCIMT.

LE-mCIMT- TAU

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years.
• History of a first-ever stroke occurring at least 6 months before enrollment.
• Independence in personal activities of daily living (e.g., dressing, undressing, and using the toilet).
• Ability to take a few steps indoors without a walking aid and without supervision; use of an orthosis is permitted.

You may not qualify if:

• Unstable cardiovascular disease or exercise-induced epilepsy.
• Insufficient cognitive ability to participate in group-based training, including the capacity to understand, follow, and maintain verbal instructions during exercise tasks.
• Blood pressure \>140/90 mmHg at the first visit.

Sponsors & Collaborators

• The Swedish School of Sport and Health Sciences: lead
• Neurology clinic, Stockholm: collaborator
• Neurocampus, Stockholm: collaborator
• Furuhöjden rehabcenter: collaborator
• Camp pro Ortopedteknik: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Maria Ekblom, professor

CONTACT

0700039586; maria.ekblom@gih.se

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: Professor

Model Details: The study will use a cluster-randomized, parallel-group design in which rehabilitation cohorts are randomized to one of two intervention arms. Clusters will remain in their assigned arm throughout the 4-week intervention.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 20, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 16, 2026

Record last verified: 2026-06