Stroke Rehabilitation Through Intensive Exercise

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

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-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.

Study Details

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.

Key Dates

First listed

Jun 16, 2026

Start date

Aug 1, 2026

Status verified

Jun 2026

Primary completion

Nov 20, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: LE-mCIMT- EXE
• Active Comparator: LE-mCIMT- TAU

Primary Outcome Measure

Fugl-Meyer Assessment for the lower extremity (LE-FMA) [ Time Frame: From enrollment to the end of the 4 week rehabilitation program ]

Central Contacts

• Maria Ekblom, professor
  0700039586
  [email protected]

Find similar trials

Related Studies

• Evaluation of an Advanced Lower Extremity Neuroprostheses
  Recruiting · Case Western Reserve University · Cleveland, Ohio
• Genetic and Environmental Risk Factors for Hemorrhagic Stroke
  Recruiting · State University of New York at Buffalo · Chicago, Illinois
• A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
  Recruiting · University of Wisconsin, Madison · Madison, Wisconsin
• Human-Machine System for the H2 Lower Limb Exoskeleton
  Recruiting · University of Houston · Houston, Texas