CIMT vs Treadmill Training for Post-Stroke Walking Recovery

Overseen By Weena Dee, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Cardiorespiratory disease, Neurological injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 6 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two therapies to improve walking after a stroke. One group will use Constraint Induced Movement Therapy (CIMT), which trains the weaker side of the body. The other group will undergo treadmill training with assistance for the affected leg. The goal is to determine which method more effectively improves walking. This trial suits individuals who have experienced a single stroke, have difficulty walking, and can walk at least 10 meters unassisted. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance rehabilitation methods for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both Constraint Induced Movement Therapy (CIMT) and treadmill training are generally safe for people recovering from a stroke. Studies indicate that CIMT can enhance movement skills and balance with only minor side effects. This therapy safely aids stroke patients in regaining movement in their affected limbs.

Similarly, treadmill training is well-tolerated and often used in stroke recovery to improve walking. Reports suggest it can be safely combined with other treatments. Both therapies have a good safety record, making them promising options for those seeking to improve walking after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for post-stroke walking recovery because they offer innovative approaches to rehabilitation. Unlike traditional physical therapy, which focuses on general mobility exercises, robotic training uses controlled resistance and assistance loads to target specific muscles, potentially enhancing recovery efficiency. Meanwhile, treadmill training incorporates manual assistance to the affected leg, offering tailored support during movement to improve gait mechanics. These techniques could provide more personalized and effective options for individuals recovering from a stroke, potentially accelerating their progress compared to standard methods.

What evidence suggests that this trial's treatments could be effective for post-stroke walking recovery?

This trial will compare Constraint Induced Movement Therapy (CIMT) with treadmill training for post-stroke walking recovery. Research shows that CIMT can significantly enhance walking ability and movement in stroke recovery. Studies have found that CIMT outperforms some traditional therapies in improving balance and leg function, at least in the short term. Meanwhile, treadmill training, another treatment option in this trial, has increased walking speed and stamina in stroke survivors. It helps individuals walk faster and enhances mobility, making it a strong choice for post-stroke recovery. Both treatments offer promising ways to improve walking after a stroke. ^{2 4 6 7 8}

Who Is on the Research Team?

Ming Wu, PhD

Principal Investigator

Abilitylab

Are You a Good Fit for This Trial?

This trial is for individuals aged 21-75 who have had a stroke and now walk slower than usual (≤ 0.80 m/s). They must be able to stand and take steps without help but can't join if they have serious heart/lung diseases, other injuries affecting walking, poor mental function scores, certain types of strokes, very high blood pressure, or recent Botox injections.

Inclusion Criteria

I can walk more than 10 meters without help.

I have had a stroke in the upper part of my brain.

I am between 21 and 75 years old.

Exclusion Criteria

My blood pressure is not higher than 200/110 mm Hg.

I have a nerve or bone injury that affects my ability to move.

I have had a stroke in the brainstem or have cerebellar lesions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intensive locomotor training with either CIMT or treadmill training, 3 times per week for 6 weeks

6 weeks

18 visits (in-person)

Follow-up

Participants are monitored for changes in walking distance, balance, and speed 8 weeks after the end of training

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Constraint Induced Movement Therapy
• Treadmill Training

Trial Overview The study is testing two ways to improve walking after a stroke: constraint induced movement therapy (CIMT) versus treadmill training alone. Participants will be randomly placed in one of the groups and train three times a week for six weeks to see which method helps more with their walking ability.

How Is the Trial Designed?

Group I: robotic training Experimental Treatment 1 Intervention

For the robotic training group, a controlled resistance load will be applied to the unaffected leg at the ankle and an assistance load will be applied to the pelvis.

Group II: treadmill training Active Control 1 Intervention

For the treadmill training only group, a physical therapist will provide manual assistance to the affected leg at the knee and/or ankle joints as necessary during treadmill training.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10171361/

Lower-extremity constraint-induced movement therapy ... A highly intensive CIMT for lower extremity (LE-CIMT) function post-stroke can improve motor function, functional mobility, and walking ability.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666337625000678

Modified constraint-induced movement therapy for lower ... Studies show that mCIMT improves motor function, functional mobility, balance, lower limb strength, weight-bearing, and walking ability with minor side effects.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8949312/

Effectiveness of Constraint-Induced Movement Therapy (CIMT ... These findings indicate that CIMT interventions can improve balance-related motor function better than neuro developmental treatment, modified ...

4. ahajournals.org ahajournals.org/doi/10.1161/01.str.30.3.586

Effects of Constraint-Induced Movement Therapy on ... It is estimated that patients amenable to substantial improvement as a result of CI therapy represent at least 50% of the total stroke population. Most of the ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1090808/full

Influence of the constraint-induced method ... Constraint-induced movement therapy is superior to conventional treatment for improvement of lower limb function in the short-term but not in the long-term.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10151521/

The effect and safety of constraint-induced movement ... CIMT may be an optional and safe rehabilitation therapy to improve PSMD. However, due to limited studies, the optimal protocol of CIMT for PSMD ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11211381/

Global research hotspots and trends in constraint-induced ... Improvement of motor function in stroke patients through various forms of constraint-induced movement therapy (CITM) has been recognized as safe ...

8. researchprotocols.org researchprotocols.org/2025/1/e68340

Constraint-Induced Movement Therapy With or Without ... Objective: In this randomized controlled trial, we aim to determine the effectiveness of CIMT combined with NMES, CIMT alone, and conventional ...