Intensive Walking Therapy for Stroke Rehabilitation

(VIEWS-2 Trial)

Overseen By Chris Henderson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Botulinum toxin

Disqualifiers: Cardiovascular, Metabolic, Respiratory, Orthopedic, others

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

Compensation: Varies

Number of Visits: 30

Duration: 8-10 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different types and intensities of physical therapy to aid recovery after a stroke. Researchers aim to assess how these therapies impact walking, community mobility, and overall quality of life. The trial includes four therapy approaches, combining high or low intensity with general or walking-specific exercises, such as intensive walking therapy. It suits individuals who experienced a stroke 1-6 months ago, have difficulty using one side of their body, and can walk short distances with or without assistance. As an unphased trial, this study provides a unique opportunity to explore personalized recovery options and enhance quality of life after a stroke.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot receive physical therapy once baseline testing begins.

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

Research has shown that high-intensity, task-specific walking exercises are safe and beneficial for stroke recovery. Studies have found that these programs can improve walking speed, distance, and balance. Participants in high-intensity walking training during recovery demonstrated better walking and balance outcomes.

In general physical therapy, both high- and low-intensity treatments are well-tolerated. These include strengthening exercises, balance training, and cycling. Such therapies are generally low-risk and commonly used in physical rehabilitation programs.

Overall, these treatments aim to enhance movement and are considered safe for stroke survivors, with any side effects being minor and manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of walking-focused rehabilitation for stroke recovery in a way that's different from current standards. While traditional treatments often involve a mix of general physical therapy exercises, this trial investigates the impact of high-intensity walking sessions specifically. This focus on task-specific, high-intensity walking could lead to more pronounced improvements in mobility and cardiovascular health compared to broader, non-specific exercises. By honing in on walking as a core component of recovery, the trial could reveal new insights into optimizing stroke rehabilitation strategies.

What evidence suggests that this trial's treatments could be effective for stroke rehabilitation?

Research has shown that intense, focused walking exercises, which participants in this trial may receive, can greatly aid stroke recovery by improving walking ability and balance. One study found that adding high-intensity walking exercises during recovery led to better outcomes in walking and balance. Similarly, some participants in this trial will receive intense general physical therapy, which has also proven effective in aiding stroke recovery. Studies have found that these high-intensity programs can significantly enhance walking distance and balance. This evidence suggests that both focused walking exercises and general therapy, as tested in this trial, can be beneficial for stroke rehabilitation. ^{6 7 8 9 10}

Who Is on the Research Team?

George Hornby

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for individuals who had a stroke 1-6 months ago, can walk at least 10 meters with or without help but not faster than 1.0 m/s, and can follow simple commands. They must be able to sit unaided for over half a minute and have medical clearance to participate. People with severe heart issues, walking limitations before the stroke, or certain other health conditions cannot join.

Inclusion Criteria

I had a stroke between 1 to 6 months ago.

I can sit for more than 30 seconds without help or using my arms for support.

Provision of informed consent and medical clearance from a supervising physician or medical provider to participate

Exclusion Criteria

I have not received more than 50 units of botulinum toxin in any leg muscle above the knee.

I cannot undergo physical therapy after the initial tests start.

I do not have severe heart, lung, kidney, or metabolic conditions that limit my physical activity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 30 1-hour sessions of physical therapy interventions over approximately 2 months, focusing on varying intensities and task-specificity

8-10 weeks

30 visits (in-person)

Follow-up

Participants are monitored for changes in mobility function, gait speed, and quality of life after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-intensity, non-specific physical therapy interventions
• High-intensity, task-specific (i.e., walking) interventions
• Low-intensity, non-specific physical therapy interventions
• Low-intensity, task-specific physical therapy interventions

Trial Overview The study tests how well different physical therapy strategies work after a stroke. It compares high-intensity vs low-intensity exercises and task-specific (like walking) vs non-specific activities on patients' ability to move around and their quality of life.

How Is the Trial Designed?

Group I: High-intensity, task-specific (i.e., walking) interventions Experimental Treatment 1 Intervention

30 1-hour (hr) sessions of walking training targeting higher cardiovascular intensities over approximately 2 months

Group II: Low-intensity, non-specific physical therapy interventions Active Control 1 Intervention

30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting lower cardiovascular intensities over approximately 2 months

Group III: High-intensity, non-specific physical therapy interventions Active Control 1 Intervention

30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting higher cardiovascular intensities over approximately 2 months

Group IV: Low-intensity, task-specific physical therapy interventions Active Control 1 Intervention

30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting lower cardiovascular intensities over approximately 2 months

High-intensity, non-specific physical therapy interventions is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as High-intensity physical therapy for:

• Stroke rehabilitation
• Locomotor function improvement
• Community mobility enhancement

Approved in United States as Intensive rehabilitation for:

• Subacute stroke rehabilitation
• Improvement of walking ability
• Enhancement of quality of life

Approved in Canada as Task-specific physical therapy for:

• Post-stroke locomotor function recovery
• Community mobility improvement
• Quality of life enhancement

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

In a study involving 10 stroke patients, partial body weight support treadmill training (PBWSTT) at faster speeds (up to 2.0 mph) significantly improved stride characteristics and muscle activation in the affected limbs, indicating enhanced motor recovery during the acute phase post-stroke.

Training at the fastest speed resulted in greater perceived exertion and a more optimal gait pattern, suggesting that higher intensity training may be beneficial for improving walking ability after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partial body weight support treadmill training speed influences paretic and non-paretic leg muscle activation, stride characteristics, and ratings of perceived exertion during acute stroke rehabilitation. Burnfield, JM., Buster, TW., Goldman, AJ., et al.[2017]

In a study involving 18 elderly patients with higher-level gait disorders due to cerebral multi-infarct states, both treadmill re-training and conventional physiotherapy led to significant improvements in various gait measures, such as walking speed and step length, with a high statistical significance (P < 0.001).

There was no significant difference in the effectiveness of treadmill re-training compared to conventional physiotherapy, indicating that both approaches are equally beneficial for improving gait in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional physiotherapy and treadmill re-training for higher-level gait disorders in cerebrovascular disease. Liston, R., Mickelborough, J., Harris, B., et al.[2019]

In a study of 715 post-stroke patients, physical therapy (PT) primarily focused on gait activities, with even those with limited mobility spending 25% to 38% of their PT time on walking exercises during initial treatment sessions.

Despite improvements in patient mobility over time, only a small percentage of PT time (1.2%-5.2%) was dedicated to community mobility activities, indicating a gap in training for real-world mobility before discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy during stroke rehabilitation for people with different walking abilities. Latham, NK., Jette, DU., Slavin, M., et al.[2022]

A high-intensity task-oriented training program significantly improved gait speed and walking capacity in patients with subacute stroke compared to a low-intensity physiotherapy program, as shown by results from the 10-metre timed walking test and the six-minute walk test.

The study involved 44 stroke patients and demonstrated that while the high-intensity training was feasible and effective for improving gait, it did not show significant differences in balance measures, suggesting that future research should also assess physical fitness and energy expenditure during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. Outermans, JC., van Peppen, RP., Wittink, H., et al.[2022]

In a study of 22 stroke patients who began intensive gait-oriented rehabilitation an average of 8 days post-stroke, 16 patients were able to walk unassisted after 3 weeks, demonstrating significant improvements in mobility.

The rehabilitation program was well tolerated, with only three patients dropping out, and resulted in measurable enhancements in walking speed, muscle strength, and overall motor function, indicating its efficacy in early post-stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intensive gait-oriented physiotherapy during early acute phase of stroke. Peurala, SH., Airaksinen, O., Jäkälä, P., et al.[2019]

In a study involving 20 chronic stroke patients, a three-week gait-oriented physiotherapy program provided a total of 19 hours of instructed therapy and 28 hours of self-initiated training, emphasizing the importance of active practice in rehabilitation.

The combination of various training methods, including electromechanical gait trainers and self-initiated exercises, led to significant improvements in gait ability, highlighting the effectiveness of structured and diverse rehabilitation approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How much exercise does the enhanced gait-oriented physiotherapy provide for chronic stroke patients? Peurala, SH., Pitkänen, K., Sivenius, J., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10216461/

A Comprehensive Review of Physical Therapy Interventions ... The study found that VR training was equally as effective as CT in improving upper extremity function during the subacute phase after a stroke.

2. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.043650?doi=10.1161/STROKEAHA.124.043650

High-Dose, High-Intensity Stroke Rehabilitation: Why Aren't ... There is convergent evidence indicating that high-dose, high-intensity rehabilitation is effective for improving outcomes after stroke with large effect sizes ...

3. obrienphysicaltherapy.net obrienphysicaltherapy.net/blog/post-stroke-rehabilitation-outcomes-statistics-on-physical-therapy-effectiveness

Post-Stroke Rehabilitation Outcomes: Statistics on Physical ... This article explores statistical data, scientific studies, and meta-analyses to summarize the effectiveness of various physical therapy ...

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Factors Influencing the Delivery of Intensive Rehabilitation in ... A survey among American physical therapists highlighted the fact that physical therapists see the benefit of higher aerobic exercise in the stroke population; ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1565118/full

Effects of high-intensity exercise on rehabilitation ... Conclusion: High-intensity exercise significantly improves 6MWT and BBS in stroke patients, but does not significantly affect TUG, VO2peak, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8423140/

Development and Results of an Implementation Plan for High ... High-intensity gait training is recommended in stroke rehabilitation to improve gait speed, walking distance, and balance. However, identifying effective and ...

7. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.119.027450

Implementation of High-Intensity Stepping Training During ... Provision of high-intensity stepping training applied during inpatient rehabilitation resulted in significantly greater walking and balance outcomes.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3196659/

Gait training strategies to optimize walking ability in people ... Task-specific physical therapy for optimization of gait recovery in acute stroke patients. Arch Phys Med Rehabil. 1993;74(6):612–620. doi: 10.1016/0003-9993 ...

9. mdpi.com mdpi.com/2077-0383/14/15/5409

Implementing High-Intensity Gait Training in Stroke ... Results: HIT was delivered with improved fidelity during the implementation and competency phases, reflected by increased stepping and heart rate metrics. A ...

10. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.044596

Increasing Activity After Stroke: A Randomized Controlled ... The data demonstrate that gains in walking activity in those with chronic stroke occur following a targeted behavioral intervention integrating ...