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

Trial Summary

What is the purpose of this trial?

The proposed research will evaluate the individual and combined effects of task-specificity and intensity of rehabilitation interventions on locomotor function, community mobility and quality of life in patients with subacute (1-6 months) post-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 intensive walking therapy safe for stroke rehabilitation?

Research on intensive walking therapy for stroke rehabilitation suggests it is generally safe for humans, as studies focus on its feasibility and effects on walking performance without reporting significant safety concerns. ^{1 2 3 4 5}

How is the Intensive Walking Therapy treatment different from other stroke rehabilitation treatments?

Intensive Walking Therapy is unique because it focuses on high-intensity, task-specific training, such as walking, which is designed to improve walking ability by incorporating a high cardiovascular workload and a large number of repetitions. This approach is different from standard physical therapy as it emphasizes early, intensive, and specific gait-oriented exercises to promote neural changes and improve motor function after a stroke. ^{1 2 3 4 6}

Research Team

George Hornby

Principal Investigator

Indiana University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. [2022]

2. Netherlands 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. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Physical therapy during stroke rehabilitation for people with different walking abilities. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

How much exercise does the enhanced gait-oriented physiotherapy provide for chronic stroke patients? [2016]

5. England pubmed.ncbi.nlm.nih.gov

Conventional physiotherapy and treadmill re-training for higher-level gait disorders in cerebrovascular disease. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of intensive gait-oriented physiotherapy during early acute phase of stroke. [2019]