Promoting Recovery Optimization With WALKing Exercise After Stroke

Stroke Clinical Trial

— PROWALKS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835313
• Other study ID #: NIH 1R01HD086362-01A1
• Status: Completed
• Phase: N/A
• Start date: July 18, 2016
• Est. completion date: December 2023

Study information

• Verified date: March 2024
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stroke survivors, as a group, are extremely inactive and this has serious consequences for them, including an increased risk of a second stroke and developing other diseases. This study investigates a novel intervention designed to improve everyday activity after stroke by combining walking training to improve walking capacity with a program to encourage more daily walking.

Description:

As a group, stroke survivors are more physically inactive than even the most sedentary older adults. Lack of physical activity has serious consequences in persons with stroke, including an increased risk of recurrent stroke, developing other diseases and mortality. Current rehabilitation interventions do little to improve real-world walking activity after stroke, suggesting that simply improving walking capacity is not sufficient for improving daily physical activity after stroke. Rather, the investigator's hypothesize that the combination of a fast walking intervention that improves walking capacity, with a step activity monitoring program that facilitates translation of gains from the clinic to the "real-world", would generate greater improvements in real world walking activity than with either intervention alone. Data from the investigator's lab provides support for this hypothesis; however, it suggests that the greater efficacy of combining the 2 interventions depends on a participant's initial walking activity. Thus, the investigator's do not expect that one intervention will be superior to the others for all participants, but rather that the combined intervention will be superior for those with low levels of baseline walking activity, speed and endurance. The specific objective of this study is to test whether and for whom combining fast walking training with a step activity monitoring program (FAST+SAM) is superior in improving real-world walking activity compared to fast walking training alone (FAST) or a step activity monitoring and feedback program alone (SAM) in those with chronic stroke. Using a randomized controlled experimental design, 225 chronic (> 6 months) stroke survivors, will complete 12 weeks of fast walking training (FAST), a step activity monitoring program (SAM) or a fast walking training + step activity monitoring program (FAST+SAM). Moderation of specific intervention outcomes by baseline characteristics will be evaluated to determine for whom the interventions are effective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age 21-85

2. Chronic stroke (>6 months post stroke)

3. Able to walk at self-selected speed without assistance from another person (assistive devices are allowed)

4. Self-selected walking speed >0.3 m/s and <1.0 m/s

5. Average steps/day <8,000

6. Resting heart rate between 40-100 beats per minute

7. Resting blood pressure between 90/60 to 170/90.

Exclusion Criteria:

1. Evidence of cerebellar stroke

2. Other potentially disabling neurologic conditions in addition to stroke

3. Lower limb Botulinum toxin injection <4 months earlier

4. Current participation in physical therapy

5. Inability to walk outside the home prior to the stroke

6. Coronary artery bypass graft, stent placement or myocardial infarction within past 3 months

7. Musculoskeletal pain that limits activity

8. Inability to communicate with investigators

9. score >1 on question 1b and >0 on question 1c on the NIH Stroke Scale.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• FAST
Subjects participate in fast walking training 3x/week for 12 weeks.
• FAST+SAM
Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks
• SAM
Subjects participate in a step activity monitoring program 3x/week for 12 weeks

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (4)

Lead Sponsor	Collaborator
University of Delaware	Christiana Care Health Services, Indiana University, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steps per day		3 months (Post), 6 months, 12 months
Secondary	walking speed as measured by the 10 meter walk test		3 months (Post), 6 months, 12 months
Secondary	endurance as measured by the 6 minute walk test		3 months (Post), 6 months, 12 months
Secondary	oxygen consumption		3 months (Post), 6 months, 12 months