Mechanisms of Walking Recovery After Stroke

• Sponsor: University of Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT02858349
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 17
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: No intervention; Behavioral: High-intensity interval training	N/A

Detailed Description

Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention using high-intensity interval training.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcomes Assessor was blinded to study design, including when participant was in control phase versus intervention phase
• Primary Purpose: Basic Science
• Official Title: Mechanisms of Walking Recovery After Stroke
• Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 4-week control period with no intervention and 4-weeks of high-intensity interval training	Behavioral: No intervention; No intervention; Behavioral: High-intensity interval training; High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods

Outcome Measures

Primary Outcome Measures

1. Walking Speed [Change from 4-weeks to 8-weeks]

   10-meter walk test

Secondary Outcome Measures

1. Gait Symmetry [baseline, 4 weeks, 8 weeks]

   Paretic step ratio

2. Metabolic Cost of Gait [baseline, 4 weeks, 8 weeks]

   oxygen consumption rate during comfortable speed gait

3. Aerobic Capacity [baseline, 4 weeks, 8 weeks]

   oxygen consumption rate during exercise testing

4. NIH Toolbox - Cognition Domain [baseline, 4 weeks, 8 weeks]

5. NIH Toolbox Standing Balance Test [baseline, 4 weeks, 8 weeks]

6. Stroke and Aphasia Quality of Life Scale [baseline, 4 weeks, 8 weeks]

7. Brain Locomotor Network Activation [baseline, 4 weeks, 8 weeks]

8. Brain Locomotor Network Connectivity [baseline, 4 weeks, 8 weeks]

9. Walking Capacity [baseline, 4 weeks, 8 weeks]

   6-minute walk test

10. Daily Walking Activity [baseline, 4 weeks, 8 weeks]

    activity monitor

11. Walking Speed [baseline, 4 weeks, 8 weeks]

    10-meter walk test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age 30-90 years

• unilateral stroke experienced >6 months prior to enrollment in middle cerebral artery (MCA) territory without complete disruption of the putamen on the lesion side

• walking speed <= 1.0 m/s on the 10 meter walk test

• able to walk 10m over ground with assistive devices as needed and no physical assistance

Exclusion Criteria:

• MRI incompatibility (e.g. metallic or electronic implants, severe claustrophobia)

• inability to perform mental imagery (time dependent motor imagery screening test [TDMI])

• evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test, or significant baseline ECG abnormalities that would make an exercise ECG uninterpretable

• recent (<3 months) cardiopulmonary hospitalization

• unable to communicate with investigators or correctly answer consent comprehension questions

• significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)

• severe lower extremity (LE) spasticity (Ashworth >2)

• recent (<3 months) illicit drug or alcohol abuse or significant mental illness

• major post-stroke depression (PHQ-9 ≥10) in the absence of medical management

• participating in physical therapy or another interventional research study;

• recent (<3 months) paretic LE botulinum toxin injection

• concurrent progressive neurologic disorder or other major medical, orthopedic or peripheral vascular conditions that would limit improvement

• pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati	Cincinnati	Ohio	United States	45267

Sponsors and Collaborators

• University of Cincinnati

Investigators

• Principal Investigator: Pierce Boyne, PT, DPT, NCS, University of Cincinnati

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 24, 2018

More Information

Publications

None provided.

• Responsible Party: Pierce Boyne, Assistant Professor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT02858349
• Other Study ID Numbers: 2016-1916
• First Posted: Aug 8, 2016
• Last Update Posted: Mar 15, 2019
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	Arm 1
Arm/Group Description	4-week control period with no intervention and 4-weeks of high-intensity interval training No intervention: No intervention High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Arm 1
Arm/Group Description	4-week control period with no intervention and 4-weeks of high-intensity interval training No intervention: No intervention High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.8 (6.8)
Sex: Female, Male (Count of Participants)
Female	4 40%
Male	6 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	10 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 30%
White	7 70%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%
Comfortable Gait Speed, m/s (meters per second) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters per second]	0.41 (0.33)
Stroke Chronicity (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	2.4 (1.7)

Outcome Measures

1. Primary Outcome

Title	Walking Speed
Description	10-meter walk test
Time Frame	Change from 4-weeks to 8-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	4-week control period with no intervention and 4-weeks of high-intensity interval training No intervention: No intervention High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods
Measure Participants	10
Least Squares Mean (95% Confidence Interval) [meters per second]	0.13

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm 1
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0042
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95%; 0.05 to 0.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Gait Symmetry
Description	Paretic step ratio
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Metabolic Cost of Gait
Description	oxygen consumption rate during comfortable speed gait
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Aerobic Capacity
Description	oxygen consumption rate during exercise testing
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	NIH Toolbox - Cognition Domain
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	NIH Toolbox Standing Balance Test
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Stroke and Aphasia Quality of Life Scale
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Brain Locomotor Network Activation
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Brain Locomotor Network Connectivity
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Walking Capacity
Description	6-minute walk test
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Daily Walking Activity
Description	activity monitor
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Walking Speed
Description	10-meter walk test
Time Frame	baseline, 4 weeks, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months.
Adverse Event Reporting Description	Each study visit, participant voluntary reporting of adverse events (AEs) was encouraged and AEs of interest were specifically queried, including: falls, orthopedic injuries, faintness, new/increased pain and muscle soreness. During clinical testing and training sessions, participants also had monitoring and post-session questioning to identify any signs or symptoms of cardiorespiratory insufficiency, new/worsening neurological impairments or orthopedic injury.
Arm/Group Title	Arm 1
Arm/Group Description	4-week control period with no intervention and 4-weeks of high-intensity interval training No intervention: No intervention High-intensity interval training: High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods
All Cause Mortality
	Arm 1
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	8/10 (80%)
Infections and infestations
Infection	1/10 (10%)	1
Musculoskeletal and connective tissue disorders
Fall	5/10 (50%)	11
Joint stiffness	1/10 (10%)	1
Increased knee hyperextension	1/10 (10%)	1
Pain/soreness	7/10 (70%)	24
Surgical procedure	1/10 (10%)	1
Nervous system disorders
Dizziness	4/10 (40%)	11
Fatigue	2/10 (20%)	3
Headache	2/10 (20%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.