Trial Outcomes & Findings for Mechanisms of Walking Recovery After Stroke (NCT NCT02858349)

NCT ID: NCT02858349

Last Updated: 2019-03-15

Results Overview

10-meter walk test

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Change from 4-weeks to 8-weeks
• Results posted on: 2019-03-15

Participant Flow

Participant milestones

Measure	Arm 1 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 Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mechanisms of Walking Recovery After Stroke

Baseline characteristics by cohort

Measure	Arm 1 n=10 Participants 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
Age, Continuous	59.8 years STANDARD_DEVIATION 6.8 • n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	7 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants
Comfortable Gait Speed, m/s	0.41 meters per second STANDARD_DEVIATION 0.33 • n=93 Participants
Stroke Chronicity	2.4 years STANDARD_DEVIATION 1.7 • n=93 Participants

PRIMARY outcome

Timeframe: Change from 4-weeks to 8-weeks

10-meter walk test

Outcome measures

Measure	Arm 1 n=10 Participants 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
Walking Speed	0.13 meters per second Interval 0.05 to 0.21

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

Paretic step ratio

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

oxygen consumption rate during comfortable speed gait

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

oxygen consumption rate during exercise testing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

6-minute walk test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

activity monitor

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 4 weeks, 8 weeks

10-meter walk test

Outcome measures

Outcome data not reported

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm 1 n=10 participants at risk 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
Nervous system disorders Dizziness	40.0% 4/10 • Number of events 11 • Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months. 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.
Musculoskeletal and connective tissue disorders Fall	50.0% 5/10 • Number of events 11 • Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months. 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.
Nervous system disorders Fatigue	20.0% 2/10 • Number of events 3 • Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months. 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.
Nervous system disorders Headache	20.0% 2/10 • Number of events 2 • Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months. 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.
Infections and infestations Infection	10.0% 1/10 • Number of events 1 • Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months. 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.
Musculoskeletal and connective tissue disorders Joint stiffness	10.0% 1/10 • Number of events 1 • Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months. 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.
Musculoskeletal and connective tissue disorders Increased knee hyperextension	10.0% 1/10 • Number of events 1 • Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months. 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.
Musculoskeletal and connective tissue disorders Pain/soreness	70.0% 7/10 • Number of events 24 • Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months. 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.
Musculoskeletal and connective tissue disorders Surgical procedure	10.0% 1/10 • Number of events 1 • Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months. 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.

Additional Information

Pierce Boyne

University of Cincinnati

Phone: 5135587499

Email: Pierce.Boyne@uc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place