Trial Outcomes & Findings for Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility (NCT NCT03891641)

NCT ID: NCT03891641

Last Updated: 2020-11-02

Results Overview

Measured from the time taken to walk 6 meters.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: Baseline, 6 weeks
• Results posted on: 2020-11-02

Participant Flow

Participant milestones

Measure	Treadling Group Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.	Control Group Control Subjects continue their normal daily activities.
Overall Study STARTED	10	7
Overall Study COMPLETED	8	5
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Treadling Group Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.	Control Group Control Subjects continue their normal daily activities.
Overall Study Study Stoppage Due to COVID-19	2	2

Baseline Characteristics

Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility

Baseline characteristics by cohort

Measure	Treadling Group n=10 Participants Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.	Control Group n=7 Participants Control Subjects continue their normal daily activities.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	72.6 years STANDARD_DEVIATION 5.4 • n=5 Participants	71.3 years STANDARD_DEVIATION 5.2 • n=7 Participants	72.2 years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks

Measured from the time taken to walk 6 meters.

Outcome measures

Measure	Treadling Group n=8 Participants Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.	Control Group n=5 Participants Control Subjects continue their normal daily activities.
Change in Overground Walking Speed After Intervention	-0.046 m/s Standard Deviation 0.099	0.022 m/s Standard Deviation 0.140

PRIMARY outcome

Timeframe: Baseline, 6 weeks

Measured from the distance walked in 6 minutes.

Outcome measures

Measure	Treadling Group n=8 Participants Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.	Control Group n=5 Participants Control Subjects continue their normal daily activities.
Change in 6-min Walk Distance	13.60 m Standard Deviation 52.60	16.04 m Standard Deviation 38.40

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Measured using motion capture as the distance between heel markers across successive steps.

Outcome measures

Measure	Treadling Group n=8 Participants Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.	Control Group n=5 Participants Control Subjects continue their normal daily activities.
Change in Stride Length	0.005 m Standard Deviation 0.075	-0.014 m Standard Deviation 0.016

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Measured using motion capture and instrumented treadmill forces as the peak positive power generated by the calf muscles during the push-off phase of walking.

Outcome measures

Measure	Treadling Group n=8 Participants Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.	Control Group n=5 Participants Control Subjects continue their normal daily activities.
Change in Peak Ankle Power	-0.294 W/kg Standard Deviation 0.630	0.088 W/kg Standard Deviation 0.255

Adverse Events

Treadling Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jason R Franz, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-6119

Email: jrfranz@email.unc.edu

Results disclosure agreements

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