Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility
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|ClinicalTrials.gov Identifier: NCT03891641|
Recruitment Status : Terminated (COVID-19 continues to prevent recruitment of people over the age of 65 years.)
First Posted : March 27, 2019
Results First Posted : November 2, 2020
Last Update Posted : November 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Behavioral: Treadwell Tredlr||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects will be randomized into a treadling group (n=15) or a control group (n=15). Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. The control group will be instructed to continue their normal daily activities.|
|Masking:||None (Open Label)|
|Masking Description:||No Masking|
|Official Title:||A Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility in Patients With Peripheral Arterial Disease|
|Actual Study Start Date :||June 1, 2019|
|Actual Primary Completion Date :||June 15, 2020|
|Actual Study Completion Date :||June 15, 2020|
Experimental: Treadling Group
Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks.
Behavioral: Treadwell Tredlr
Complete treadling exercise 3x per week (15 min sessions) for 6 weeks.
No Intervention: Control Group
Control Subjects continue their normal daily activities.
- Change in Overground Walking Speed After Intervention [ Time Frame: Baseline, 6 weeks ]Measured from the time taken to walk 6 meters.
- Change in 6-min Walk Distance [ Time Frame: Baseline, 6 weeks ]Measured from the distance walked in 6 minutes.
- Change in Stride Length [ Time Frame: Baseline, 6 weeks ]Measured using motion capture as the distance between heel markers across successive steps.
- Change in Peak Ankle Power [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891641
|United States, North Carolina|
|Applied Biomechanics Laboratory|
|Chapel Hill, North Carolina, United States, 27514|
|Principal Investigator:||Jason Franz, PhD||University of North Carolina, Chapel Hill|