University of Dayton
Dayton, Ohio, 45469, United States
NCT Number: NCT07724093
The purpose of this study is to assess the immediate effects of a commercially available non-FDA regulated powered hip flexion assist device (Hypershell X, Shenzhen, China) on walking ability in persons with MS. The main question it aims to answer is: Does a powered hip flexion device provide immediate improvements in walking ability over short distances for people with MS?
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Dayton, Ohio, 45469, United States
Individuals with multiple sclerosis (MS) frequently experience problems with walking that may include difficulty with advancing the leg during the swing phase of gait which can lead to a loss of independence and a higher risk of falls. To improve walking ability in this population, devices such as ankle-foot orthoses (AFO) and functional electrical stimulation (FES) are commonly used. However, recent advances in technology and robotics have led to the development of affordable and commercially available battery powered exoskeletons marketed towards improving activities such as hiking, running and cycling. There is emerging but limited evidence that hip flexion-assisting devices can modify kinematics and muscle activity during gait in people with MS, with several small-scale studies showing tolerability and shifts toward more normal hip motion during walking. However, there are no studies on the use of new commercially available powered hip flexion assist devices. Therefore, the purpose of this case series is to assess the immediate effects on walking ability of a commercially available, non-FDA regulated, powered hip flexion assist device (Hypershell X, Shenzhen, China).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will perform a series of 10 meters walks while wearing the hip flexion assist device under the following conditions. 1) No assistance (passive mode) 2) 25% power assistance 3) 50% power assistance 4) 75% power assistance During the trial subjects will wear motion sensors that provide the following gait parameters: speed, step and stride length, foot clearance, foot angle at heel strike, circumduction, single and double support time.
Time frame: Day 1 (immediate effect of device use)
Gait speed measured during a 10 meter walk
Time frame: Day 1 (immediate effect of device use)
Distance that the foot clears the ground during the swing phase of gait
Time frame: Day 1 (immediate effect of device use)
Step length as measured from heel strike of the one foot to heel strike of the other foot
Time frame: Day 1 (immediate effect of device use)
Lateral excursion of of the foot during mid swing
Time frame: Day 1 (immediate effect of device use)
The purpose of the QUEST 2.0© questionnaire is to evaluate satisfaction with assistive device use. The questionnaire consists of 12 satisfaction items. Participants will rate their satisfaction with the Hypershell device using a scale of 1 to 5.
Contact information is provided by the study sponsor or research team.
University of Dayton
Other
The Effects of a Powered Hip Flexion Orthosis on Gait in Persons With Multiple Sclerosis: a Case Series
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