Effects of Powered Hip Flexion Device in Persons With Multiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Dayton
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80
Diagnosis of relapsing remitting, primary progressive or secondary progressive MS
Unilateral or bilateral hip flexion weakness (Manual muscle testing score of 3 or less)
Ability to walk at least 30 meters without requiring rest and without physical support or assistance from another person.
Disqualifiers
Prior regular use of a hip flexion orthosis within the past 6 months.
Cognitive or communication deficits that would limit ability to participate safely.
Significant pain or deformity of the lower extremities that could impact walking ability.
Severe spasticity (Modified Ashworth Score of 3 or 4) of the hips or lower extremities that could impact walking ability.
Trial design
Design model
Single group
Treatments tested in this trial
Powered Hip Flexion Orthosis (Hypershell X)
DeviceParticipants 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Hip flexion assistExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gait speed
Gait speed measured during a 10 meter walk
Time frame
Day 1 (immediate effect of device use)2
Foot clearance
Distance that the foot clears the ground during the swing phase of gait
Time frame
Day 1 (immediate effect of device use)Secondary outcomes
1
Step length
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)2
Circumduction
Lateral excursion of of the foot during mid swing
Time frame
Day 1 (immediate effect of device use)3
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
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.
Time frame
Day 1 (immediate effect of device use)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: