Multiple Sclerosis (MS) Relapsing Remitting
Conditions
Keywords
Multiple sclerosis, gait, exoskeleton, hip flexion orthosis
Brief summary
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?
Detailed description
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).
Interventions
DEVICEPowered Hip Flexion Orthosis (Hypershell X)
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.
Sponsors
University of Dayton
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an exploratory case series
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Waist circumference 26-48", Height 5 '- 6'2", Weight 100-230lbs
Exclusion criteria
* 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. * Any other neurological conditions that may affect gait.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait speed | Day 1 (immediate effect of device use) | Gait speed measured during a 10 meter walk |
| Foot clearance | Day 1 (immediate effect of device use) | Distance that the foot clears the ground during the swing phase of gait |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Step length | 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 |
| Circumduction | Day 1 (immediate effect of device use) | Lateral excursion of of the foot during mid swing |
| Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) | 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. |
Countries
United States
Contacts
CONTACTKurt Jackson, PhD
Outcome results
None listed