Clinical trial NCT06261541: Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting
Official title: Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Lower-limb exoskeleton
Gait training
Lead sponsor: ABLE Human Motion S.L.
Sponsor class: INDUSTRY
Collaborators: name: Fundación Esclerosis Múltiple Madrid (FEMM)
First posted: 2024-02-15
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. Furthermore, the potential effects of the training on walking, and balance function, general health status, user satisfaction, and quality of life will be assessed.

Detailed description: This is a pre-post, single-center, quasi-experimental study with an estimated duration of 4 months since the approval date. The study will be conducted at the Fundación Esclerosis Múltiple de Madrid (FEMM), where a minimum of 20 participants are expected to be recruited over a maximum period of 2 months since the approval date.

After obtaining informed consent, through the Patient Information Sheet and the Informed Consent Form, the selection of the participants will be carried out to determine their inclusion in the study. Subjects who do not meet all the inclusion and exclusion criteria during the screening visit will be excluded from the study. At the latest, one week after the screening visit, the participants will undergo a preliminary assessment without the medical device.

Participants will undergo a 10-session training program with the ABLE Exoskeleton device for a maximum duration of 11 weeks. Sessions will be conducted 1 to 2 times per week, depending on the participant's availability. Each session will last approximately 60 minutes. During the training period, session data will be taken to assess the safety and clinical performance of the device. At the latest, one week after the last training session, a post-training assessment will be performed. Finally, two weeks after the last training session, a follow-up assessment will be made to the participants via a telephone call to review any adverse events (AE) reported between the end of the training and the follow-up.

This is the first study investigating the use of the ABLE Exoskeleton in people with MS, therefore the primary hypothesis of this study is that the ABLE Exoskeleton is safe and has adequate performance for the intended MS population in a clinical setting. The secondary hypothesis is that the device will have a positive impact on the muscular strength, spasticity, perceived rate of exertion, mobility, satisfaction, and quality of life of the study participants.

Eligibility criteria: Inclusion Criteria:

* 18 to 70 years of age.
* Diagnosed with MS.
* Currently receiving treatment as an inpatient or outpatient at one of the investigational site.
* Ability to give informed consent.

Exclusion Criteria:

* Significant osteoporosis that may increase the risk of fracture.
* Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years.
* Spinal instability (or spinal orthoses, unless authorized by a physician).
* Severe spasticity: Level 4 on the Modified Ashworth Scale.
* Orthostatic hypotension. Inability to tolerate a minimum of 30 minutes of standing.
* Uncontrolled autonomic dysreflexia.
* Medically unstable
* Unstable cardiovascular system (CVS), hemodynamic instability, untreated hypertension (SBP\>140, DBP\>90 mmHg), unresolved deep venous thrombosis (DVT).
* Serious comorbidities, including any condition that a physician deems inappropriate for use of the ABLE Exoskeleton or to complete participation in the study.
* Skin integrity problems on the contact surfaces of the device or that would prevent sitting.
* Grade I or higher on EPUAP (European Pressure Ulcer Advisory Panel, 2019) on areas that will be in contact with the exoskeleton.
* Colostomy.
* Anthropometric measurements outside the values compatible with ABLE Exoskeleton. In particular, height not between 1.5-1.9 m, or weight over 100 kg.
* Anatomical constraints (such as eg length differences, users unable to position themselves inside the device) that are incompatible with the device.
* Restrictions in range of motion that prevent normal gait from being achieved or preventing the completion of a normal transition from sitting to standing or standing to sitting.
* Heterotopic ossification
* Known pregnancy or breastfeeding
* Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures.

Primary outcomes:
measure: Number and type of device-related Adverse Events
timeFrame: Up to 16 weeks
measure: Level of Assistance (LoA) to don/doff the device
timeFrame: Up to 11 weeks
measure: Time taken to don/doff the device
timeFrame: Up to 11 weeks
measure: Level of Assistance (LoA) to complete therapy activity tasks
timeFrame: Up to 11 weeks
measure: Time spent upright and time spent walking
timeFrame: Up to 11 weeks
measure: Number of steps walked
timeFrame: Up to 11 weeks
measure: Distance walked
timeFrame: Up to 11 weeks
Secondary outcomes:
measure: Timed 25-Feet Walk test (T25FW)
timeFrame: Up to 11 weeks
measure: Ambulation Index (AI)
timeFrame: Up to 11 weeks
measure: 6-Minute Walk Test (6MWT)
timeFrame: Up to 11 weeks
measure: Timed Up-and-Go test (TUG)
timeFrame: Up to 11 weeks
measure: Trunk Impairment Scale (TIS)
timeFrame: Up to 11 weeks
measure: Lower extremity muscle strenght
timeFrame: Up to 11 weeks
measure: Modified Ashworth Scale (MAS)
timeFrame: Up to 11 weeks
measure: Borg Rating of Perceived Exertion
timeFrame: Up to 11 weeks
measure: Barthel Index (BI) score
timeFrame: Up to 11 weeks
measure: Modified Fatigue Impact Scale (MFIS) score
timeFrame: Up to 11 weeks
measure: Multiple Sclerosis Quality of Life-54 (MSQoL-54)
timeFrame: Up to 11 weeks
measure: Psychosocial Impact of Assistive Devices Scale (PIADS) score
timeFrame: Up to 11 weeks
measure: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score
timeFrame: Up to 11 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundación Esclerosis Múltiple Madrid (FEMM)
Study officials:
References: