Clinical trial NCT06921551: Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis
Official title: Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Gait training
Wearable exoskeleton
Multiple Sclerosis
Lead sponsor: ABLE Human Motion S.L.
Sponsor class: INDUSTRY
Collaborators: name: Fundación Esclerosis Múltiple Madrid (FEMM)
First posted: 2025-04-10
Enrollment: 20
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: SUPPORTIVE_CARE

Brief summary: The goal of this study is to explore the potential clinical benefits of the ABLE Exoskeleton as part of a rehabilitation program in people with multiple sclerosis. The main question it aims to answer is:

Can a rehabiliation program with the ABLE Exoskeleton help to mantain the physical and psychosocial health of people with multiple sclerosis?

Participants will:

* Have a gait training session of 60 min with the exoskeleton once a week for 12 months at the clinic
* Have an evaluation (tests and questionnaires) every 3 months at the clinic


Eligibility criteria: Inclusion Criteria:

* 18 to 70 years old
* Diagnosed with multiple sclerosis
* Currently undergoing outpatient physical therapy treatment at the investigation 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 standing
* Uncontrolled autonomic dysreflexia
* Medical instability
* 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 of therapeutic objectives achieved
timeFrame: From baseline to the end of the training program at 12 months
measure: Lower extremity muscle strenght
timeFrame: Baseline, 3, 6, and 12 months post-training
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline, 3, 6, and 12 months post-training
measure: Location and level of pain
timeFrame: Baseline, 3, 6, and 12 months post-training
measure: Timed 25-Feet Walk test (T25FW)
timeFrame: Baseline, 3, 6, and 12 months post-training
measure: 6-Minute Walk Test (6MWT)
timeFrame: Baseline, 3, 6, and 12 months post-training
measure: Borg Rating of Perceived Exertion
timeFrame: Baseline, 3, 6, and 12 months post-training
measure: Trunk Impairment Scale (TIS)
timeFrame: Baseline, 3, 6, and 12 months post-training
measure: Barthel Index (BI) score
timeFrame: Baseline, 3, 6, and 12 months post-training
measure: Modified Fatigue Impact Scale (MFIS) score
timeFrame: Baseline, 3, 6, and 12 months post-training
measure: Multiple Sclerosis Quality of Life-54 (MSQoL-54) scores
timeFrame: Baseline, 3, 6, and 12 months post-training
measure: Self-perceived impact on general health status
timeFrame: 3, 6, and 12 months post-training
measure: Level of motivation
timeFrame: After 12 months post-training
measure: Psychosocial Impact of Assistive Devices Scale (PIADS) score
timeFrame: After 12 months post-training
measure: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score
timeFrame: After 12 months post-training
Secondary outcomes:
measure: Time spent upright and time spent walking
timeFrame: At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10
measure: Number of steps walked
timeFrame: At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10
measure: Distance walked
timeFrame: At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundación Esclerosis Múltiple Madrid (FEMM)
Study officials:
References: