Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton i

Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT06921551

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • ABLE Exoskeleton

What it measured

Main measures

  • Number of therapeutic objectives achieved

    From baseline to the end of the training program at 12 months

  • Lower extremity muscle strenght

    Baseline, 3, 6, and 12 months post-training

    Walking and mobilityPhysical function

  • Modified Ashworth Scale (MAS)

    Baseline, 3, 6, and 12 months post-training

    MRI lesionsWalking and mobilitySpasticity

  • Location and level of pain

    Baseline, 3, 6, and 12 months post-training

    Walking and mobilityPain

  • Timed 25-Feet Walk test (T25FW)

    Baseline, 3, 6, and 12 months post-training

    Disability progressionWalking and mobility

  • 6-Minute Walk Test (6MWT)

    Baseline, 3, 6, and 12 months post-training

    Walking and mobility

  • Borg Rating of Perceived Exertion

    Baseline, 3, 6, and 12 months post-training

    FatigueWalking and mobilityPhysical function

  • Trunk Impairment Scale (TIS)

    Baseline, 3, 6, and 12 months post-training

    Walking and mobility

  • Barthel Index (BI) score

    Baseline, 3, 6, and 12 months post-training

    Walking and mobility

  • Modified Fatigue Impact Scale (MFIS) score

    Baseline, 3, 6, and 12 months post-training

    Thinking and memoryFatigueWalking and mobility

  • Multiple Sclerosis Quality of Life-54 (MSQoL-54) scores

    Baseline, 3, 6, and 12 months post-training

    Walking and mobilityQuality of life (reported by participants)

  • Self-perceived impact on general health status

    3, 6, and 12 months post-training

    SpasticityBladder, bowel and sexual functionPainMood and sleep

  • Level of motivation

    After 12 months post-training

  • Psychosocial Impact of Assistive Devices Scale (PIADS) score

    After 12 months post-training

    Quality of life (reported by participants)

  • Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score

    After 12 months post-training

    Quality of life (reported by participants)

Other measures (3)

  • Time spent upright and time spent walking

    At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10

    Walking and mobility

  • Number of steps walked

    At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10

    Walking and mobility

  • Distance walked

    At session 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10

    Walking and mobility

Who could take part

MS (type not specified) · 18 to 70

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

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History

    1. Started

      Apr 2025

    2. Main results due

      May 2026

    3. Finished

      May 2026

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