Clinical Investigation to Validate the Safety and Performance of the A

Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting

CompletedNot a drug-phase studyMS (type not specified)NCT06261541

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • ABLE Exoskeleton

What it measured

Main measures

  • Number and type of device-related Adverse Events

    Up to 16 weeks

    Safety

  • Level of Assistance (LoA) to don/doff the device

    Up to 11 weeks

  • Time taken to don/doff the device

    Up to 11 weeks

  • Level of Assistance (LoA) to complete therapy activity tasks

    Up to 11 weeks

    Walking and mobility

  • Time spent upright and time spent walking

    Up to 11 weeks

    Walking and mobility

  • Number of steps walked

    Up to 11 weeks

    Walking and mobility

  • Distance walked

    Up to 11 weeks

    Walking and mobility

Other measures (13)

  • Timed 25-Feet Walk test (T25FW)

    Up to 11 weeks

    Disability progressionWalking and mobility

  • Ambulation Index (AI)

    Up to 11 weeks

    Walking and mobility

  • 6-Minute Walk Test (6MWT)

    Up to 11 weeks

    Walking and mobility

  • Timed Up-and-Go test (TUG)

    Up to 11 weeks

    Walking and mobility

  • Trunk Impairment Scale (TIS)

    Up to 11 weeks

    Walking and mobility

  • Lower extremity muscle strenght

    Up to 11 weeks

    Physical function

  • Modified Ashworth Scale (MAS)

    Up to 11 weeks

    MRI lesionsSpasticity

  • Borg Rating of Perceived Exertion

    Up to 11 weeks

    FatiguePhysical function

  • Barthel Index (BI) score

    Up to 11 weeks

    Walking and mobility

  • Modified Fatigue Impact Scale (MFIS) score

    Up to 11 weeks

    Thinking and memoryFatigue

Who could take part

MS (type not specified) · 18 to 70

Show the full 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.

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

About this trial

In the sponsor's words

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.

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History

    1. Started

      Apr 2024

    2. Main results due

      Jul 2024

    3. Finished

      Jul 2024

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