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

NCT06261541 | Completed

• 1 other identifier: ABLEexoMS
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Lower-limb exoskeleton; Gait training

Outcome Measures

Primary Outcomes (7)

• Number and type of device-related Adverse Events

  To assess safety, the number of Severe Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported.

  Up to 16 weeks

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

  Level of Assistance (LoA) to don/doff the device will be measured in every session. The level of assistance will be measured using a 6-item scale, from Total assistance to Independence, with Independence being the best outcome possible. Different assistance levels are defined taking into account the degree of participation of both the participant and the therapist on performing the activity.

  Up to 11 weeks

• Time taken to don/doff the device

  The time taken to don/doff the device will be measured in every session. Time will be measured in minutes and seconds for each activity. Donning time will start from the moment the participant is ready to transfer into the device until all the straps and clips are correctly tightened. Doffing time will start from the moment the participant starts taking off the device until they have completely removed it.

  Up to 11 weeks

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

  Four therapy activity tasks will be attempted every session by the participant. The therapist will record the level of assistance required to complete each task during the session, using a 6-item scale, from Total assistance to Independence, with Independence being the best outcome possible. The tasks are the following: sit-to-stand, walk 10 meters, turn 180 degrees, and stand-to-sit.

  Up to 11 weeks

• Time spent upright and time spent walking

  In each training session, the time spent upright (in minutes) and the time spent walking (in minutes) with the device will be automatically measured and registered by the device.

  Up to 11 weeks

• Number of steps walked

  In each session, the number of steps taken (step count) with the device will be automatically measured and registered by the device.

  Up to 11 weeks

• Distance walked

  In each session, the distance walked (in meters) with the device will be automatically measured and registered by the device.

  Up to 11 weeks

Secondary Outcomes (13)

• Timed 25-Feet Walk test (T25FW)

  Up to 11 weeks

• Ambulation Index (AI)

  Up to 11 weeks

• 6-Minute Walk Test (6MWT)

  Up to 11 weeks

• Timed Up-and-Go test (TUG)

  Up to 11 weeks

• Trunk Impairment Scale (TIS)

  Up to 11 weeks

Study Arms (1)

Gait training with exoskeleton

EXPERIMENTAL

Participants with MS will undergo a training program with the ABLE Exoskeleton device: a total of 10 sessions, distributed 1-2 sessions/week for up to 11 weeks.

Device: ABLE Exoskeleton

Interventions

ABLE Exoskeleton DEVICE

Participants with MS will undergo a training program with the ABLE Exoskeleton device: a total of 10 sessions, distributed 1-2 sessions/week for up to 11 weeks.

Gait training with exoskeleton

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ABLE Human Motion S.L.: lead
• Fundación Esclerosis Múltiple Madrid (FEMM): collaborator

Study Sites (1)

Fundación Esclerosis Múltiple Madrid (FEMM)

Madrid, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 15, 2024
• Study Start: April 8, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-05

Locations

ES (1)