Personal Exoskeleton or Manual Wheelchair: a Comparison of Performance and Satisfaction in Activities of Daily Living Among People With Spinal Cord Injuries, Using the SCED Methodology. (KER-EXHOME)

September 14, 2026 updated by: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Spinal cord injuries resulting in paraplegia affect patients' mobility and, consequently, their ability to participate in activities of daily living. In France, according to available sources, the number of people with a symptomatic spinal cord injury is estimated to be between 97,000 and 132,000, with an average age of 55. The incidence is estimated at 1,300 new cases per year.

Following initial treatment, patients' aim is to resume their daily activities. Engaging in these activities is associated with a better quality of life and is recognised as having a positive effect on health. Limitations in their ability to move around directly affect their participation in activities of daily living and, consequently, their quality of life.

To this end, mobility can be supported by a manual wheelchair (MW) or an electric wheelchair (EW); however, these aids do not enable patients to regain the ability to stand, which remains one of the main goals for people with spinal cord injuries.

Robotic exoskeletons can assist with standing and locomotion. To date, robotic exoskeletons have been used in rehabilitation centres. During the rehabilitation phase, these devices have proven to be usable and safe for a wide range of patients with spinal cord injuries. Motorised exoskeletons thus enable patients to perform tasks such as walking, standing upright, rotating, and carrying out dynamic balance exercises.

In the longer term, personal exoskeletons, used at home, could facilitate the performance of productive, domestic, social or recreational activities, such as those carried out on a daily basis by every individual.

Personal powered exoskeletons (PPEs) also appear to generate physiological and psychosocial benefits. Studies describe potential improvements in cardiovascular health, bladder and sphincter function, and a reduced risk of osteoporosis. After a few weeks of training with a motorised exoskeleton, patients report improvements in social functioning, mental health and sub-domains of general health perception on the SF36 Walk Wheel.

It should be noted that the ability to interact socially whilst standing is an important aspect of quality of life for patients with spinal cord injuries. Patients describe the pleasure of eye contact, of being able to walk with assistance, and an improvement in mood. The PPE would complement the wheelchair by enabling ambulation and participation in activities whilst standing.

Preserving upper limb function is a prerequisite for the widespread use of walking exoskeletons in everyday life. A self-supporting PPE, such as the EVE® device, which does not require the use of crutches, aims to enable users to stand up and walk whilst retaining the use of their upper limbs. This active balance control is a crucial function for achieving many functional skills in a domestic environment. One of the technological advantages of the self-balancing exoskeleton lies in the use of dynamics to eliminate the need for crutches, whilst ensuring walking safety.

The next step towards the development of personal exoskeletons for people with spinal cord injuries is to investigate the performance of activities of daily living whilst wearing an exoskeleton. To our knowledge, no such study has been carried out, and our work addresses a gap in the scientific literature by analysing the impact of using a self-propelled PPE on satisfaction and performance when carrying out activities of daily living.

The investigators hypothesise that the personal exoskeleton leads to greater satisfaction when carrying out the four tasks of daily living, compared with that achieved using a manual wheelchair.

In this context, the KER-EXHOME clinical trial, proposed by Dr Stéphanie LEPLAIDEUR (coordinator of this study), and led by the Kerpape Centre (sponsor), aims to compare, in participants with paraplegia, satisfaction and performance when carrying out activities of daily living and physical activities, using the EVE® device compared with a manual wheelchair.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The KER-EXHOME study is a single-case experimental design (SCED) with multiple baseline conditions. This methodology enables the analysis of data from a limited number of subjects and is based on three principles: each subject serves as their own control; frequent, repeated measurement of each subject's performance throughout the study phase; and the sequential, randomised introduction of the intervention during the study, which ensures the necessary statistical power.

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Ploemeur, France, 56270
        • Centre de Kerpape
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stéphanie Leplaideur, Physician PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical presentation of paraplegia at a level between T5 and L5 inclusive, AIS A to C inclusive
  • Secondary to a spinal cord injury (traumatic or non-traumatic) occurring more than 6 months ago, clinically and functionally stable
  • Using a manual wheelchair for indoor and outdoor mobility
  • Able to tolerate 45 minutes of standing per day
  • Anthropometric compatibility with the device (weight, height, lower limb measurements, joint ranges of motion);
  • Whether or not they have previous experience of using a PPE;
  • Participants who have signed the written consent form to take part in the study following full and informed consent
  • Participants covered by a social security scheme (beneficiary or eligible dependant) other than the AME.

Exclusion Criteria:

  • Osteoporosis with a T-score < -2.5 at the femoral neck, as shown by a bone densitometry scan carried out within the last 12 months.
  • History of osteoporotic fracture(s)
  • Condition or treatment causing secondary osteoporosis (known thyroid disorder, known hypogonadism, known chronic gastrointestinal disease (ulcerative colitis and Crohn's disease), corticosteroid therapy, use of bisphosphonates for more than three months, early menopause (before the age of 45), abnormal calcium metabolism test results)
  • Progressive intercurrent conditions: pressure ulcers, infection, venous thrombosis
  • Cardiovascular or pulmonary conditions contraindicating exercise (e.g. heart failure or coronary artery disease within the last 6 months)
  • Untreated or uncontrolled hypertension (SBP > 140 mmHg; DBP > 90 mmHg);
  • Unresolved orthostatic hypotension (SBP < 90 mmHg; DBP < 60 mmHg) or deemed contraindicated by the investigator;
  • Unconsolidated or unstable bone lesions of the spine, limbs or pelvis
  • Known syringomyelia, as determined by medical assessment
  • Progressive osteoma, as determined by medical assessment
  • Severe spasticity of the adductor muscles, hamstrings, quadriceps and triceps surae (greater than 3 on the modified Ashworth scale)
  • Decompensated psychiatric or cognitive disorders that may interfere with the proper use of the device
  • Stoma
  • Wearing of an active implantable device An uncorrectable leg-length discrepancy of more than 2 cm when using additional corrective aids
  • Uncontrolled autonomic dysreflexia
  • Skin lesions at points of contact with the PPE (e.g. bruising, skin abrasions, etc.)
  • Need to use a respiratory support device whilst using Eve
  • Inability to operate the device effectively using a manual control interface, due to a functional and/or cognitive impairment, based on the ability to move the joystick in all directions, press and identify the buttons on the manual control interface.
  • Incorrect positioning of the participant in the device (excessive pressure on the support point).
  • Participant deprived of liberty (by court order or administrative decision)
  • Participant of legal age subject to a legal protection order or unable to give informed consent
  • Participation in another ongoing clinical trial
  • Pregnant or breastfeeding women, or women of childbearing age not using contraception
  • Lack of proficiency in spoken and written French

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carrying out tasks using the EVE exoskeleton and a manual wheelchair.

Training Phase, Week 1

The training phase for operating the EVE® exoskeleton covers the following functions (designed to ensure that the participant is trained in the use of the EVE® exoskeleton):

  • Standing up;
  • Testing in free mode;
  • Walking;
  • Turning round;
  • Half-squat;
  • Using precision mode;
  • Sitting down;
  • Carrying out emergency extraction training;
  • Archery training, if the participant has no prior experience. Participants will undergo training over 5 sessions, each lasting at least 60 minutes, spread over one week. A minimum of 5 hours' training is required to ensure safety.

Intervention phase, weeks 2 to 4 During this phase, participants will have a 3½-hour session every day (Monday to Friday). During each session, tasks will need to be carried out using the EVE® exoskeleton and the manual wheelchair.
Device: Carrying out tasks using the EVE exoskeleton and a manual wheelchair.
Each day (Monday to Friday), participants will have a 3½-hour session. During each session, tasks will need to be carried out using the EVE® exoskeleton and the manual wheelchair. The tasks have been grouped in pairs so that two tasks are carried out in succession. These task groups have been assigned a number, as follows: 1- Archery and retrieving a parcel 2- Making coffee and brushing teeth During a session, the participant will carry out one task group using both devices: the EVE® exoskeleton and the manual wheelchair. These devices have been assigned a letter, as follows: A- EVE® exoskeleton B- Manual wheelchair A random allocation will be used to determine the order of the parameters (B-wheelchair or A-EVE® exoskeleton), the time of day (morning or afternoon), and the task group to be performed in each session for each participant (1 or 2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare satisfaction and performance when carrying out four activities of daily living using the EVE® exoskeleton, versus those carried out using a manual wheelchair, using the Canadian Occupational Performance Measure (COPM)
Time Frame: Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25

The Canadian Occupational Performance Measure (COPM) will be used to compare perceived satisfaction and performance when carrying out identified activities of daily living using either the EVE® exoskeleton or a manual wheelchair. Using the COPM, satisfaction and performance are assessed on a scale of 1 to 10 (1 = very poor performance and satisfaction, 10 = full performance and satisfaction). MCRO scores show a significant improvement between the start and end of treatment; in the SCI validation study, the average improvement reported is approximately 4.25 points (Performance) and 2.96 points (Satisfaction) between two measurement points.

The MCRO will be carried out at the end of each session using one of the devices (wheelchair or exoskeleton). Two assessments must be carried out per half-day.
Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare user-assessed performance with clinician-assessed performance, using the Performance Quality Rating Scale (PQRS)
Time Frame: Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25

Measurement of task performance as reported by the clinician (occupational therapist and physiotherapist). Clinicians assess overall performance on a scale of 1 to 10 (1 being a failure and 10 being optimal performance) after each session.

The PQRS scale will be completed immediately after each task is performed for each of the two devices (wheelchair and PPE). Thus, four scores must be recorded per half-day.
Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25
Time taken to complete each task (in seconds).
Time Frame: Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25

The time will be recorded upon completion of each task, whether carried out in a wheelchair or using the PPE.

Thus, four times will need to be recorded per half-day.
Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25
To evaluate the user's perception of the ease of use of the EVE® exoskeleton, using the System Usability Scale (SUS)
Time Frame: Intervention phase (Week 2 to 4) : Day 12, Day 19, Day 26

The System Usability Scale (SUS) is a standardised questionnaire for measuring the usability of interactive systems, comprising ten items formulated as affirmative statements. For each statement, the user is asked to indicate their agreement or disagreement using a 5-point Likert scale (1 = Strongly disagree; 5 = Strongly agree). If the user is unsure how to respond to an item, they are asked to answer it anyway by ticking the centre of the scale (score 3).

Its aim is to measure users' perceptions of a product or service based on their experiences.

The SUS will be assessed at the end of each week. Three SUS ratings will be carried out during the intervention phase.
Intervention phase (Week 2 to 4) : Day 12, Day 19, Day 26
To assess the psychosocial impact of the EVE® exoskeleton using the French-Canadian version of the F-PIADS scale, which measures the psychosocial impact of an assistive device.
Time Frame: End of the intervention phase (week 4) : Day 26

This is a 26-item questionnaire that measures the impact on quality of life (psychosocial effects) of using a functional aid from the perspective of the person with a disability, by assessing three concepts: Competence (12 items), Adaptability (6 items) and Self-esteem (8 items).

When completing the questionnaire, the respondent rates each item on a 7-point Likert scale ranging from -3 ('maximum negative impact') to +3 ('maximum positive impact'). A score of 0 indicates 'no impact'. The final score is the average obtained by adding up the scores for all items and dividing the total by 26.

The F-PIADS will be carried out at the end of the intervention phase. Two assessments will be conducted, one for each device (wheelchair and PPE).
End of the intervention phase (week 4) : Day 26
Assess the perceived exertion involved in performing four everyday tasks using the Rate of Perceived Exertion (RPE) scale.
Time Frame: Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25

The RPE scale is a valid method for quantifying physical exertion across a wide variety of exercise types.

It comprises the following categories: a scale from 0 to 10: 0 None, 1 Very easy, 2 Quite easy, 3 Moderate, 4 Quite difficult, 5 Difficult, 7 Very difficult, 10 Very, very difficult. This scale will be used to assess the perception of exertion after completing each task, whether performed in a wheelchair or using the EVE® exoskeleton.
Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25
Assessing the reliability of the EVE® exoskeleton.
Time Frame: Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25
The performance of the EVE® exoskeleton will be assessed by counting the number of faults that occur during use. A fault is recorded whenever there is an interruption in use that requires the user to return to a seated position, as no other action is then possible.
Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape

Collaborators

Wandercraft
Groupement des Hôpitaux de l'Institut Catholique de Lille

Investigators

  • Principal Investigator: Stéphanie Leplaideur, Physician PhD, Centre de Kerpape

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

August 26, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A02452-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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