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Feasibility of exoskeleton training for home use for patient with motor complete spinal cord injury.

Feasibility of exoskeleton training for home use for patient with motor complete spinal cord injury. - Feasibility of exoskeleton training for use at home.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42978
Enrollment
25
Registered
2016-06-16
Start date
2016-06-30
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paralysis Paraplegia

Interventions

None listed

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - SCI classification ASIA A or B, - Level of SCI between T1 and L1, - Age >= 18 years, - Good arm and hand function (ability to use crutches), - Can extend the legs almost complete (ROM knee 90/5/0, ROM hip 90/0/0) - Can independently make a transfer from a chair to a wheelchair (use of slide is not needed).

Exclusion criteria

Exclusion criteria: The main exclusion criteria are: - Severe spasticity (Modified Ashworth Scale> 3), - Taller than 1.90 and smaller than 1.60 meter, - Bodyweight of more than 100 kg, - Insufficient time to train - Other interfering conditions (CVA or insufficient mastery of the Dutch language).

Design outcomes

Primary

MeasureTime frame
The primary outcome parameters are: 1) The number of skills a patient is able to perform after a training period of eight weeks, 2) The percentage of participants who can use the exoskeleton at home (after a training period of eight weeks) and 3) The amount of use of the exoskeleton during the patients home use (derived from diaries and number of steps taken by the exoskeleton).

Secondary

MeasureTime frame
Secondary outcome parameters are: 4) Patient*s experience and 5) Health parameters; - Spasticity, - Bladder and bowel function - (Neuropathic) pain, - Range of motion (ankle and knee), - Quality of life and - Body experience.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)