Patient-centered Assessment of the Effects of Powered Exoskeleton Use in People With Spinal Cord Injury

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Status: Suspended

Conditions: Spinal Cord Injuries

Treatments: Device: Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05811884

SSC DCAPR Prospettico

Details and patient eligibility

About

The goal of this clinical trial is to assess the efficacy of the use of powered exoskeleton for ambulation on the quality of life in subjects with spinal cord injury. The main questions it aims to answer are:

1. How much does the use of powered exoskeleton improve the quality of life in subjects with spinal cord injury after a 24 months treatment period in a house context (treatment 1) or in a clinical setting (treatment 2)?
2. How much do the two treatments differ in terms of cost-utility ratio?

Participants will be included in a multi-step process consisting of:

1. Recruitment, based on eligibility criteria;
2. Observation of the "stability" over time (2 months) of specific clinical parameters;
3. Training in the use of the powered exoskeleton (1 month);
4. Random selection of the rehabilitation treatment (house rehabilitation or central rehabilitation); concerning the house rehabilitation, the subject will be provided the device for home use; concerning the central rehabilitation, the subject will be asked to use intensively the device 1-week every three months in a clinical facility.
5. Follow-up: every six months each subject will be asked to attend a single-day activities session consisting of walking activities with the exoskeleton, compilation of questionnaires, sub-maximal effort test with arm-ergometer, and physical examinations made by a physiatrist.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Assisted by Inail;
• Age between 18 and 65 years;
• Body weight lower than 113 Kg;
• Level of spinal lesion T4 and higher;
• Integrity of upper limbs (strength and range of motion assessed by a clinical operator);
• Abbreviated Injury Scale (AIS) score A or B;
• Number of months after lesion higher than 6;
• Anthropometry in conformity with the declarations of exoskeleton's manufacturers.

Exclusion criteria

• Use of the powered exoskeleton in the last 6 months (in this case a wash-out phase is required);
• Use of colostomy bag;
• The subject is pregnant/ nursing;
• Presence of cognitive impairments;
• Presence of severe neurologic lesions in addition to SCI (sclerosis, cerebral palsy or trauma,...);
• Severe comorbidities;
• Uncontrolled hypertension or orthostatic hypotension;
• Uncontrolled autonomic dysreflexia;
• Problems at the skeletal system: T-score of femoral neck lower than -3 (DEXA examination is required), bone mineral density of proximal tibia or distal femur lower than 0.6 g/cm2, presence of non-recovered fractures, ectopic ossification, unstable spine;
• Kinesiologic impairments of the lower limbs: Ashworth spasticity of hamstrings, quadriceps, gastrocnemius muscles (right/ left) lower than 4, uncontrolled clonic spasm, pathologic contractures: non conformity of the range of motion of ankle/ knee/ hip with the requisites for use of powered exoskeletons for ambulation, presence of pressure lesions, dysmetria: femurs higher than 1.5 cm/ tibias higher than 2 cm;
• Kinesiologic impairments of the upper limbs: limitations at the joints, weakness of shoulder/ elbow/ hand (manual evaluation by a clinician), no autonomy in transfers;
• Weak control of the trunk;
• Inability to stand for at least 30 minutes;
• Presence of joint prostheses in upper and lower limbs;
• Use of drugs that may affect cognition and coordination while using the exoskeleton.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

18 participants in 2 patient groups

House rehabilitation

Experimental group

Description:

The subjects will be provided of the powered exoskeleton for home use. No specific indications will be provided, but using the technology as much as possible. Every six months, the subjects will be asked to attend a single-day session by the clinical facility (follow-up session) consisting on the assessement of a series of qualitative and quantitative measurements.

Treatment:

Device: Rehabilitation

Central rehabilitation

Experimental group

Description:

The subjects will be asked to attend to periodic rehabilitation sessions by the clinical facility. The rehabilitation session will consist in an intense 1-week activities session every three months. Every six months, the subjects will be asked to attend a single-day session by the clinical facility (follow-up session) consisting on the assessement of a series of qualitative and quantitative measurements.

Treatment:

Device: Rehabilitation