Clinical trial NCT05811884: Patient-centered Assessment of the Effects of Powered Exoskeleton Use in People With Spinal Cord Injury
Official title: Patient-centered Assessment of the Effects of Powered Exoskeleton Use in People With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in quality of life (QoL)
timeFrame: This outcome will be assessed at the baseline and immediately after the intervention
Secondary outcomes:
measure: Incremental cost utility ratio (ICUR) associated to the treatment
timeFrame: This outcome will be assessed immediately after the intervention
measure: Incidence of Treatment-Emergent Adverse Events assessed by self-report and extracted from the medical records
timeFrame: This outcome will be assessed immediately after the intervention
measure: Active use assessed by the number of strides and steps performed with the exoskeleton.
timeFrame: This outcome will be assessed immediately after the intervention.
measure: Change in usability assessed by the System Usability Scale (SUS) questionnaire
timeFrame: This outcome will be assessed at the baseline and at the months 6, 12, 18, 24
measure: Change in satisfaction assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) questionnaire
timeFrame: This outcome will be assessed at the baseline and at the months 6, 12, 18, 24
measure: Change in mental status assessed by the Patient Health Questionnaire-9 (PHQ-9) questionnaire
timeFrame: This outcome will be assessed at the baseline and at the months 6, 12, 18, 24
measure: Change in mental status assessed by the General Anxiety Disorder Scale (GAD-7) questionnaire
timeFrame: This outcome will be assessed at the baseline and at the months 6, 12, 18, 24
measure: Change in fitness level assessed by the Metabolic Equivalents of Tasks (METs) associated to the consumption of oxygen (VO2) during a sub-maximal arm crank ergometer test
timeFrame: This outcome will be assessed at the baseline and at the months 6, 12, 18, 24
measure: Change in muscular spasticity assessed by the Modified Ashworth Scale (MAS)
timeFrame: This outcome will be assessed at the baseline and at the months 6, 12, 18, 24
measure: Change in integrity of the rotator cuff muscles assessed by Jobe's test and Speed's test
timeFrame: This outcome will be assessed at the baseline and at the months 6, 12, 18, 24
measure: Change in self-care and independence assessed by the Spinal Cord Independence Measure (SCIM) questionnaire
timeFrame: This outcome will be assessed at the baseline and at the months 6, 12, 18, 24
measure: Change in pain assessed by Visual Analogue Scale (VAS)
timeFrame: This outcome will be assessed at the baseline and at the months 6, 12, 18, 24
measure: Change in sphincter's functionality assessed by a 5-Likert scale
timeFrame: This outcome will be assessed at the beginning of the trial and at each follow-up (every 6 months) until trial completion
measure: Change in velocity during ambulation assessed by the 6 Minutes Walking Test (6 MWT)
timeFrame: This outcome will be assessed at the baseline and at the months 6, 12, 18, 24
measure: Change in velocity during ambulation assessed by the 10 Meters Walking Test (10 MWT)
timeFrame: This outcome will be assessed at the baseline and at the months 6, 12, 18, 24
Other outcomes:
Locations:
city: Budrio
country: Italy
facility: Centro Protesi Inail
state: Bologna
Study officials:
References: