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

NCT05811884 | Suspended DMC

• 1 other identifier: SSC DCAPR Prospettico
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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. 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. 2.How much do the two treatments differ in terms of cost-utility ratio?
3. 3.Recruitment, based on eligibility criteria;
4. 4.Observation of the "stability" over time (2 months) of specific clinical parameters;
5. 5.Training in the use of the powered exoskeleton (1 month);
6. 6.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.
7. 7.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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Change in quality of life (QoL)

  Short Form-36 questionnaire (SF-36): Generic health status measure. It applies to all health conditions and contains 36 items, divided in 8 domains. The higher the score, the higher the QoL.

  This outcome will be assessed at the baseline and immediately after the intervention

Secondary Outcomes (15)

• Incremental cost utility ratio (ICUR) associated to the treatment

  This outcome will be assessed immediately after the intervention

• Incidence of Treatment-Emergent Adverse Events assessed by self-report and extracted from the medical records

  This outcome will be assessed immediately after the intervention

• Active use assessed by the number of strides and steps performed with the exoskeleton.

  This outcome will be assessed immediately after the intervention.

• Change in usability assessed by the System Usability Scale (SUS) questionnaire

  This outcome will be assessed at the baseline and at the months 6, 12, 18, 24

• Change in satisfaction assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) questionnaire

  This outcome will be assessed at the baseline and at the months 6, 12, 18, 24

Study Arms (2)

House rehabilitation

EXPERIMENTAL

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.

Device: Rehabilitation

Central rehabilitation

EXPERIMENTAL

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.

Device: Rehabilitation

Interventions

Rehabilitation DEVICE

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. 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.

Central rehabilitation; House rehabilitation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro: lead

Study Sites (1)

Centro Protesi Inail

Budrio, Bologna, 40054, Italy

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 13, 2023
• Study Start (Estimated): January 1, 2030
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): February 1, 2033
• Last Updated: March 27, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)