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

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• Spinal Cord Injuries 1,948

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 18 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Lead sponsor

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  House rehabilitation

  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

• Experimental
  Central rehabilitation

  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

• DeviceRehabilitation

  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.

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.

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

Secondary outcomes

1. Incremental cost utility ratio (ICUR) associated to the treatment

   Incremental cost utility ratio (ICUR) associated to the treatment: it provides healthcare decision- makers and providers with a straightforward information, that is, how much a "unit of utility improvement" would cost them and/or the society. Assuming a timeframe of analysis and two alternative technologies or treatments A and B, ICUR is the ratio between the difference in costs and the difference in utility of A and B

   Time frame: This outcome will be assessed immediately after the intervention

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

   Incidence of major adverse events related to the exoskeleton use: falls, bone fractures, skin lesions, pressure lesions, cardiovascular events

   Time frame: This outcome will be assessed immediately after the intervention

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

   Strides and steps performed with the exoskeleton are counted automatically by the exoskeleton system. This parameters can be monitored by connecting to the exoskeleton system via a proprietary software.

   Time frame: This outcome will be assessed immediately after the intervention.

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

   The SUS evaluates the usability of the assistive technology. It consists in 10 items with five response options for respondents, from Strongly agree to Strongly disagree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. The higher the score, the higher the usability.

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

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

   The QUEST evaluates a person's satisfaction with the assistive technology. It yields three scores: (i) Device, (ii) Services, and (iii) a total QUEST score. (i) consists of 10 items with five response options for respondents, from Strongly agree to Strongly disagree; the score is calculated by averaging the valid item responses; score range: 1-5. (ii) consists of 4 items with five response options for respondents, from Strongly agree to Strongly disagreeare; the score is calculated by averaging the valid item responses; score range: 1-5. (iii) is calculated by averaging the score of (i) and (ii). The QUEST presents a final section where the participants must indicate the three most important features of the technology.

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

6. Change in mental status assessed by the Patient Health Questionnaire-9 (PHQ-9) questionnaire

   The PHQ-9 aims at identifying probable major depressive disorder among adult primary care patients. It consists in 9 items with four response options for respondents, from Never to Almost always. The final score is calculated by summing the valid item responses. Score range: 0 -27. The higher the score, the higher the level of depression.

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

7. Change in mental status assessed by the General Anxiety Disorder Scale (GAD-7) questionnaire

   The GAD-7 assesses participant's anxiety. It consists of 7 items with four response options for respondents, from Never to Almost always. The final score is calculated by summing the valid item responses. Score range: 0 -21. The higher the score, the higher the level of anxiety.

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

8. 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

   The VO2 consumption is measured with a metabolic system throughout an exercise protocol with an arm-ergometer. According to previous study protocols, the VO2 consumption in the last 30 seconds of the arm-ergometer test are used to estimate the peak of VO2 consumption. After, this value is converted in METs.

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

9. Change in muscular spasticity assessed by the Modified Ashworth Scale (MAS)

   The MAS assesses the resistance to passive range of motion about a single joint with a 6-point rating scale. It's performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension ( the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. The higher the score, the higher the muscular spasticity. The scores can assume the following values: 0 - No increase in tone;1 - slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension; 1+ - slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout the range of motion; 2 -more marked increase in tone but more marked increased in muscle tone through most limb easily flexed; 3 - considerable increase in tone, passive movement difficult; 4 - limb rigid in flexion or extension.

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

10. Change in integrity of the rotator cuff muscles assessed by Jobe's test and Speed's test

    The Jobe's test aids in diagnosing rotator cuff tears or subacromial impingement. The examiner passively elevates the patient's shoulder to 90 degrees of abduction with internal rotation. The examiner then applies a downward pressure against the arm. A positive test is the provocation of pain or abnormal weakness. The Speed's test is used to test for superior labral tears or bicipital tendonitis. To perform the Speed's Test, the examiner places the patient's arm in shoulder flexion, external rotation, full elbow extension, and forearm supination; manual resistance is then applied by the examiner in a downward direction. The test is considered to be positive if pain in the bicipital tendon or bicipital groove is reproduced In both test, the exerted force will be also measured using a dynamometer.

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

11. Change in self-care and independence assessed by the Spinal Cord Independence Measure (SCIM) questionnaire

    The SCIM assesses of the ability of SCI patients to perform basic activities of daily living. It assesses three subscales: (i) self-care, (ii) respiration and sphincter management, and (iii) mobility. (i) consists in 6 items with four or five response options for respondents. Score range: 0-20. (ii) consists in 4 items with three to six response options for respondents. Score range: 0-40. (iii) consists in 8 items with three to nine response options for respondents. Score range: 0-40. Each subscale score is evaluated separately by summing the valid item responses. The higher the score, the higher the level of independence.

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

12. Change in pain assessed by Visual Analogue Scale (VAS)

    The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression. It consists in a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain in this case) orientated from the left (worst) to the right (best).

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

13. Change in sphincter's functionality assessed by a 5-Likert scale

    The 5-Likert scale consists of a single item which investigates the patients self-perceived sphincter's functionality, ranging from 1 (worst case) to 5 (best case)

    Time frame: This outcome will be assessed at the beginning of the trial and at each follow-up (every 6 months) until trial completion

14. Change in velocity during ambulation assessed by the 6 Minutes Walking Test (6 MWT)

    The 6 MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

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

15. Change in velocity during ambulation assessed by the 10 Meters Walking Test (10 MWT)

    The 10 MWT is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.

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

Individual participant data

Plan to share: No — Pseudonymized data could be shared upon request only