SIR HELLEN (Spinal Cord InjuRy in the Hunter's Exoskeleton for Lower Limb Exercise and Neurorehabilitation)

Not Applicable

Completed

• Conditions: Spinal cord injury; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12618000626268
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-20
• Study Completion: 2020-03-11
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1.Diagnosis of traumatic or non-traumatic SCI at least 3 months prior to enrolment
2.Resident of the Hunter region
3.18 years of age or older
4.Discharged from inpatient rehabilitation programs
5.Severe mobility impairment and reliant on wheelchair, mobility aid, or the assistance of others for standing activities ( scores < /=5 on the mobility assessment of SCIM-III)

Exclusion Criteria

1.Weight between 40 kg and 100kg; height between 4’8” and 6'4 (as per the recommendations of the robotic manufacturer)
2.Pregnancy
3.Unstable or severe cardiac or respiratory compromise
4.Nonconsolidated fractures in lower limbs/pelvis/spine or diagnosed severe osteopenia ( t-score less than or equal to -2.5)
5.Significant cognitive impairment (Montreal Cognitive Assessment Score of less than 19)
6.Any medical condition which limits the ability to exercise in an upright position. This includes: pressure sores in contact with the exoskeleton, lower limb heterotrophic ossification, severe lower limb muscle contracture, spinal instability, acute deep vein thrombosis, recurrent attacks of autonomic dysreflexia requiring medical intervention, hip subluxation, a history of pathological fractures in the lower limbs in the last 2 years)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional ability as measured by the Spinal Cord Independence Measure (SCIM-III)[0, 12, 18, 24, 36 weeks after enrolment.<br><br>The primary timepoint is at week 24.]

Secondary Outcome Measures

Name	Time	Method
Mood - Hospital Anxiety and Depression Scale[0, 12, 18, 24, 36 weeks after enrolment.];Fatigue - Fatigue Assessment Scale[0, 12, 18, 24, 36 weeks after enrolment.];Spasticity - Tardieu scale[0, 12, 18, 24, 36 weeks after enrolment.];Endurance: Five times sit to stand test[0, 12, 18, 24, 36 weeks after enrolment.];Ambulation function (Lower extremity motor scale: LEMS)[0, 12, 18, 24, 36 weeks after enrolment.];Health related quality of life (Short form 8: SF8)[0, 12, 18, 24, 36 weeks after enrolment.];Strength of grip (Dynamometer assessment)[0, 12, 18, 24, 36 weeks after enrolment.];Body composition (Bioelectrical impedance analysis)[0, 12, 18, 24, 36 weeks after enrolment.];Perceptions of Robotic Therapy - questionnaire developed by this research team[0, 12, 18, 24, 36 weeks after enrolment.];Quads strength testing with dynamometer[0, 12, 18, 24, 36 weeks after enrolment.];Functional balance: Functional Reach Test[0, 12, 18, 24, 36 weeks after enrolment.]