CompletedPhase 1MS (type not specified)NCT06429085

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Rex robotic assisted balance exercises

What it measured

Main measures

  • Timed transfer into the Rex device

    Time point 1 - Week 1

  • Completion of sit to stand and stand to sit within the Rex device

    Time point 1 - Week 1

  • Completion of 1 Rex robotic assisted balance rehabilitation exercise session

    Time point 1 - Week 1

    Walking and mobilityPhysical function
  • Screening loss analysis

    End of recruitment period - Week 30

Other measures (11)

  • Timed up and Go

    Time point 1 - Week 1

    Walking and mobility
  • Berg Balance Scale

    Measured at 3 time points: Weeks 1, 6 and 10

    Walking and mobility
  • Visual Analog Scale (Pain)

    Measured at 2 time points: Weeks 1 and 6

    Pain
  • Modified Falls Efficacy Scale

    Measured at 2 time points: Weeks 1 and 6

    Walking and mobility
  • Activities-specific Balance Confidence scale

    Measured at 2 time points: Weeks 1 and 6

    Walking and mobility
  • Spasticity Impact Scale

    Measured at 2 time points: Weeks 1 and 6

    Spasticity
  • EQ-5D-5L

    Measured at 2 time points: Weeks 1 and 6

    Quality of life (reported by participants)
  • MSIS-29

    Measured at 2 time points: Weeks 1 and 6

    Quality of life (reported by participants)
  • Joint range of movement

    Measured at 2 time points: Weeks 1 and 6

  • Goal Attainment Scale

    Set at Week 1 and measured and reviewed at Week 25

Who could take part

MS (type not specified) · 18 to 79

Inclusion Criteria: * • Are aged greater than 18 years and less than 80 years * Have a confirmed diagnosis of MS by a Consultant Neurologist as per McDonald Criteria. * Have moderate mobility restriction as defined by an Extended Disability Status Scale (EDSS) score of between 4 to 6.5 * Ten participants to be recruited from EDSS 4 to 5.5 * Ten participants to be recruited from EDSS 5.5 to 6.5 * Within the anthropometric requirements of the REX device (See 'RAPPER III- MS 014 TF-04 v 3.0 REX Clinical Assessment Guide A4' for details of weight, height, size and range of motion requirements) * Offer written informed consent to take part in the study Exclusion Criteria: * a history of osteoporosis or osteoporosis related bone fractures. * skin integrity issues that could be adversely affected by the REX device * severe hypertonia (spasticity) as indicated by a score equal to or greater than 4 on the modified Ashworth scale for any muscle in their lower limbs. * a behavioural, cognitive or communication impairment which could interfere with the ability to participate in a rehabilitation program, as noted during screening (e.g., agitation, inability to follow two step commands) * are unable or unwilling to provide informed consent * are considered medically unsuitable for rehabilitation in the opinion of the screening medical specialist * a known allergy (skin contact) to materials used in Rex * are pregnant * taking part in any other medical research trial at the same time

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Multiple Sclerosis (MS) poses challenges to balance and mobility, impacting the daily lives of affected individuals. The RAPPER IV study is a clinical trial to evaluate a balance and mobility training intervention supported by a powered Rex robotic exoskeleton for people living with MS. Aims and objectives: This study aims to gain an insight into the potential health benefits of using a Rex robot to assist in a neuro-rehabilitation intervention program focused on improving balance and functional mobility with supervision from a specialist clinician. Objectives * to evaluate the feasibility of using the Rex robotic walking device for rehabilitation with people who have mobility restrictions due to Multiple Sclerosis (MS) * to assess and evaluate the clinical effectiveness of a 5-week robotic assisted exercise program focused on core stability exercises, balance and walking using patient related outcome measures * to gain an insight into the experiences of participants and their spouses of using the robotic walking device for rehabilitation and how this has impacted on their lives A single cohort group of 20 people who were living with MS who met trial eligibility criteria were recruited. A variety of clinical outcome measurements were taken pre, during and post trial and results were analysed by a statistician.

Papers

Loading reviews and guidelines…

History

    1. Started

      Dec 2018

    2. Main results due

      Mar 2020

    3. Finished

      Mar 2020

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