## Protocol Section
### Identification Module
**NCT ID:** NCT06429085

**Acronym:** RAPPER IV

**Brief Title:** Rex Robot Assisted Rehabilitation to Enhance Balance and Mobility for People With Multiple Sclerosis, Clinical and Biomarker Study - RAPPER IV

**Official Title:** Rex Robot Assisted Rehabilitation to Enhance Balance and Mobility for People With Multiple Sclerosis, Clinical and Biomarker Study - RAPPER IV

#### Organization Study ID Info
**ID:** Protocol Version 2.0
#### Organization
**Class:** OTHER_GOV
**Full Name:** East Kent Hospitals University NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2020-03-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-03-31

**Type:** ACTUAL

#### Start Date
**Date:** 2018-12-18

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Rex Bionics

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** East Kent Hospitals University NHS Foundation Trust

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** The key research questions:

* Is it feasible for a person with balance and mobility impairment caused by MS to use a robotic walking device to exercise in standing and walking with supervision safely?
* What are the key outcome measures most sensitive to measurable change in this study population sample, which may reflect potential improvement during the trial period? (Clinical outcome scales and self-reported questionnaires)
* Is this robotic assisted balance and mobility training program feasible, safe and effective?
* Does the completion of this balance and mobility exercise treatment intervention result in measurable improvements in balance, mobility, spasticity, lower limb joint range of movement and achievable individual patient goals?

To answer these questions, we invited 20 people diagnosed with MS (as defined by "McDonald" criteria, Polman et al, 2011) to undertake a 5-week balance exercise intervention program supported by the use of the Rex robotic walking device, designed to strengthen their postural body and leg muscles and improve their balance.

Participants were monitored and progressed on an individual basis throughout the treatment program as appropriate and a range of standardised assessments, questionnaires and relevant clinical outcome scales were used to capture and measure change related to this trial.

Prospective, open label, single arm, non-randomized, non-comparative feasibility study of Rex robot assisted training to improve balance, mobility and cardiovascular fitness for people living with MS.

A purposive sample of 20 adults, who have a primary diagnosis of MS, aged between 18 and 80 years old, with an Expanded Disability Status Scale (EDSS) as defined by Kurtzke (1983), with scores between 4 and 6.5 were recruited into this study.

### Conditions Module

**Conditions:**

- Multiple Sclerosis

**Keywords:**

- Balance

- Core stability

- Mobility

- Powered exoskeleton

- Neuro-rehabilitation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Prospective, open label, single arm, non-randomized, non-comparative feasibility study of Rex robot assisted training to improve balance and mobility for people living with MS.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Use of powered Rex robotic exoskeleton to enable the practice of core stability balance exercises

**Intervention Names:**

- Device: Rex robotic assisted balance exercises

**Label:** People diagnosed with Multiple Sclerosis

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- People diagnosed with Multiple Sclerosis

**Description:** Individual is supported by a Rex robotic exoskeleton which enables assisted and supervised practise of balance exercises. This intervention took place as a supported and supervised series of 5 sessions over 5 weeks as an Out-patient.

**Name:** Rex robotic assisted balance exercises

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Timed transfer into the Rex device with appropriate level of assistance

**Measure:** Timed transfer into the Rex device

**Time Frame:** Time point 1 - Week 1

**Description:** Completion of sit to stand and stand to sit within the Rex device with hands on assistance from trial therapist

**Measure:** Completion of sit to stand and stand to sit within the Rex device

**Time Frame:** Time point 1 - Week 1

**Description:** Completion of 1 Rex robotic assisted balance rehabilitation exercise session with hands on assistance from trial therapist

**Measure:** Completion of 1 Rex robotic assisted balance rehabilitation exercise session

**Time Frame:** Time point 1 - Week 1

**Description:** Number of individuals screened and those eligible who entered the trial and those who completed the trial

**Measure:** Screening loss analysis

**Time Frame:** End of recruitment period - Week 30

#### Secondary Outcomes

**Description:** Timed up and Go

**Measure:** Timed up and Go

**Time Frame:** Time point 1 - Week 1

**Description:** Berg Balance Scale

**Measure:** Berg Balance Scale

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

**Description:** Visual Analog Scale (Pain)

**Measure:** Visual Analog Scale (Pain)

**Time Frame:** Measured at 2 time points: Weeks 1 and 6

**Description:** Balance and falls risk

**Measure:** Modified Falls Efficacy Scale

**Time Frame:** Measured at 2 time points: Weeks 1 and 6

**Description:** Balance and confidence in balance

**Measure:** Activities-specific Balance Confidence scale

**Time Frame:** Measured at 2 time points: Weeks 1 and 6

**Description:** Perception of impact of spasticity on life

**Measure:** Spasticity Impact Scale

**Time Frame:** Measured at 2 time points: Weeks 1 and 6

**Description:** Perceived Health Related Quality of Life

**Measure:** EQ-5D-5L

**Time Frame:** Measured at 2 time points: Weeks 1 and 6

**Description:** Perceived impact of MS on life

**Measure:** MSIS-29

**Time Frame:** Measured at 2 time points: Weeks 1 and 6

**Description:** Joint range of movement

**Measure:** Joint range of movement

**Time Frame:** Measured at 2 time points: Weeks 1 and 6

**Description:** Goal Attainment Scale

**Measure:** Goal Attainment Scale

**Time Frame:** Set at Week 1 and measured and reviewed at Week 25

**Description:** Modified Ashworth Scale for muscle spasticity

**Measure:** Modified Ashworth Scale

**Time Frame:** Measured at 2 time points: Weeks 1 and 6

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 79 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Canterbury

**Country:** United Kingdom

**Facility:** East Kent Hospitals University NHS Trust

**State:** Kent

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Zajicek J, Fox P, Sanders H, Wright D, Vickery J, Nunn A, Thompson A; UK MS Research Group. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. Lancet. 2003 Nov 8;362(9395):1517-26. doi: 10.1016/S0140-6736(03)14738-1.

**PMID:** 14615106

**Citation:** Straudi S, Fanciullacci C, Martinuzzi C, Pavarelli C, Rossi B, Chisari C, Basaglia N. The effects of robot-assisted gait training in progressive multiple sclerosis: A randomized controlled trial. Mult Scler. 2016 Mar;22(3):373-84. doi: 10.1177/1352458515620933. Epub 2015 Dec 10.

**PMID:** 26658817

**Citation:** Bethoux F, Bennett S. Introduction: enhancing mobility in multiple sclerosis. Int J MS Care. 2011 Spring;13(1):1-3. doi: 10.7224/1537-2073-13.1.1. No abstract available.

**PMID:** 24453699

**Citation:** Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.

**PMID:** 23669008

**Citation:** Donze C. Update on rehabilitation in multiple sclerosis. Presse Med. 2015 Apr;44(4 Pt 2):e169-76. doi: 10.1016/j.lpm.2014.10.019. Epub 2015 Mar 4.

**PMID:** 25746432

**Citation:** Wiles CM, Newcombe RG, Fuller KJ, Shaw S, Furnival-Doran J, Pickersgill TP, Morgan A. Controlled randomised crossover trial of the effects of physiotherapy on mobility in chronic multiple sclerosis. J Neurol Neurosurg Psychiatry. 2001 Feb;70(2):174-9. doi: 10.1136/jnnp.70.2.174.

**PMID:** 11160464

**Citation:** Cattaneo D, Jonsdottir J, Zocchi M, Regola A. Effects of balance exercises on people with multiple sclerosis: a pilot study. Clin Rehabil. 2007 Sep;21(9):771-81. doi: 10.1177/0269215507077602.

**PMID:** 17875557

**Citation:** Birch N, Graham J, Priestley T, Heywood C, Sakel M, Gall A, Nunn A, Signal N. Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid. J Neuroeng Rehabil. 2017 Jun 19;14(1):60. doi: 10.1186/s12984-017-0274-6.

**PMID:** 28629390

**Citation:** Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

**PMID:** 6685237

**Citation:** Sakel M, Saunders K, Hodgson P, Stephensen D, Phadke CP, Bassett PA, Wilkinson D. Feasibility and Safety of a Powered Exoskeleton for Balance Training for People Living with Multiple Sclerosis: A Single-Group Preliminary Study (Rapper III). J Rehabil Med. 2022 Dec 9;54:jrm00357. doi: 10.2340/jrm.v54.4544.

**PMID:** 36484722

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020278

- Term: Demyelinating Autoimmune Diseases, CNS

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003711

- Term: Demyelinating Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M12060

- Name: Multiple Sclerosis

- Relevance: HIGH

- As Found: Multiple Sclerosis

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22098

- Name: Demyelinating Autoimmune Diseases, CNS

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M6909

- Name: Demyelinating Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009103

- Term: Multiple Sclerosis

- ID: D000012598

- Term: Sclerosis

### Misc Info Module

- Version Holder: 2024-05-31
