Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429085
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-13
Brief Title:
Rex Robot Assisted Rehabilitation to Enhance Balance and Mobility for People With Multiple Sclerosis Clinical and Biomarker Study - RAPPER IV
Sponsor:
East Kent Hospitals University NHS Foundation Trust
Organization:
East Kent Hospitals University NHS Foundation Trust
Study Overview
Official Title:
Rex Robot Assisted Rehabilitation to Enhance Balance and Mobility for People With Multiple Sclerosis Clinical and Biomarker Study - RAPPER IV
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPPER IV
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
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 65 were recruited into this study
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 65 were recruited into this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None