Clinical trial NCT05276453: Effect of Pressotherapy on Health Outcomes in Patients With Chronic Stroke
Official title: Effect of Dynamic Pressotherapy on Vascular, Functional and Quality of Life Outcomes in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Winchester
Sponsor class: OTHER
Collaborators: name: Hobbs Rehabilitation
First posted: 2022-03-11
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised to either an experimental (Lower limb compression suit) or active comparator group
Primary purpose: BASIC_SCIENCE

Brief summary: This study intends to recruit stroke patients to either wearing a lower-limb compression (GMove) suit, daily, for 12 weeks, or to a normal therapy control group. Vascular, functional and quality of life outcomes will be collected before and after randomisation.

Detailed description: Background/Rationale Stroke is a leading cause of adult disability in the UK, with over 1.2 million people living with the debilitating effects. It is estimated that approximately three quarters of individuals with stroke have fallen in the six months following discharge from hospital, and more recent research suggests that falls rates remained as high as 50% amongst those living in the community following stroke. With falls costing the National Health Service approximately £1.7 billion per year, neurorehabilitation is vital in order to improve balance and prevent falls in the stroke population. Evidence suggests that a key component of improving balance and mobility is through task-specific training that incorporates actual walking practice and lower limb muscle strengthening.

Dynamic pressotherapy is defined as a movement of compression/decompression, associated with a physical effort at variable intensity, in order to stimulate venous return. The GMOVE Suit (CE Marked; GMOVE-SUIT - GMOVE SUIT; Appendix B) is a lower limb active pressotherapy device that may increase muscle activity and muscle tone, and support mobility renewal by stimulating the activation of lower-limb muscle pumping and muscle restraint during physical activity (via periods of compression/decompression of the device). In clinical populations, case studies with people with Ehlers-Danlos Syndrome, Parkinson's Disease, Spinal Cord Injury, Stroke and Multiple Sclerosis, have demonstrated improvements in proprioception, functional outcomes, including the 'Get Up and Go' test, knee stability and control, and walking with greater hip and knee extension following regular usage of the GMOVE Suit.

Due to the portability of the device, there is substantial potential to use the GMOVE Suit in a home-based rehabilitation environment, whereby participants would have the potential to engage in daily physical activity whilst wearing the device. As the GMOVE Suit may encourage an increase in physical activity, there could be substantial benefit in stroke patients engaging in a structured (as determined by a neuro-physiotherapist), home-based rehabilitation programme which may improve vascular health (e.g., blood pressure), functional outcomes (walking speed, walking endurance), balance and general quality of life.

Purpose The purpose of this research is to undertake a pilot randomised controlled study which will examine the effect of a home-based dynamic pressotherapy rehabilitation intervention, using the GMOVE Suit, on functional, vascular and quality of life parameters in individuals with chronic stroke.

Objectives

The objectives of this study are to:

1. Assess feasibility and patient adherence to using dynamic pressotherapy during home-based rehabilitation
2. Assess the effect of using dynamic pressotherapy on clinical functional outcomes of stroke patients
3. Assess the effect of using dynamic pressotherapy on balance and mobility of stroke patients
4. Assess the effect of using the dynamic pressotherapy on vascular outcomes (blood pressure, arterial stiffness) of stroke patients
5. Assess the effect of using dynamic pressotherapy on quality of life of stroke patients

Methods Thirty-two stroke patients will be recruited and randomised to either a dynamic pressotherapy (GMOVE Suit) group (n=16) or a usual care control group (n = 16). The inclusion/exclusion criteria are detailed elsewhere.

Research Design The baseline and post-intervention (PI) assessments will be conducted at the University of Winchester and Hobbs Rehabilitation. The rehabilitation training intervention will take place in participants' home. All outcome measures are detailed elsewhere

Randomisation and training programme On completion of the physio-specific measures participants will be randomised to either a dynamic pressotherapy group or to a usual care control using a computer-generated randomisation sequence (www.randomizer.org). Those participants randomised to the pressotherapy group will be familiarised with the GMOVE Suit and will trained how to use it by the physiotherapists. The rehabilitation programme will include activities such as walking, stepping, squats etc. Thereafter, participants will use the GMOVE Suit at home for 8 weeks. Every week they will receive feedback from the physiotherapists with regards to the necessary settings to encourage physical progression. In weeks 1, 3, 5 and 7 this will be in the form of a face-to-face session with the physiotherapists. In weeks 2, 4 and 6, this will be in the form of a video/phone call to discuss progress. These sessions are anticipated to take between 15 and 30 minutes each.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical diagnosis of stroke (within 3 months and 7 years of diagnosis)
* Community patients that are medically stable
* Individuals who are able to stand and step (at least 10m) with (or without) an aid or assistance
* Cognitively aware of task demands

Exclusion Criteria:

* Unresolved deep vein thrombosis
* Unstable cardiovascular conditions
* Open wounds
* Active drug resistant infection
* Recent fractures of involved limb
* Peripheral arterial disease
* Severe osteoporosis
* Non weight bearing
* Diabetes

Primary outcomes:
measure: Central blood pressure
timeFrame: Baseline, up to 12 weeks after baseline.
measure: Peripheral blood pressure
timeFrame: Baseline, up to 12 weeks after baseline.
measure: Augmentation Index
timeFrame: Baseline, up to 12 weeks after baseline.
measure: Pulse Wave Velocity
timeFrame: Baseline, up to 12 weeks after baseline.
Secondary outcomes:
measure: Time-Up-And-Go
timeFrame: Baseline, up to 12 weeks after baseline.
measure: 10 m walk test
timeFrame: Baseline, up to 12 weeks after baseline.
measure: 6 minute walk test
timeFrame: Baseline, up to 12 weeks after baseline.
measure: Berg Balance
timeFrame: Baseline, up to 12 weeks after baseline.
measure: Balance Confidence Scale
timeFrame: Baseline, up to 12 weeks after baseline.
measure: Functional Ambulation Classification
timeFrame: Baseline. Each assessment will take 2 minutes
measure: Fugl-meyer assessment
timeFrame: Baseline, up to 12 weeks after baseline.
measure: Weight
timeFrame: Baseline, up to 12 weeks after baseline.
measure: Height
timeFrame: Baseline, up to 12 weeks after baseline.
measure: Body Mass Index (BMI)
timeFrame: Baseline, up to 12 weeks after baseline.
measure: Waist-to-Hip ratio
timeFrame: Baseline, up to 12 weeks after baseline.
measure: Sit to Stand
timeFrame: Baseline, up to 12 weeks after baseline.
Other outcomes:
measure: International Physical Activity Questionnaire Short-Form
timeFrame: Baseline, up to 12 weeks after baseline.
measure: General Health Questionnaire -Short-Form-12 (SF12)
timeFrame: Baseline, up to 12 weeks after baseline.
Locations:
city: Winchester
country: United Kingdom
facility: University of Winchester
state: Hampshire
Study officials:
affiliation: University of Winchester
name: Simon Jobson, PhD
role: STUDY_DIRECTOR
References: