StrokeNCT05276453
Effect of Pressotherapy on Health Outcomes in Patients With Chronic Stroke
A study testing GMove Suit and Normal therapy in people with Stroke, run by University of Winchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- GMove Suit and Normal therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2022to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unresolved deep vein thrombosis
- Unstable cardiovascular conditions
- Open wounds
- Active drug resistant infection
- Recent fractures of involved limb
- Peripheral arterial disease
Show all 9Show fewer
- Severe osteoporosis
- Non weight bearing
- Diabetes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Winchester
Winchester, Hampshire, SO224NR
About this study
Official title: Effect of Dynamic Pressotherapy on Vascular, Functional and Quality of Life Outcomes in Patients With Chronic Stroke
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.
Read the 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:
- Assess feasibility and patient adherence to using dynamic pressotherapy during home-based rehabilitation
- Assess the effect of using dynamic pressotherapy on clinical functional outcomes of stroke patients
- Assess the effect of using dynamic pressotherapy on balance and mobility of stroke patients
- Assess the effect of using the dynamic pressotherapy on vascular outcomes (blood pressure, arterial stiffness) of stroke patients
- 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.
- Conditions
- Stroke
- Being tested
- GMove Suit, Normal therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMove SuitDevice
12 week, home-based programme whereby participants are encouraged to use the GMove suit daily, for at least 30 minutes a day. Recommended activities include walking, sit-to-stand and step-ups
Normal therapyBehavioural
Participants are randomized to a normal therapy (physiotherapy) only program. Participants are also advised to undertake 30 mins a day of physical activity and have active physical therapy (physiotherapy) sessions.
| Study group | Role | What they receive |
|---|---|---|
| GMove Suit | Experimental | Participants randomised to a group including normal therapy (physiotherapy) and the use of a lower-limb compression (GMove) Suit. All participants have previously completed normal NHS therapy. Receives: Device: GMove Suit |
| Normal therapy | Active comparator | Participants randomised to a group including normal therapy (physiotherapy) only. All participants have previously completed normal NHS therapy. Receives: Behavioral: Normal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central blood pressure
Pulse wave analysis (PWA) will investigate central blood pressure in mmHg following 15 minutes supine rest.
Measured: Baseline, up to 12 weeks after baseline.
Peripheral blood pressure
Pulse wave analysis (PWA) will investigate peripheral blood pressure in mmHg following 15 minutes supine rest.
Measured: Baseline, up to 12 weeks after baseline.
Augmentation Index
Pulse wave analysis (PWA) will investigate augmentation index as a percentage following 15 minutes supine rest.
Measured: Baseline, up to 12 weeks after baseline.
Pulse Wave Velocity
Pulse wave velocity (PWV) will be recorded between the carotid (right and left) and femoral artery, brachial artery and femoral artery, and femoral artery and the anterior tibial artery. All PWV measures will be recorded in metres per second
Measured: Baseline, up to 12 weeks after baseline.
Secondary outcomes (12)
Time-Up-And-Go
A stopwatch will be used to collect Timed-Up-and-Go data. From a seated position, participants will stand, walk to a cone 3 m away, walk around the cone, and walk back to the chair sit back down. Participants will complete two familiarisation trials prior to the actual test itself. A minimum of three trials will be performed.
Measured: Baseline, up to 12 weeks after baseline.
10 m walk test
Participants asked to walk as fast as they between two cones situation 10 m apart. The shorter the time means the better the performance. Three trials will be performed.
Measured: Baseline, up to 12 weeks after baseline.
6 minute walk test
A 6-minute shuttle walk test will determine total distance walked in metres
Measured: Baseline, up to 12 weeks after baseline.
Berg Balance
14-item test that assesses static and dynamic balance ability and fall risk in adult populations. Each activity is scored from 0-4, determined by the ability to perform the assessed activity with an overall maximum score of 56.
Measured: Baseline, up to 12 weeks after baseline.
Balance Confidence Scale
16-item self-report measure in which patients rate their balance confidence when performing various ambulatory activities. Rated from 0-100. This scale has excellent test-retest reliability (ICC = 0.85) within the Stroke population and adequate correlations with the Functional Gait Assessment (r = 0.53) in community dwelling elderly (Winsley \& Kumar, 2010).
Measured: Baseline, up to 12 weeks after baseline.
Functional Ambulation Classification
Assesses functional ambulation in participants undergoing physical therapy. Ranges from non-functional walking to independent walking outside with a scale for 0-5 respectively. The Functional Ambulation Classification has excellent validity with the 6 minute walking test in acute Stroke patients
Measured: Baseline. Each assessment will take 2 minutes
Fugl-meyer assessment
Upper and lower limb assessment of sensorimoter function
Measured: Baseline, up to 12 weeks after baseline.
Weight
Body weight will be measured in kilograms using weighing scales
Measured: Baseline, up to 12 weeks after baseline.
Height
Height will be measured in centimetres using a stadiometer
Measured: Baseline, up to 12 weeks after baseline.
Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m2.
Measured: Baseline, up to 12 weeks after baseline.
Waist-to-Hip ratio
Waist and Hip circumferences will be presented as a ratio
Measured: Baseline, up to 12 weeks after baseline.
Sit to Stand
Participant starts in a seated position and is asked to stand to upright before sitting back down. The participant is asked to do this 5 times as quickly as possible. The shorter the time the better the performance.
Measured: Baseline, up to 12 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Apr 2022
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised to either an experimental (Lower limb compression suit) or active comparator group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Winchester
- Sponsor type
- University, hospital or other
- Collaborators
- Hobbs Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Simon Jobson, PhD, Study director, University of Winchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276453
- Sponsor's protocol ID
- GMove_2022
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD outcome data that underpins publications will be shared with other researchers
Publications
Faulkner J, Paine E, Hudson N, Hannah S, Dennis-Jones A, Martinelli L, Hobbs H. Effect of using home-based dynamic intermittent pneumatic compression therapy during periods of physical activity on functional and vascular health outcomes in chronic stroke: A randomized controlled clinical trial. PLoS One. 2025 Feb 18;20(2):e0318942. doi: 10.1371/journal.pone.0318942. eCollection 2025.
PubMed 39964987
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dynamic Pressotherapy on Vascular, Functional and Quality of Life Outcomes in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT05276453
- Acronym / sponsor ID
- GMove_2022
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of WinchesterUniversity, hospital or other
- Collaborators
- Hobbs Rehabilitation
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess feasibility and patient adherence to using dynamic pressotherapy during home-based rehabilitation
- Assess the effect of using dynamic pressotherapy on clinical functional outcomes of stroke patients
- Assess the effect of using dynamic pressotherapy on balance and mobility of stroke patients
- Assess the effect of using the dynamic pressotherapy on vascular outcomes (blood pressure, arterial stiffness) of stroke patients
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomised to either an experimental (Lower limb compression suit) or active comparator group
| Arm | Type | Receives |
|---|---|---|
| GMove Suit | Experimental | Device: GMove SuitParticipants randomised to a group including normal therapy (physiotherapy) and the use of a lower-limb compression (GMove) Suit. All participants have previously completed normal NHS therapy. |
| Normal therapy | Active comparator | Behavioral: Normal therapyParticipants randomised to a group including normal therapy (physiotherapy) only. All participants have previously completed normal NHS therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Unresolved deep vein thrombosis
- Unstable cardiovascular conditions
- Open wounds
- Active drug resistant infection
- Recent fractures of involved limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMove Suit12 week, home-based programme whereby participants are encouraged to use the GMove suit daily, for at least 30 minutes a day. Recommended activities include walking, sit-to-stand and step-ups | Device | GMove Suit |
| Normal therapyParticipants are randomized to a normal therapy (physiotherapy) only program. Participants are also advised to undertake 30 mins a day of physical activity and have active physical therapy (physiotherapy) sessions. | Behavioural | Normal therapy |
Primary outcome
Central blood pressure
Time frame: Baseline, up to 12 weeks after baseline.
Pulse wave analysis (PWA) will investigate central blood pressure in mmHg following 15 minutes supine rest.
Peripheral blood pressure
Time frame: Baseline, up to 12 weeks after baseline.
Pulse wave analysis (PWA) will investigate peripheral blood pressure in mmHg following 15 minutes supine rest.
Augmentation Index
Time frame: Baseline, up to 12 weeks after baseline.
Pulse wave analysis (PWA) will investigate augmentation index as a percentage following 15 minutes supine rest.
Pulse Wave Velocity
Time frame: Baseline, up to 12 weeks after baseline.
Pulse wave velocity (PWV) will be recorded between the carotid (right and left) and femoral artery, brachial artery and femoral artery, and femoral artery and the anterior tibial artery. All PWV measures will be recorded in metres per second
12 secondary outcomes
Time-Up-And-Go
Time frame: Baseline, up to 12 weeks after baseline.
10 m walk test
Time frame: Baseline, up to 12 weeks after baseline.
6 minute walk test
Time frame: Baseline, up to 12 weeks after baseline.
Berg Balance
Time frame: Baseline, up to 12 weeks after baseline.
Balance Confidence Scale
Time frame: Baseline, up to 12 weeks after baseline.
Functional Ambulation Classification
Time frame: Baseline. Each assessment will take 2 minutes
Fugl-meyer assessment
Time frame: Baseline, up to 12 weeks after baseline.
Weight
Time frame: Baseline, up to 12 weeks after baseline.
Height
Time frame: Baseline, up to 12 weeks after baseline.
Body Mass Index (BMI)
Time frame: Baseline, up to 12 weeks after baseline.
Waist-to-Hip ratio
Time frame: Baseline, up to 12 weeks after baseline.
Sit to Stand
Time frame: Baseline, up to 12 weeks after baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 39964987Faulkner J, Paine E, Hudson N, Hannah S, Dennis-Jones A, Martinelli L, Hobbs H. Effect of using home-based dynamic intermittent pneumatic compression therapy during periods of physical activity on functional and vascular health outcomes in chronic stroke: A randomized controlled clinical trial. PLoS One. 2025 Feb 18;20(2):e0318942. doi: 10.1371/journal.pone.0318942. eCollection 2025.
- Individual participant dataSharing planned: Yes. All IPD outcome data that underpins publications will be shared with other researchers
Related trials for Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Jobson, PhD study director
University of Winchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GMove Suit and Normal therapy in people with Stroke, run by University of Winchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central blood pressure (time frame: Baseline, up to 12 weeks after baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05276453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.