Effect of Pressotherapy on Health Outcomes in Patients With Chronic Stroke

NCT05276453 | Completed DMC

• 1 other identifier: GMove_2022
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Central blood pressure

  Pulse wave analysis (PWA) will investigate central blood pressure in mmHg following 15 minutes supine rest.

  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.

  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.

  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

  Baseline, up to 12 weeks after baseline.

Secondary Outcomes (12)

• Time-Up-And-Go

  Baseline, up to 12 weeks after baseline.

• 10 m walk test

  Baseline, up to 12 weeks after baseline.

• 6 minute walk test

  Baseline, up to 12 weeks after baseline.

• Berg Balance

  Baseline, up to 12 weeks after baseline.

• Balance Confidence Scale

  Baseline, up to 12 weeks after baseline.

Other Outcomes (2)

• International Physical Activity Questionnaire Short-Form

  Baseline, up to 12 weeks after baseline.

• General Health Questionnaire -Short-Form-12 (SF12)

  Baseline, up to 12 weeks after baseline.

Study Arms (2)

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.

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.

Behavioral: Normal therapy

Interventions

GMove Suit DEVICE

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

GMove Suit

Normal therapy BEHAVIORAL

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.

Normal therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Winchester: lead
• Hobbs Rehabilitation: collaborator

Study Sites (1)

University of Winchester

Winchester, Hampshire, SO224NR, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Interventions

Immunization, Passive

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Simon Jobson, PhD

  University of Winchester

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised to either an experimental (Lower limb compression suit) or active comparator group

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 11, 2022
• Study Start: April 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Starting after 6 months of the first publication.
• Access Criteria: Available to all researchers interested in stroke rehabilitation research

Locations

GB (1)