Characterising the Neuromuscular Function of Post Stroke Patients

NCT07013188 | Recruiting

• 1 other identifier: FMHS 188-0524
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Strokes are a leading cause of death and disability in developed countries, with significant economic and social impacts. Defined by the WHO, strokes cause rapid and lasting disturbances in cerebral function. In the UK, strokes occur every five minutes, affecting 100,000 people annually and resulting in substantial physical impairments and financial costs. Although stroke-related deaths have decreased due to improved treatments and awareness, strokes remain a major cause of death and disability worldwide, especially in lower-income countries. Strokes typically cause unilateral deficits, leading to significant daily challenges and necessitating tailored rehabilitation strategies such as CIMT, FES, and VR Rehab. As the population ages, innovative neurorehabilitation approaches are essential to enhance functional recovery post-stroke. This pilot study aims to better understand the neuromuscular deficits caused by stroke to inform and improve future rehabilitation interventions, including the potential use of force accuracy training (FAT)

Conditions

Stroke (CVA) or TIA

Keywords

Stroke; CVA; TIA; Neuromuscular

Outcome Measures

Primary Outcomes (4)

• Isometric dynamometry

  to determine maximum voluntary contraction (MVC) for upper and lower limb extension and flexion, including handgrip dynamometry (in Newton unit)

  During the single testing session (baseline) for the eligible stroke survivors who had a stroke within the past 5 years

• High-Density Surface electromyography (HDsEMG) and intramuscular electromyography (iEMG) of the muscles of the upper (bicep and tricep) and lower limbs (vastus lateralis and tibialis anterior) to determine muscle activation patterns

  Intramuscular electromyography (iEMG) and high-density sEMG (HD-sEMG) will be used to determine motor unit structure (size \& number) and function (firing rate, firing complexity, neuromuscular junction transmission reliability). sEMG will also be used to determine muscle activation patterns and the largest compound muscle action potential (M-wave). This will be performed using skin electrodes (HDsEMG) and a small pin-type electrode (iEMG) inserted into the upper and lower limb muscles (measured in µVms).

  During the single testing session (baseline) for the eligible stroke survivors who had a stroke within the past 5 years

• Motor control assessments for the upper and lower limbs (i.e., force tracking tasks for knee and elbow extension).

  Participants will be requested to follow a force trace line on a monitor during extension and flexion movements. The intensity of this force will be relative to their individual capabilities (measured as CoV of force)

  During the single testing session (baseline) for the eligible stroke survivors who had a stroke within the past 5 years

• Balance tests

  Using a platform that can assess features such as Centre of Pressure (COP) and sway, participants will be asked to stand on both feet, and then on one foot with their eyes open and closed. Time to failure (i.e., need to place second foot on the floor and/or open eyes) will be recorded. A chair will be located behind participants for this assessment and a researcher will remain within touching distance. Participants will only be requested to complete the aspects of this assessment that they feel comfortable doing (measured in millimeter).

  During the single testing session (baseline) for the eligible stroke survivors who had a stroke within the past 5 years

Secondary Outcomes (2)

• The Grooved Pegboard Test to assess dexterity

  During the single testing session (baseline) for the eligible stroke survivors who had a stroke within the past 5 years

• The Trail Making Test (TMT)

  During the single testing session (baseline) for the eligible stroke survivors who had a stroke within the past 5 years

Study Arms (1)

Stroke patients

* Aged between 40-85 years * Willing and able to give informed consent for participation in the study * Had a confirmed stroke within the last 5 years * Self-reports persisting post-stroke loss of unilateral limb function

Other: Neuromuscular function

Interventions

Neuromuscular function OTHER

Assessing their neuromuscular abilities using some functional and electromyography assessments

Stroke patients

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Post-stroke survival

You may qualify if:

• Aged between 40-85 years
• Willing and able to give informed consent for participation in the study
• Had a confirmed stroke within the last 5 years
• Self-reports persisting post-stroke loss of unilateral limb function

You may not qualify if:

• Diagnosis of cognitive impairment/dementia
• Current or recent (\<2y) malignancy
• Severe respiratory disease (e.g., uncontrolled asthma, COPD, pulmonary hypertension)
• Active cardiovascular disease: Uncontrolled hypertension (BP\>160/100mmHg); Recent (\<12mo) cardiac event; Heart failure (Class III/IV); Significant arrhythmia; Unstable angina
• Metabolic disease: Untreated hyper/hypoparathyroidism; Cushing's disease
• Significant musculoskeletal disorders (based on clinical opinion)
• Dialysis patients
• Recent steroid treatment within 6 months or hormone replacement therapy
• Mobility dependant (wheelchair dependency)

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Royal Derby Hospital branch, School of Medicine, University of Nottingham

Derby, Derbyshire, DE22 3DT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: June 10, 2025
• Study Start: June 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: May 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)