Upper Limb Cross-education in Subacute Stroke

NCT ID: NCT04113369

Last Updated: 2020-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-30

Study Completion Date

2019-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates how cross-education (unilateral training) affects muscle strength of the paretic limb in acute stroke patients. Half of the hemiplegic patients will receive conventional treatment and transcutaneous electrical nerve stimulation (TENS) to non-paretic side, while other half will receive conventional treatment and electro muscular stimulation (EMS) to non-paretic side.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cross-education, which means the performance improvement in the untrained homologous muscle after unilateral exercise training, is studied in various orthopedical and neurological conditions affecting the body unilaterally. For those with asymmetrical weakness and immobility after stroke, training the non-paretic side can be utilized to increase the strength of the paretic side and improve functional symmetry. In this study, investigators aim was to examine whether training non-paretic upper extremity wrist flexor muscles by EMS in adjunct to conventional training program, has additional benefits upon the muscle powers of the homologous agonist and antagonist muscles. Investigators will use low frequency antalgic TENS stimulation at barely sensible level, which is considered not to cause muscle strengthening, as a control intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemiplegia Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TENS group

30 sessions (5 sessions/week, 6 weeks) of training including 40 minutes of lower limb training including a mixture of lower limb gait training, balance training and aerobic training and a combination of task-oriented treatment, fine motor skill training, range of motion exercises stretch exercises and strength training (75% repetition maximum (RM), 6 repetitions) for 20 minutes. After that training program, patients will receive 30 minutes of conventional antalgic TENS (100 Hz) program as controls with electrostimulation device to the non-paretic wrist flexors.

Group Type SHAM_COMPARATOR

TENS

Intervention Type DEVICE

30 minutes of conventional antalgic TENS to non-paretic forearm

Conventional rehabilitation

Intervention Type PROCEDURE

40 minutes of lower limb training and 20 minutes of upper extremity training for stroke

EMS group

0 sessions (5 sessions/week, 6 weeks) of training including 40 minutes of lower limb training including a mixture of lower limb gait training, balance training and aerobic training and a combination of task-oriented treatment, fine motor skill training, range of motion exercises stretch exercises and strength training (75% repetition maximum (RM), 6 repetitions) for 20 minutes. After that training, the patients will receive 20 minutes of electrical stimulation to their non-paretic forearm upon wrist flexors by an intermittent maximum strength program (6 seconds of contraction, 10 seconds of rest) along with 5 minutes of pre and post warm-up with the same device.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type PROCEDURE

40 minutes of lower limb training and 20 minutes of upper extremity training for stroke

EMS

Intervention Type DEVICE

20 minutes of EMS to non-paretic forearm with 5 minutes of pre and post warm-up

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TENS

30 minutes of conventional antalgic TENS to non-paretic forearm

Intervention Type DEVICE

Conventional rehabilitation

40 minutes of lower limb training and 20 minutes of upper extremity training for stroke

Intervention Type PROCEDURE

EMS

20 minutes of EMS to non-paretic forearm with 5 minutes of pre and post warm-up

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* thromboembolic stroke,
* \<6 months of stroke,
* right hand dominancy,
* left hemiplegia,
* Brunnstrom stage ≥ 3 of recovery for upper extremity and hand

Exclusion Criteria

* myopathy, tendinopathy, peripheral neuropathy of the upper extremities,
* auditory, cognitive or speech disorder that enables communication,
* history of fracture or arthrodesis in the upper limb,
* contracture or severe spasticity (Ashworth scale ≥ 2) in forearm muscles,
* severe cardiovascular disorders (heart failure, coronary artery disease, drug resistant hypertension)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ozan Volkan Yurdakul, MD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bezmialem University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Carroll TJ, Herbert RD, Munn J, Lee M, Gandevia SC. Contralateral effects of unilateral strength training: evidence and possible mechanisms. J Appl Physiol (1985). 2006 Nov;101(5):1514-22. doi: 10.1152/japplphysiol.00531.2006.

Reference Type BACKGROUND
PMID: 17043329 (View on PubMed)

Dragert K, Zehr EP. High-intensity unilateral dorsiflexor resistance training results in bilateral neuromuscular plasticity after stroke. Exp Brain Res. 2013 Mar;225(1):93-104. doi: 10.1007/s00221-012-3351-x. Epub 2012 Nov 30.

Reference Type BACKGROUND
PMID: 23196803 (View on PubMed)

Urbin MA, Harris-Love ML, Carter AR, Lang CE. High-Intensity, Unilateral Resistance Training of a Non-Paretic Muscle Group Increases Active Range of Motion in a Severely Paretic Upper Extremity Muscle Group after Stroke. Front Neurol. 2015 May 27;6:119. doi: 10.3389/fneur.2015.00119. eCollection 2015.

Reference Type BACKGROUND
PMID: 26074871 (View on PubMed)

Yurdakul OV, Kilicoglu MS, Rezvani A, Kucukakkas O, Eren F, Aydin T. How does cross-education affects muscles of paretic upper extremity in subacute stroke survivors? Neurol Sci. 2020 Dec;41(12):3667-3675. doi: 10.1007/s10072-020-04506-2. Epub 2020 Jun 6.

Reference Type DERIVED
PMID: 32506358 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-16/10

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ultrasonograpy in Hemiplegic Patients
NCT06706063 ACTIVE_NOT_RECRUITING