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Effectiveness of the Neural Mobilization on Upper Limb Functionality in Patients With Acquired Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04652934
Recruitment Status : Not yet recruiting
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
Sponsor:
Collaborator:
Universidad Europea de Madrid
Information provided by (Responsible Party):
Vanesa Abuín, Universidad Europea de Madrid

Brief Summary:

The main objective:

To determine changes in physiological and structural properties of upper limb muscles with spasticity in patients with acquired brain injury after applying neural mobilization improving their functional performance, their participation in society and quality of life.

Hypothesis:

Peripheral nerve mobilizations performed with neurodynamic techniques in upper limb in patients with acquired brain injury, generate changes at structural and physiological level, favoring the performance of daily life activities and improving the quality of life.


Condition or disease Intervention/treatment Phase
Hemiplegia and Hemiparesis Acquired Brain Injury Other: Neurodynamic Other: Mimic group Not Applicable

Detailed Description:

Randomized clinical trial with blinding of the subject, the evaluator and the person analyzing the data.

In the experimental group will be performed neural mobilitazion technique, while in the sham a technique to mimic neurodynamic.

The assessment will be made by a single evaluator.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the Neural Mobilization on Upper Limb Functionality in Patients With Acquired Brain Injury: Randomized, Controlled, Multi-Centric, Single-Blind Clinical Trial
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Intervention group
The Upper Limb Neurodynamic Test (ULNT1) technique described by Butler will be performed on the affected limb. This technique consists of performing shoulder depression, 90º shoulder abduction, hand, wrist and forearm in a neutral position, external rotation of the shoulder and extension of the elbow. After positioning the limb in this position, wrist flexion-extension movements will be performed smoothly and rhythmically of 20 movements every minute, for 3 minutes, three times per session with 1 minute of rest between each series.
Other: Neurodynamic
The Upper Limb Neurodynamic Test (ULNT1) technique described by Butler will be performed on the affected limb. This technique consists of performing shoulder depression, 90º shoulder abduction, hand, wrist and forearm in a neutral position, external rotation of the shoulder and extension of the elbow. After positioning the limb in this position, wrist flexion-extension movements will be performed smoothly and rhythmically of 20 movements every minute, for 3 minutes, three times per session with 1 minute of rest between each series.

Sham Comparator: Mimic group
The protocol used by Beneciuk et al. Will be used. This intervention consists of imitating NM without stressing the nervous system. It will be carried out as follow: a neutral cervical position will be maintained (0º of cervical inclination), 45º of shoulder abduction without depression, 45º of external rotation of the shoulder combined with 45º of elbow flexion with the forearm in pronation. Afterwards, 10 wrist flexion-extension movements will be performed at a rate of 6 seconds per cycle (3 seconds of flexion and 3 seconds of extension). The resistance that you will feel will stabilize when you change motion. Once the 10 cycles of movements have been carried out, a wrist flexion will be maintained for 10 seconds.
Other: Mimic group
The protocol used by Beneciuk et al. Will be used. This intervention consists of imitating NM without stressing the nervous system. It will be carried out as follow: a neutral cervical position will be maintained (0º of cervical inclination), 45º of shoulder abduction without depression, 45º of external rotation of the shoulder combined with 45º of elbow flexion with the forearm in pronation. Afterwards, 10 wrist flexion-extension movements will be performed at a rate of 6 seconds per cycle (3 seconds of flexion and 3 seconds of extension). The resistance that you will feel will stabilize when you change motion. Once the 10 cycles of movements have been carried out, a wrist flexion will be maintained for 10 seconds.




Primary Outcome Measures :
  1. Changes in Manual Ability [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]
    Abilhand Scale

  2. Changes in Life's Quality: Stroke Specific Health-Related Quality of Life Scale [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]
    Stroke Specific Health-Related Quality of Life Scale

  3. Changes in Range of Motion [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]
    Changes in articular movement angle

  4. Changes in Muscle Tone [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]
    Changes in muscle's structure using Myoton

  5. Changes in Muscle Stiffness [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]
    Changes in muscle's structure using Myoton

  6. Changes in Muscle Elasticity [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]
    Changes in muscle's structure using Myoton

  7. Changes in Muscle Spasticity [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]
    Modified Ashworth scale

  8. Changes in Muscle Strength [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]
    Dynamometer

  9. Changes in Nervous Conduction [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]
    SENIAM (surface eMG for non-invasive assessment of muscles)

  10. Changes in Upper Limb Pain Perception [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]
    EVA (Visual Analog Scale)

  11. Changes in Upper Limb Pain to Pressure [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]
    Algometer



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of acquired brain injury (hemiplegia-hemiparesis)
  • Ages between 25 and 50 years

Exclusion Criteria:

  • Unable to understand and respond to verbal instructions
  • Absence of voluntary movement in the upper limb
  • Take medicine for spasticity
  • Botulinum toxin infiltration in the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652934


Contacts
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Contact: FEDERICO SALNICCIA, MSc 0034646558521 federico.salniccia@gmail.com

Sponsors and Collaborators
Vanesa Abuín
Universidad Europea de Madrid
Investigators
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Study Chair: Vanesa Abuín, Dr Universidad Europea de Madrid
Study Director: Leticia Martínez, Dr Universidad Europea de Madrid
Study Chair: Almudena Buesa, Dr Universidad San Jorge de Zaragoza
Additional Information:
Publications:

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Responsible Party: Vanesa Abuín, PhD students Thesis Director, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT04652934    
Other Study ID Numbers: HUFA CEIC 20/154
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vanesa Abuín, Universidad Europea de Madrid:
Acquired Brain Injury
Hemiplegia
Neural Mobilization
Upper limb
Additional relevant MeSH terms:
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Brain Injuries
Hemiplegia
Paresis
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Paralysis
Neurologic Manifestations