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NCT Number: NCT04652934

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

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.

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Key information

Conditions

Hemiplegia and Hemiparesis Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federico Salniccia

Madrid, 28670, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurodynamic

Other

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.

Mimic group

Other

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 outcomes

  1. Changes in Manual Ability

    Time frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

    Abilhand Scale; Score 0(worse outcome)-2(better outcome)

  2. Changes in Muscle Spasticity

    Time frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

    MAS (Modified Ashworth Scale) 0 (better outcome) - 4 (worse outcome)

  3. Changes in Muscle Strength

    Time frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

    Dynamometer

  4. Changes in Nervous Conduction

    Time frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

    Delsys Trigno Avanti (surface eMG for non-invasive assessment of muscles)

  5. 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) 0 (worse outcome) - 10 (better outcome)

  6. Changes in Upper Limb Pain to Pressure

    Time frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

    Algometer

Sponsors and collaborators

Lead sponsor

Vanesa Abuín

Other

Collaborators

  • Universidad Europea de Madrid

Registry information

Official study title

Effectiveness of the Neural Mobilization on Upper Limb Functionality in Patients With Acquired Brain Injury: Randomized, Controlled, Multi-Centric, Single-Blind Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 3, 2020
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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