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

NCT04652934 | Completed

• 1 other identifier: HUFA CEIC 20/154
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia and Hemiparesis; Acquired Brain Injury

Keywords

Acquired Brain Injury; Hemiplegia; Neural Mobilization; Upper limb

Outcome Measures

Primary Outcomes (6)

• Changes in Manual Ability

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

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

• Changes in Muscle Spasticity

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

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

• Changes in Muscle Strength

  Dynamometer

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

• Changes in Nervous Conduction

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

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

• Changes in Upper Limb Pain Perception

  EVA (Visual Analog Scale) 0 (worse outcome) - 10 (better outcome)

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

• Changes in Upper Limb Pain to Pressure

  Algometer

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Mimic group

SHAM COMPARATOR

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

Interventions

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.

Intervention group

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.

Mimic group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanesa Abuín: lead
• Universidad Europea de Madrid: collaborator

Study Sites (1)

Federico Salniccia

Madrid, 28670, Spain

Location

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Related Links

• Las personas con Daño Cerebral Adquirido en España

MeSH Terms

Conditions

Hemiplegia; Paresis; Brain Injuries

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Vanesa Abuín, Dr

  Universidad Europea de Madrid

  STUDY CHAIR

• Leticia Martínez, Dr

  Universidad Europea de Madrid

  STUDY DIRECTOR

• Almudena Buesa, Dr

  Universidad San Jorge de Zaragoza

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD students Thesis Director

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: December 3, 2020
• Study Start: January 26, 2022
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)