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

July 28, 2023 updated by: Vanesa Abuín

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28670
        • Federico Salniccia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
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)
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
Changes in Muscle Strength
Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
Dynamometer
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
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)
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
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)
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
Changes in Upper Limb Pain to Pressure
Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
Algometer
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanesa Abuín

Collaborators

Universidad Europea de Madrid

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2022

Primary Completion (Actual)

July 28, 2023

Study Completion (Actual)

July 28, 2023

Study Registration Dates

First Submitted

October 8, 2020

First Submitted That Met QC Criteria

November 26, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUFA CEIC 20/154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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