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

Sponsor
Vanesa Abuín (Other)
Overall Status
Recruiting
CT.gov ID
NCT04652934
Collaborator
Universidad Europea de Madrid (Other)
20
Enrollment
1
Location
2
Arms
10.2
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Neurodynamic
  • Other: Mimic group
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized 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
Actual Study Start Date :
Jan 26, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changes in Manual Ability [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 [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 [Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)]

    Dynamometer

  4. Changes in Nervous Conduction [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 [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 [Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)]

    Algometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federico Salniccia Madrid Spain 28670

Sponsors and Collaborators

  • Vanesa Abuín
  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

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:
Dec 3, 2020
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vanesa Abuín, PhD students Thesis Director, Universidad Europea de Madrid
Acquired Brain Injury
Hemiplegia
Neural Mobilization
Upper limb
Additional relevant MeSH terms:
Brain Injuries
Hemiplegia
Paresis
Wounds and Injuries

Study Results

No Results Posted as of May 18, 2022