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

Acquired Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04652934
• Other study ID #: HUFA CEIC 20/154
• Status: Completed
• Phase: N/A
• Start date: January 26, 2022
• Est. completion date: July 28, 2023

Study information

• Verified date: July 2023
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 28, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Hemiplegia
• Hemiplegia and Hemiparesis
• Paresis
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Federico Salniccia	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Vanesa Abuín	Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Changes in Muscle Strength	Dynamometer	Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
Primary	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)
Primary	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)
Primary	Changes in Upper Limb Pain to Pressure	Algometer	Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)

External Links

•   Las personas con Daño Cerebral Adquirido en España
•   Neuropsicología Cognitiva. Aplicaciones a la clínica y a la investigación Fundamento teórico y metedológico de la Neuropsicología Cognitiva [Internet]. Madrid: Instituto de Migraciones y Servicios Sociales (IMSERSO)