Effectiveness of the Neural Mobilization on Upper Limb Functionality in Patients With Acquired Brain Injury
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04652934 |
Recruitment Status :
Not yet recruiting
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
---|---|---|
Hemiplegia and Hemiparesis Acquired Brain Injury | Other: Neurodynamic Other: Mimic group | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized 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 |
Estimated Study Start Date : | January 2021 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | December 2021 |
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. |
- Changes in Manual Ability [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]Abilhand Scale
- Changes in Life's Quality: Stroke Specific Health-Related Quality of Life Scale [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]Stroke Specific Health-Related Quality of Life Scale
- Changes in Range of Motion [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]Changes in articular movement angle
- Changes in Muscle Tone [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]Changes in muscle's structure using Myoton
- Changes in Muscle Stiffness [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]Changes in muscle's structure using Myoton
- Changes in Muscle Elasticity [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]Changes in muscle's structure using Myoton
- Changes in Muscle Spasticity [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]Modified Ashworth scale
- Changes in Muscle Strength [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]Dynamometer
- Changes in Nervous Conduction [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]SENIAM (surface eMG for non-invasive assessment of muscles)
- 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)
- Changes in Upper Limb Pain to Pressure [ Time Frame: Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention) ]Algometer

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years to 50 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652934
Contact: FEDERICO SALNICCIA, MSc | 0034646558521 | federico.salniccia@gmail.com |
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:
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: | December 3, 2020 Key Record Dates |
Last Update Posted: | December 3, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Acquired Brain Injury Hemiplegia Neural Mobilization Upper limb |
Brain Injuries Hemiplegia Paresis Wounds and Injuries Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Paralysis Neurologic Manifestations |