Back to resultsEffectiveness of the Neural Mobilization on Upper Limb Functionality in Patients With Acquired Brain Injury
Primary Purpose
Hemiplegia and Hemiparesis, Acquired Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neurodynamic
Mimic group
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegia and Hemiparesis focused on measuring Acquired Brain Injury, Hemiplegia, Neural Mobilization, Upper limb
Eligibility Criteria
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
Sites / Locations
- Federico Salniccia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention group
Mimic group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in Manual Ability
Abilhand Scale; Score 0(worse outcome)-2(better outcome)
Changes in Muscle Spasticity
MAS (Modified Ashworth Scale) 0 (better outcome) - 4 (worse outcome)
Changes in Muscle Strength
Dynamometer
Changes in Nervous Conduction
Delsys Trigno Avanti (surface eMG for non-invasive assessment of muscles)
Changes in Upper Limb Pain Perception
EVA (Visual Analog Scale) 0 (worse outcome) - 10 (better outcome)
Changes in Upper Limb Pain to Pressure
Algometer
Secondary Outcome Measures
Full Information
NCT ID
NCT04652934
First Posted
October 8, 2020
Last Updated
July 28, 2023
Sponsor
Vanesa Abuín
Collaborators
Universidad Europea de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04652934
Brief Title
Effectiveness of the Neural Mobilization on Upper Limb Functionality in Patients With Acquired Brain Injury
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
July 28, 2023 (Actual)
Study Completion Date
July 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vanesa Abuín
Collaborators
Universidad Europea de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia and Hemiparesis, Acquired Brain Injury
Keywords
Acquired Brain Injury, Hemiplegia, Neural Mobilization, Upper limb
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Mimic group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neurodynamic
Intervention Description
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 Type
Other
Intervention Name(s)
Mimic group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Manual Ability
Description
Abilhand Scale; Score 0(worse outcome)-2(better outcome)
Time Frame
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
Title
Changes in Muscle Spasticity
Description
MAS (Modified Ashworth Scale) 0 (better outcome) - 4 (worse outcome)
Time Frame
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
Title
Changes in Muscle Strength
Description
Dynamometer
Time Frame
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
Title
Changes in Nervous Conduction
Description
Delsys Trigno Avanti (surface eMG for non-invasive assessment of muscles)
Time Frame
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
Title
Changes in Upper Limb Pain Perception
Description
EVA (Visual Analog Scale) 0 (worse outcome) - 10 (better outcome)
Time Frame
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
Title
Changes in Upper Limb Pain to Pressure
Description
Algometer
Time Frame
Pre-intervention; Immediately after the intervention; Follow up (1 week after the intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanesa Abuín, Dr
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leticia Martínez, Dr
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Almudena Buesa, Dr
Organizational Affiliation
Universidad San Jorge de Zaragoza
Official's Role
Study Chair
Facility Information:
Facility Name
Federico Salniccia
City
Madrid
ZIP/Postal Code
28670
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://fedace.org/index.php?&PHPSESSID=3j4ek0jllf4n07r3qvb140nki4&V_dir=MSC&V_mod=download&f=2016-9/26-16-4-11.admin.Informe_FEDACE_RPD_para_DDC-1.pdf
Description
Las personas con Daño Cerebral Adquirido en España
URL
http://www.imserso.es/InterPresent2/groups/imserso/documents/binario/neuropsicologia.pdf
Description
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)
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Effectiveness of the Neural Mobilization on Upper Limb Functionality in Patients With Acquired Brain Injury
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